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: May 19, 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 | 06/2025 | Planned publication date change to a later date |
| Acroamidis Hydrochloride | Oral | Tablet | 216540 | Non-Complex | 11/2025 | Newly Added |
| Amikacin Sulfate | Inhalation | Suspension, Liposomal | 207356 | Complex | Beyond 12 months | No Change |
| Aprocitentan | Oral | Tