Upcoming Product-Specific Guidances for Generic Drug Product Development
Introduction
This web page provides information related to upcoming new and revised product-specific guidances (PSGs) to support the development and approval of safe and effective generic drug products, including the projected date of PSG publication, as a commitment under the Generic Drug User Fee Amendments of 2022 (GDUFA III). Upcoming PSGs for both complex and non-complex products that are planned to be published in the next 12 months are listed (these may be subject to change).
How often does FDA publish new and revised PSGs?
To support generic drug development and generic drug approval, FDA issues new and revised PSGs on a quarterly and as needed basis. These PSGs, including PSGs for both complex and non-complex generic drug products, when finalized, describe the agency's current thinking and expectations on how to develop generic drug products to specific reference listed drugs and are intended to assist the generic pharmaceutical industry with identifying the most appropriate methodology and evidence needed to support a specific generic drug’s approval. The published PSGs are announced in the Federal Register and made available to the public on FDA’s website.
What information is provided on this web page?
For new PSGs for generic drug products under development, this web page provides information on the active ingredient(s), the route of administration and dosage form, the reference listed drug (RLD) application number, and the planned publication month/year. In addition to this information, the list of PSGs for generic products under revision also includes the planned revision categories and brief descriptions. This web page describes FDA’s plans for issuing new and revised PSGs for both complex and non-complex generic drug products.
What do the different planned revision categories mean?
For revised PSGs, the planned revision categories briefly describe the nature of the anticipated revisions. Planned revision categories are defined as the following:
- Critical revision: PSG revision includes additional bioequivalence (BE) study(ies) or evidence recommended that is necessary to establish BE and support FDA approval reflecting a change in the safety or effectiveness of the drug product. The critical revision has a potential impact on all ANDAs including the approved applications. Holders of approved applications are also expected to address the change in the safety or effectiveness of the drug product reflected in a critical revision to maintain its FDA approval.
- Major revision: PSG revision includes additional BE study(ies) or evidence recommended that is necessary to establish BE and support FDA approval. Major revisions are categorized as in vivo major revisions and in vitro major revisions. Under GDUFA III, applicants or prospective applicants may request PSG teleconference if they have already commenced an in vivo bioequivalence study (i.e., the study protocol has been signed by the study sponsor and/or the contract research organization) to obtain Agency feedback on the potential impact of the new or revised PSG on its development program. Pre-submission or post-submission PSG meetings may be requested following feedback received at the PSG teleconference. Refer to GDUFA III Enhancements to the Pre-ANDA Program for additional details.
- In vivo major revision: PSG revision includes additional in vivo bioequivalence study(ies) or evidence recommended to support FDA approval.
- In vitro major revision: PSG revision includes additional in vitro bioequivalence study(ies) or evidence recommended to support FDA approval.
- Minor revision: Any revision to a PSG that is not considered critical or major, including but not limited to when a PSG is to be revised to add an in vivo or in vitro BE option, to clarify recommended study design, to certain study(ies), to provide alternative (less burdensome) approaches to the currently recommended study(ies), to add information on newly approved strengths of the RLD, or to make other recommendations that would not generally result in additional recommended bioequivalence study(ies) or evidence by an ANDA applicant necessary to support FDA approval. Minor revisions include both in vivo and in vitro changes.
- Editorial revision: PSG revision includes non-substantive changes such as updating external references, correcting grammatical issues, and streamlining the format of existing recommendations.
FDA will also provide specific information on the planned revision when such information is available for public release.
What is a complex generic drug product?
As described in the GDUFA III Commitment Letter and Classifying Approved New Drug Products and Drug-device Combination Products as Complex Products for Generic Drug Development Purposes (MAPP 5240.10), a complex generic drug product generally means the following:
- A product with:
- a complex active ingredient(s) (e.g., peptides, polymeric compounds, complex mixtures of APIs, naturally sourced ingredients)
- a complex formulation (e.g., liposomes, colloids)
- a complex route of delivery (e.g., locally acting drugs such as dermatological products and complex ophthalmological products and otic dosage forms that are formulated as suspensions, emulsions, or gels)
- a complex dosage form (e.g., transdermals, metered dose inhalers, extended release injectables)
- Complex drug-device combination products (e.g., auto injectors, metered dose inhalers); and
- Other products where complexity or uncertainty concerning the approval pathway or possible alternative approaches would benefit from early scientific engagement.
How often does FDA update this web page?
This web page will be updated each time FDA issues a new quarterly PSG batch. Each update removes the published PSGs and adds any new PSG under development or revision. This advance notice will help generic drug companies to plan for their development of generic drug products.
New and Revised PSGs for Generic Drug Products
Below is the list of PSGs for both complex and non-complex generic drug products that FDA plans to issue and the list of PSGs that FDA plans to revise in the coming year. While this list reflects FDA’s effort to be transparent regarding current plans for developing PSGs for generic drug products, it should be noted that timing may be subject to change.
Planned New PSGs for Complex and Non-Complex
Generic Drug Products
Updated: July 14, 2025
| Active Ingredient(s) | Route of Administration | Dosage Form | RLD or RS Application Number | Product Complexity | Planned Publication | Updates |
|---|---|---|---|---|---|---|
| Abiraterone Acetate; Niraparib Tosylate | Oral | Tablet | 216793 | Non-Complex | 08/2025 | Planned publication date change to a later date |
| Acroamidis Hydrochloride | Oral | Tablet | 216540 | Non-Complex | 11/2025 | No Change |
| Amikacin Sulfate | Inhalation | Suspension, Liposomal | 207356 | Complex | Beyond 12 months | No Change |
| Aprocitentan | Oral | Tablet | 217686 | Non-Complex | 09/2025 | Planned publication date change to a later date |
| Arimoclomol Citrate | Oral | Capsule | 214927 | Non-Complex | 11/2025 | No Change |
| Aripiprazole | Oral | Tablet | 207202 | Complex | Within the next 12 months | No Change |
| Aripiprazole | Oral | Solution | 021713 | Non-Complex | 11/2025 | No Change |
| Berdazimer Sodium | Topical | Gel | 217424 | Complex | 09/2025 | Planned publication date change to a later date |
| Budesonide | Oral | Suspension | 213976 | Complex | 09/2025 | Planned publication date change to a later date |
| Bupivacaine; Meloxicam | Periarticular | Solution, Extended Release | 211988 | Complex | 08/2025 | Planned publication date change to a later date |
| Buprenorphine | Subcutaneous | Solution, Extended Release | 210136 | Complex | 02/2026 | Planned publication date change to a later date |
| Cabergoline | Oral | Tablet | 020664 | Non-Complex | 11/2025 | No Change |
| Capivasertib | Oral | Tablet | 218197 | Non-Complex | 08/2025 | Planned publication date change to a later date |
| Carbidopa; Levodopa | Oral | Capsule, Extended Release | 217186 | Non-Complex | 09/2025 | Planned publication date change to a later date |
| Carbidopa; Levodopa | Oral | Tablet | 214869 | Non-Complex | 09/2025 | Planned publication date change to a later date |
| Cefepime Hydrochloride; Enmetazobactam | Intravenous | Powder | 216165 | Non-Complex | 11/2025 | No Change |
| Cephalexin | Oral | Tablet | 063024 | Non-Complex | Within the next 12 months | No Change |
| Clobetasol Propionate | Topical | Cream | 209483 | Complex | Beyond 12 months | No Change |
| Crinecerfont | Oral | Capsule | 218808 | Non-Complex | 11/2025 | No Change |
| Crinecerfont | Oral | Solution | 218820 | Non-Complex | 11/2025 | No Change |
| Crizotinib | Oral | Capsule, Pellets | 217581 | Non-Complex | 08/2025 | Planned publication date change to a later date |
| Danicopan | Oral | Tablet | 218037 | Non-Complex | 09/2025 | Planned publication date change to a later date |
| Dasatinib | Oral | Tablet | 216099 | Non-Complex | 09/2025 | Planned publication date change to a later date |
| Desmopressin Acetate | Nasal | Spray, Metered | 201656 | Complex | 11/2025 | No Change |
| Deuruxolitinib Phosphate | Oral | Tablet | 217900 | Non-Complex | 09/2025 | Planned publication date change to a later date |
| Deutivacaftor; Tezacaftor; Vanzacaftor Calcium | Oral | Tablet | 218730 | Non-Complex | 11/2025 | No Change |
| Dexamethasone | Intravitreal | Implant | 022315 | Complex | 09/2025 | Planned publication date change to a later date |
| Dexmedetomidine Hydrochloride | Buccal; Sublingual | Film | 215390 | Non-Complex | 08/2025 | Planned publication date change to a later date |
| Elafibranor | Oral | Tablet | 218860 | Non-Complex | 11/2025 | No Change |
| Eltrombopag Choline | Oral | Tablet | 216774 | Non-Complex | 09/2025 | Planned publication date change to a later date |
| Ensartinib Hydrochloride | Oral | Capsule | 218171 | Non-Complex | 11/2025 | No Change |
| Ensifentrine | Inhalation | Suspension | 217389 | Complex | 08/2025 | Planned publication date change to a later date |
| Estradiol | Vaginal | Insert | 208564 | Complex | Within the next 12 months | No Change |
| Estradiol; Norethindrone Acetate; Relugolix | Oral | Tablet | 214846 | Non-Complex | 11/2025 | No Change |
| Estradiol;Progesterone | Oral | Capsule | 210132 | Non-Complex | 11/2025 | No Change |
| Ezetimibe; Rosuvastatin Calcium | Oral | Tablet | 213072 | Non-Complex | 11/2025 | No Change |
| Fenfluramine Hydrochloride | Oral | Solution | 212102 | Non-Complex | 11/2025 | No Change |
| Flunisolide | Inhalation | Aerosol, Metered | 021247 | Complex | 09/2025 | Planned publication date change to a later date |
| Flurpiridaz F-18 | Intravenous | Solution | 215168 | Non-Complex | 11/2025 | No Change |
| Foscarbidopa; Foslevodopa | Subcutaneous | Solution | 216962 | Complex | 02/2026 | No Change |
| Fruquintinib | Oral | Capsule | 217564 | Non-Complex | 08/2025 | Planned publication date change to a later date |
| Givinostat Hydrochloride | Oral | Suspension | 217865 | Non-Complex | 09/2025 | Planned publication date change to a later date |
| Glucagon | Injection | Injectable | 020928 | Complex | 09/2025 | Planned publication date change to a later date |
| Glycopyrrolate | Oral | Tablet, Oral Disintegrating | 215019 | Non-Complex | 08/2025 | Planned publication date change to a later date |
| Ibrutinib | Oral | Suspension | 217003 | Non-Complex | 08/2025 | Planned publication date change to a later date |
| Imetelstat Sodium | Intravenous | Powder | 217779 | Complex | 02/2026 | No Change |
| Inavolisib | Oral | Tablet | 219249 | Non-Complex | 09/2025 | Planned publication date change to a later date |
| Iomeprol | Intra-arterial | Solution | 216016 | Non-Complex | 11/2025 | No Change |
| Iomeprol | Intravenous | Solution | 216017 | Non-Complex | 11/2025 | No Change |
| Itraconazole | Oral | Solution | 020657 | Non-Complex | 11/2025 | No Change |
| Ketorolac Tromethamine; Phenylephrine Hydrochloride | Irrigation | Solution | 205388 | Non-Complex | Within the next 12 months | Planned publication date change to a later date |
| Lacosamide | Oral | Solution | 022255 | Non-Complex | 11/2025 | No Change |
| Landiolol Hydrochloride | Intravenous | Powder | 217202 | Non-Complex | 02/2026 | No Change |
| Lanreotide Acetate | Subcutaneous | Solution | 215395 | Complex | Within the next 12 months | No change |
| Lazertinib Mesylate | Oral | Tablet | 219008 | Non-Complex | 09/2025 | Planned publication date change to a later date |
| Levacetylleucine | Oral | For Suspension | 219132 | Non-Complex | 11/2025 | No Change |
| Levamlodipine Maleate | Oral | Tablet | 212895 | Non-Complex | 11/2025 | No Change |
| L-Glutamine | Oral | For Solution | 208587 | Non-Complex | 11/2025 | No Change |
| Lidocaine; Tetracaine | Topical | Patch | 021623 | Complex | Beyond 12 months | No Change |
| Mavorixafor | Oral | Capsule | 218709 | Non-Complex | 09/2025 | Planned publication date change to a later date |
| Metronidazole | Oral | Suspension | 216755 | Non-Complex | 09/2025 | Planned publication date change to a later date |
| Minocycline Hydrochloride | Oral | Capsule, Extended Release | 219015 | Non-Complex | 09/2025 | Planned publication date change to a later date |
| Mometasone Furoate | Implantation | Implant | 209310 | Complex | Within the next 12 months | Planned publication date change to a later date |
| Nalmefene Hydrochloride | Intramuscular, Subcutaneous | Solution | 218590 | Complex | 08/2025 | Planned publication date change to a later date |
| Naloxone Hydrochloride | Nasal | Spray | 215487 | Complex | 08/2025 | Planned publication date change to a later date |
| Nicotine | Oral | Inhalant | 020714 | Complex | 11/2025 | No Change |
| Nilotinib Tartrate | Oral | Tablet | 219293 | Non-Complex | 09/2025 | Planned publication date change to a later date |
| Nimodipine | Oral | Solution | 203340 | Non-Complex | 11/2025 | No Change |
| Nirogacestat Hydrobromide | Oral | Tablet | 217677 | Non-Complex | 08/2025 | Planned publication date change to a later date |
| Olezarsen Sodium | Subcutaneous | Solution | 218614 | Complex | 02/2026 | No Change |
| Oxaprozin | Oral | Capsule | 217927 | Non-Complex | 09/2025 | Planned publication date change to a later date |
| Paliperidone Palmitate | Intramuscular | Suspension, Extended Release | 216352 | Complex | 02/2026 | No Change |
| Palopegteriparatide | Subcutaneous | Solution | 216490 | Complex | 02/2026 | No Change |
| Patiromer Sorbitex Calcium | Oral | Powder | 205739 | Complex | Within the next 12 months | No Change |
| Pegulicianine Acetate | Intravenous | Powder | 214511 | Complex | 11/2025 | No Change |
| Pemetrexed Dipotassium | Intravenous | Powder | 210661 | Non-Complex | 08/2025 | Planned publication date change to a later date |
| Pivmecillinam Hydrochloride | Oral | Tablet | 216483 | Non-Complex | 11/2025 | Planned publication date change to a later date |
| Prednisolone Acetate | Ophthalmic | Suspension/Drops | 017100 | Complex | 08/2025 | Planned publication date change to a later date |
| Primidone | Oral | Orally Disintegrating Tablet | FDA-2009-P-0481 | Non-Complex | 11/2025 | Planned publication date change to a later date |
| Probenecid; Sulopenem Etzadroxil | Oral | Tablet | 213972 | Non-Complex | 09/2025 | Planned publication date change to a later date |
| Resmetirom | Oral | Tablet | 217785 | Non-Complex | 09/2025 | Planned publication date change to a later date |
| Revumenib Citrate | Oral | Tablet | 218944 | Non-Complex | 11/2025 | No Change |
| Roflumilast | Topical | Foam | 217242 | Complex | 11/2025 | No Change |
| Sacubitril; Valsartan | Oral | Capsule, Pellets | 218591 | Non-Complex | 09/2025 | Planned publication date change to a later date |
| Sapropterin Dihydrochloride | Oral | Powder | 205065 | Non-Complex | 08/2025 | Planned publication date change to a later date |
| Seladelpar Lysine | Oral | Capsule | 217899 | Non-Complex | 09/2025 | Planned publication date change to a later date |
| Selpercatinib | Oral | Tablet | 218160 | Non-Complex | 11/2025 | No Change |
| Sofpironium Bromide | Topical | Gel, Metered | 217347 | Complex | 08/2025 | Planned publication date change to a later date |
| Tenapanor Hydrochloride | Oral | Tablet | 213931 | Complex | 11/2025 | Planned publication date change to a later date |
| Teriparatide | Subcutaneous | Solution | 218771 | Complex | 11/2025 | No Change |
| Tirzepatide | Subcutaneous | Solution | 217806 | Complex | 09/2025 | Planned publication date change to a later date |
| Tovorafenib | Oral | For Suspension | 218033 | Non-Complex | 09/2025 | Planned publication date change to a later date |
| Tovorafenib | Oral | Tablet | 217700 | Non-Complex | 09/2025 | Planned publication date change to a later date |
| Travoprost | Intracameral | Implant | 218010 | Complex | 09/2025 | Planned publication date change to a later date |
| Trospium Chloride; Xanomeline Tartrate | Oral | Capsule | 216158 | Non-Complex | 09/2025 | Planned publication date change to a later date |
| Vadadustat | Oral | Tablet | 215192 | Non-Complex | 09/2025 | Planned publication date change to a later date |
| Valbenazine Tosylate | Oral | Capsule | 218390 | Non-Complex | 09/2025 | Planned publication date change to a later date |
| Valganciclovir Hydrochloride | Oral | For Solution | 022257 | Non-Complex | 11/2025 | No Change |
| Vonoprazan Fumarate | Oral | Tablet | 215151 | Non-Complex | 08/2025 | Planned publication date change to a later date |
| Vorasidenib | Oral | Tablet | 218784 | Non-Complex | 09/2025 | Planned publication date change to a later date |
Planned Revised PSGs for Complex and Non-Complex
Generic Drug Products
Updated: July 14, 2025
| Active Ingredient(s) | Route Of Administration | Dosage Form | RLD or RS Application Number | Planned Revision Category with Description | Product Complexity | Planned Publication | Updates |
|---|---|---|---|---|---|---|---|
| Copper Cu-64 Dotatate | Intravenous | Solution | 213227 | Editorial Revision: Update the language to match Orange Book | Non-Complex | 09/2025 | Newly Added |
| Gallium Ga-68 Edotreotide | Intravenous | Solution | 210828 | Editorial Revision: Update the language to match Orange Book | Non-Complex | 09/2025 | Newly Added |
| Lutetium Lu 177 Dotatate | Intravenous | Solution | 208700 | Editorial Revision: Update the language to match Orange Book | Complex | 09/2025 | Newly Added |
| Neratinib Maleate | Oral | Tablet | 208051 | In Vivo Major Revision: Correct error in in vivo study design recommendation caused by a processing error | Non-Complex | 09/2025 | Newly Added |
| Abiraterone Acetate | Oral | Tablet | 202379 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 08/2025 | Planned publication date change to a later date |
| Acetaminophen; Butalbital | Oral | Capsule | 088831 | Minor Revision: Remove recommendation on a strength due to safety concerns | Non-Complex | 08/2025 | Planned publication date change to a later date |
| Aclidinium Bromide | Inhalation | Powder, Metered | 202450 | Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE option | Complex | 09/2025 | Planned publication date change to a later date |
| Aclidinium Bromide; Formoterol Fumarate | Inhalation | Powder, Metered | 210595 | Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE option | Complex | 09/2025 | Planned publication date change to a later date |
| Albuterol Sulfate | Inhalation | Powdered, Metered | 205636 | Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE option | Complex | 08/2025 | Planned publication date change to a later date |
| Alectinib Hydrochloride | Oral | Capsule | 208434 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 08/2025 | Planned publication date change to a later date |
| Amantadine Hydrochloride | Oral | Capsule, Extended Release | 208944 | Minor Revision: Remove recommendations on in vitro test | Non-Complex | 08/2025 | Planned publication date change to a later date |
| Ambrisentan | Oral | Tablet | 022081 | Minor Revision: Remove recommendations on REMS/ETASU | Non-Complex | 09/2025 | Planned publication date change to a later date |
| Amifampridine | Oral | Tablet | 208078 | In Vitro Major Revision: Add an in vitro study(ies) | Non-Complex | 08/2025 | Planned publication date change to a later date |
| Amino Acids; Calcium Chloride; Dextrose; Magnesium Sulfate; Potassium Chloride; Sodium Acetate; Sodium Glycerophosphate; Soybean Oil | Intravenous | Emulsion | 200656 | Minor Revision: Remove recommendations on in vitro test; Provide more details on in vitro testing; Add recommendations for device comparisons | Complex | 09/2025 | Planned publication date change to a later date |
| Amphetamine | Oral | Tablet, Orally Disintegrating, Extended Release | 204326 | Minor Revision: Clarify in vitro BE study | Non-Complex | 09/2025 | Planned publication date change to a later date |
| Asciminib Hydrochloride | Oral | Tablet | 215358 | In Vivo Major Revision: Change in study design for in vivo BE study(ies) (to add a new higher strength) | Non-Complex | 09/2025 | Planned publication date change to a later date |
| Aspirin | Oral | Capsule, extended release | 200671 | Minor Revision: Remove recommendations on in vitro test | Non-Complex | 08/2025 | Planned publication date change to a later date |
| Azilsartan Kamedoxomil | Oral | Tablet | 200796 | Minor Revision: Clarify in vivo study design | Non-Complex | 08/2025 | Planned publication date change to a later date |
| Azilsartan Kamedoxomil; Chlorthalidone | Oral | Tablet | 202331 | Minor Revision: Clarify in vivo study design | Non-Complex | 08/2025 | Planned publication date change to a later date |
| Beclomethasone Dipropionate | Inhalation | Aerosol, Metered | 020911 | Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE option | Complex | 09/2025 | Planned publication date change to a later date |
| Beclomethasone Dipropionate | Inhalation | Aerosol, Metered | 207921 | Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE option | Complex | 09/2025 | Planned publication date change to a later date |
| Betamethasone Acetate; Betamethasone Sodium Phosphate | Injection | Injectable | 014602 | Minor Revision: Clarify in vitro study design; Provide more details on in vitro testing | Complex | 08/2025 | Planned publication date change to a later date |
| Betaxolol Hydrochloride | Ophthalmic | Suspension/Drops | 019845 | Minor Revision: Clarify in vivo study design | Complex | 08/2025 | Planned publication date change to a later date |
| Bosentan | Oral | Tablet | 021290 | Minor Revision: Remove recommendations on REMS/ETASU | Non-Complex | 09/2025 | Planned publication date change to a later date |
| Bosentan | Oral | Tablet, for Suspension | 209279 | Minor Revision: Remove recommendations on REMS/ETASU | Non-Complex | 09/2025 | Planned publication date change to a later date |
| Brimonidine Tartrate | Ophthalmic | Solution/Drops | 021770 | Minor Revision: Clarify in vivo study design | Non-Complex | 08/2025 | Planned publication date change to a later date |
| Brimonidine Tartrate | Ophthalmic | Solution/Drops | 021262 | Minor Revision: Clarify in vivo study design | Non-Complex | 08/2025 | Planned publication date change to a later date |
| Brimonidine Tartrate; Brinzolamide | Ophthalmic | Suspension/Drops | 204251 | Minor Revision: Clarify in vivo study design | Complex | 08/2025 | Planned publication date change to a later date |
| Brinzolamide | Ophthalmic | Suspension/Drops | 020816 | Minor Revision: Clarify in vivo study design | Complex | 08/2025 | Planned publication date change to a later date |
| Budesonide | Inhalation | Powder, Metered | 021949 | Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE option | Complex | 09/2025 | Planned publication date change to a later date |
| Buprenorphine Hydrochloride | Buccal | Film | 207932 | Minor Revison: Clarify in vitro study design | Non-Complex | 09/2025 | Planned publication date change to a later date |
| Cabotegravir | Intramuscular | Suspension, Extended Release | 215499 | Minor Revision: Clarify in vivo study design | Complex | 08/2025 | Planned publication date change to a later date |
| Cabotegravir; Rilpivirine | Intramuscular | Suspension, Extended Release | 212888 | Minor Revision: Clarify in vivo study design | Complex | 08/2025 | Planned publication date change to a later date |
| Calcitonin Salmon | Injection | Injectable | 017808 | Minor Revision: Provide more details on in vitro testing | Complex | 11/2025 | Planned publication date change to a later date |
| Carglumic Acid | Oral | Tablet, for suspension | 022562 | In Vitro Major Revision: Add an in vitro study(ies) | Non-Complex | 08/2025 | Planned publication date change to a later date |
| Ciclesonide | Inhalation | Aerosol, Metered | 021658 | Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE option | Complex | 09/2025 | Planned publication date change to a later date |
| Clevidipine | Intravenous | Emulsion | 022156 | Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances | Complex | 08/2025 | Planned publication date change to a later date |
| Clotrimazole | Topical | Cream | 017619 | Editorial Revision: Update the languageMinor Revision: Add an in vitro BE option | Complex | 08/2025 | Planned publication date change to a later date |
| Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Disoproxil Fumarate | Oral | Tablet | 203100 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 08/2025 | Planned publication date change to a later date |
| Crofelemer | Oral | Tablet, Delayed Release | 202292 | Minor Revision: Expand the eligibility for an in vitro-based BE option | Complex | 09/2025 | Planned publication date change to a later date |
| Cyclobenzaprine Hydrochloride | Oral | Capsule, Extended Release | 021777 | Minor Revision: Remove recommendations on in vitro test | Non-Complex | 08/2025 | Planned publication date change to a later date |
| Dasiglucagon Hydrochloride | Subcutaneous | Solution | 214231 | Minor Revision: Provide more details on in vitro testing | Complex | 11/2025 | Planned publication date change to a later date |
| Diazepam | Oral | Tablet | 013263 | Minor Revision: Change in study design for in vivo BE study (ies) | Non-Complex | 09/2025 | Planned publication date change to a later date |
| Dorzolamide Hydrochloride | Ophthalmic | Solution/Drops | 020408 | Minor Revision: Clarify in vivo study design | Non-Complex | 08/2025 | Planned publication date change to a later date |
| Epinephrine | Intramuscular, Subcutaneous | Injectable | 020800 | Editorial Revision: Update the languageMinor Revision: Revise recommendations for device comparisons | Complex | 09/2025 | Planned publication date change to a later date |
| Epinephrine | Intramuscular, Subcutaneous | Solution | 207534 | Editorial Revision: Update the languageMinor Revision: Revise recommendations for device comparisons | Complex | 09/2025 | Planned publication date change to a later date |
| Estradiol | Vaginal | Tablet | 020908 | Editorial Revision: Update the languageMinor Revision: Add an in vitro BE option | Complex | Within the next 12 months | No Change |
| Ferric Derisomaltose | Intravenous | Solution | 208171 | Editorial: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidanceMinor Revision: Add in vivo BE option | Complex | 02/2026 | No Change |
| Ferric Oxyhydroxide | Injection | Injectable | 017441 | Editorial: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidance; Update the language Minor Revision: Provide more details on product characterization; Provide more details on in vitro testing | Complex | 09/2025 | Planned publication date change to a later date |
| Ferric Oxyhydroxide | Injection | Injectable | 021135 | Editorial Revision: Update the languageMinor Revision: Clarify in vitro study design | Complex | Within the next 12 months | No Change |
| Ferric Oxyhydroxide | Injection | Injectable | 020955 | Editorial: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidance; Update the language Minor Revision: Provide more details on product characterization | Complex | 09/2025 | Planned publication date change to a later date |
| Fish Oil Triglycerides | Intravenous | Emulsion | 210589 | Minor Revision: Remove recommendations on in vitro test; Provide more details on in vitro testing | Complex | 09/2025 | Planned publication date change to a later date |
| Fish Oil; Medium Chain Triglycerides; Olive Oil; Soybean Oil | Intravenous | Emulsion | 207648 | Minor Revision: Provide more details on product characterization | Complex | 09/2025 | Planned publication date change to a later date |
| Fludrocortisone Acetate | Oral | Tablet | FDA-2024-P-4514 | Minor Revision: Add additional in vivo study design (add a new higher strength approved by suitability petition) | Non-Complex | 09/2025 | Planned publication date change to a later date |
| Fluorouracil | Topical | Cream | 020985 | Minor Revision: Add an in vitro BE option | Complex | Beyond 12 months | No Change |
| Fluticasone Furoate | Inhalation | Powder | 205625 | Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE option | Complex | 08/2025 | Planned publication date change to a later date |
| Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifenatate | Inhalation | Powder | 209482 | Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE option | Complex | 08/2025 | Planned publication date change to a later date |
| Fluticasone Furoate; Vilanterol Trifenatate | Inhalation | Powder | 204275 | Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE option | Complex | 08/2025 | Planned publication date change to a later date |
| Fluticasone Propionate | Inhalation | Powder | 208798 | Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE option | Complex | 08/2025 | Planned publication date change to a later date |
| Fluticasone Propionate; Salmeterol Xinafoate | Inhalation | Powder | 208799 | Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE option | Complex | 08/2025 | Planned publication date change to a later date |
| Glatiramer Acetate | Subcutaneous | Injectable | 020622 | Minor Revision: Provide more details on product characterization | Complex | 08/2025 | Planned publication date change to a later date |
| Glucagon | Nasal | Powder | 210134 | Minor Revision: Provide more details on in vitro testing | Complex | 11/2025 | Planned publication date change to a later date |
| Glycopyrrolate | Inhalation | Powder | 207923 | Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE option | Complex | 09/2025 | Planned publication date change to a later date |
| Glycopyrrolate; Indacaterol Maleate | Inhalation | Powder | 207930 | Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE option | Complex | 09/2025 | Planned publication date change to a later date |
| Hydroxychloroquine sulfate | Oral | Tablet | 009768 | Minor Revsion: Add information on newly approved (lower or middle) strengths of the RLD/RS | Non-Complex | 09/2025 | Planned publication date change to a later date |
| Hydroxyurea | Oral | Tablet | 208843 | Minor Revision: Add BCS Class I-based biowaiver option | Non-Complex | 08/2025 | Planned publication date change to a later date |
| Indacaterol Maleate | Inhalation | Powder | 022383 | Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE option | Complex | 09/2025 | Planned publication date change to a later date |
| Ipratropium Bromide | Inhalation | Aerosol, Metered | 021527 | Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE option | Complex | 09/2025 | Planned publication date change to a later date |
| Isavuconazonium Sulfate | Oral | Capsule | 207500 | Minor Revision: Add information on newly approved (lower or middle) strengths of the RLD | Non-Complex | 08/2025 | Planned publication date change to a later date |
| Lanreotide Acetate | Subcutaneous | Solution | 022074 | Editorial Revision: Update the languageMinor Revision: Add recommendations for device comparisons | Complex | Within the next 12 months | No Change |
| Lasmiditan Succinate | Oral | Tablet | 211280 | Minor Revision: Remove recommendations on BE strength | Non-Complex | 08/2025 | Planned publication date change to a later date |
| Latanoprost | Ophthalmic | Emulsion | 206185 | Minor Revision: Clarify in vivo study design | Complex | 08/2025 | Planned publication date change to a later date |
| Levomilnacipran Hydrochloride | Oral | Capsule, extended release | 204168 | Minor Revision: Remove recommendations on in vitro test | Non-Complex | 08/2025 | Planned publication date change to a later date |
| Liraglutide | Subcutaneous | Solution | 022341 | Minor Revision: Provide more details on in vitro testing | Complex | 11/2025 | No Change |
| Liraglutide | Subcutaneous | Solution | 206321 | Minor Revision: Provide more details on in vitro testing | Complex | 11/2025 | No Change |
| Lumateperone Tosylate | Oral | Capsule | 209500 | Minor Revision: Add information on newly approved (lower or middle) strengths of the RLD | Non-Complex | 08/2025 | Planned publication date change to a later date |
| Macitentan | Oral | Tablet | 204410 | Minor Revision: Remove recommendations on REMS/ETASU | Non-Complex | 09/2025 | Planned publication date change to a later date |
| Macitentan; Tadalafil | Oral | Tablet | 218490 | Minor Revision: Remove recommendations on REMS/ETASU | Non-Complex | 09/2025 | Planned publication date change to a later date |
| Medroxyprogesterone Acetate | Injection | Injectable | 020246 | Minor Revision: Clarify in vitro study design; Provide more details on in vitro testing | Complex | 08/2025 | Planned publication date change to a later date |
| Medroxyprogesterone Acetate | Injection | Injectable | 012541 | Minor Revision: Add an in vitro BE option | Complex | 08/2025 | Planned publication date change to a later date |
| Mesalamine | Oral | Tablet, Delayed Release | 022000 | Minor Revision: Clarify in vitro study design | Complex | 11/2025 | No Change |
| Metformin Hydrochloride | Oral | For Suspension, extended release | 212595 | Minor Revision: Add an in vivo BE option | Non-Complex | 08/2025 | Planned publication date change to a later date |
| Methylprednisolone Acetate | Injection | Injectable | 011757 | Minor Revision: Clarify in vitro study design; Provide more details on in vitro testing | Complex | 08/2025 | Planned publication date change to a later date |
| Metoprolol Succinate | Oral | Capsule, extended release | 210428 | Minor Revision: Remove recommendations on in vitro test | Non-Complex | 08/2025 | Planned publication date change to a later date |
| Metronidazole | Oral | Tablet | 012623 | Minor Revison: Clarify in vivo study design | Non-Complex | 09/2025 | Planned publication date change to a later date |
| Metronidazole | Oral | Capsule | 020334 | Minor Revison: Clarify in vivo study design | Non-Complex | 09/2025 | Planned publication date change to a later date |
| Miconazole Nitrate | Vaginal | Cream 4% | 020827 | Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE option | Complex | 08/2025 | Planned publication date change to a later date |
| Miconazole Nitrate | Vaginal | Cream 2% | 017450 | Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE option | Complex | 08/2025 | Planned publication date change to a later date |
| Minocycline Hydrochloride | Dental | Powder, Extended Release | 050781 | Minor Revision: Add an in vitro BE option | Complex | 09/2025 | Planned publication date change to a later date |
| Mometasone Furoate | Inhalation | Powder | 021067 | Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE option | Complex | 09/2025 | Planned publication date change to a later date |
| Naftifine Hydrochloride | Topical | Cream 1% | 019599 | Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE option | Complex | 08/2025 | Planned publication date change to a later date |
| Naftifine Hydrochloride | Topical | Cream 2% | 019599 | Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE option | Complex | 08/2025 | Planned publication date change to a later date |
| Naftifine Hydrochloride | Topical | Gel | 204286 | Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE option | Complex | 08/2025 | Planned publication date change to a later date |
| Naftifine Hydrochloride | Topical | Gel | 019356 | Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE option | Complex | 08/2025 | Planned publication date change to a later date |
| Octreotide Acetate | Subcutaneous | Solution | 213224 | Minor Revision: Add recommendation for device comparisons | Complex | 02/2026 | No Change |
| Olive Oil; Soybean Oil | Intravenous | Emulsion | 204508 | Minor Revision: Remove recommendations on in vitro test; Provide more details on in vitro testing; Add recommendations for device comparisons | Complex | 09/2025 | Planned publication date change to a later date |
| Oxiconazole Nitrate | Topical | Cream | 019828 | Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE option | Complex | 08/2025 | Planned publication date change to a later date |
| Oxiconazole Nitrate | Topical | Lotion | 020209 | Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE option | Complex | 08/2025 | Planned publication date change to a later date |
| Palbociclib | Oral | Tablet | 212436 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 09/2025 | Planned publication date change to a later date |
| Paliperidone Palmitate | Intramuscular | Suspension, Extended Release | 207946 | Editorial Revision: Update the language to include all relevant RLD/RS within a single PSGMinor Revision: Reorganize to include all strengths within a single PSG | Complex | 08/2025 | Planned publication date change to a later date |
| Pegcetacoplan | Intravitreal | Solution | 217171 | Minor Revision: Provide more details on in vitro testing | Complex | 11/2025 | Planned publication date change to a later date |
| Pegcetacoplan | Subcutaneous | Solution | 215014 | Minor Revision: Provide more details on in vitro testing | Complex | 11/2025 | Planned publication date change to a later date |
| Penicillin G Benzathine | Injection | Injectable | 050141 | Minor Revision: Clarify in vitro study design; Provide more details on in vitro testing | Complex | 08/2025 | Planned publication date change to a later date |
| Perfluorohexyloctane | Ophthalmic | Solution | 216675 | Minor Revision: Clarify in vitro study design | Non-Complex | 11/2025 | No Change |
| Pexidartinib Hydrochloride | Oral | Capsule | 211810 | Minor Revision: Add information on newly approved (lower or middle) strengths of the RLD/RS | Non-Complex | 09/2025 | Planned publication date change to a later date |
| Phentermine Hydrochloride; Topiramate | Oral | Capsule, Extended Release | 022580 | Minor Revision: Remove recommendations on in vitro test | Non-Complex | 08/2025 | Planned publication date change to a later date |
| Ponatinib Hydrochloride | Oral | Tablet | 203469 | Minor Revision: Change in study design for in vivo BE study; Add information on newly approved (lower) strengths of the RLD/RS | Non-Complex | 08/2025 | Planned publication date change to a later date |
| Posaconazole | Oral | Suspension | 022003 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 08/2025 | Planned publication date change to a later date |
| Progesterone | Vaginal | Insert | 022057 | Editorial Revision: Update the languageMinor Revision: Remove recommendations on in vivo BE option | Complex | 08/2025 | Planned publication date change to a later date |
| Ranitidine Hydrochloride | Oral | Tablet, Effervescent | 020251; 020745 | In Vitro Major Revision: Add in vitro BE studyMinor Revision: Remove recommendation on in vivo BE study | Non-Complex | 08/2025 | Planned publication date change to a later date |
| Rifampin | Oral | Capsule | 050420 | Minor Revision: Reorganize to include all strengths within a single PSG | Non-Complex | 09/2025 | Planned publication date change to a later date |
| Risperidone | Intramuscular | Injectable | 021346 | Editorial Revision: Update the languageMinor Revision: Clarify in vivo study design | Complex | 08/2025 | Planned publication date change to a later date |
| Semaglutide | Oral | Tablet | 213051; 213182 | In Vivo Major Revision: Change in study design for in vivo BE study(ies) (to add a new higher strength)Minor Revision: Provide more detail on in vitro testing | Non-Complex | 08/2025 | Planned publication date change to a later date |
| Semaglutide | Subcutaneous | Solution | 209637 | Minor Revision: Provide more details on in vitro testing | Complex | 11/2025 | No Change |
| Semaglutide | Subcutaneous | Solution | 215256 | Minor Revision: Provide more details on in vitro testing | Complex | 11/2025 | No Change |
| Soybean Oil | Injection | Injectable | 017643; 018449; 020248; 019531; 019942 | Minor Revision: Remove recommendations on in vitro test; Provide more details on in vitro testing; Add recommendations for device comparisons | Complex | 09/2025 | Planned publication date change to a later date |
| Sparsentan | Oral | Tablet | 216403 | Minor Revision: Remove recommendations on REMS/ETASU | Non-Complex | N/A | Revision no longer planned |
| Teriparatide | Subcutaneous | Solution | 021318 | Minor Revision: Provide more details on in vitro testing | Complex | 11/2025 | No Change |
| Tirzepatide | Subcutaneous | Solution | 215866 | Minor Revision: Provide more details on in vitro testing | Complex | 11/2025 | Planned publication date change to a later date |
| Topiramate | Oral | Capsule, Extended Release | 201635 | Minor Revision: Remove recommendations on in vitro test | Non-Complex | 08/2025 | Planned publication date change to a later date |
| Topiramate | Oral | Capsule, Extended Release | 205122 | Minor Revision: Remove recommendations on in vitro test | Non-Complex | 08/2025 | Planned publication date change to a later date |
| Torsemide | Oral | Tablet | 213218 | Minor Revision: Add information on newly approved (lower or middle) strengths of the RLD/RS | Non-Complex | 08/2025 | Planned publication date change to a later date |
| Trazodone Hydrochloride | Oral | Tablet, Extended Release | 022411 | Minor Revision: Add an in vivo BE option | Non-Complex | 08/2025 | Planned publication date change to a later date |
| Triamcinolone Acetonide | Injection | Injectable | 012041, 014901 | Minor Revision: Clarify in vitro study design; Provide more details on in vitro testing | Complex | 08/2025 | Planned publication date change to a later date |
| Umeclidinium Bromide | Inhalation | Powder | 205382 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option | Complex | 08/2025 | Planned publication date change to a later date |
| Umeclidinium Bromide; Vilanterol Trifenatate | Inhalation | Powder | 203975 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option | Complex | 08/2025 | Planned publication date change to a later date |
| Valbenazine Tosylate | Oral | Capsule | 209241 | In Vitro Major Revision: Update in BCS waiver recommendation | Non-Complex | 09/2025 | Planned publication date change to a later date |
| Venlafaxine Hydrochloride | Oral | Capsule, Extended Release | 020699 | Minor Revision: Remove recommendations on in vitro test | Non-Complex | 08/2025 | Planned publication date change to a later date |
| Vosoritide | Subcutaneous | Powder | 214938 | Minor Revision: Provide more details on in vitro testing | Complex | 11/2025 | No Change |
| Zonisamide | Oral | Capsule | FDA-2018-P-0098 | Minor Revision: Add additional in vivo study design (add a new higher strength approved by suitability petition) | Non-Complex | 08/2025 | Planned publication date change to a later date |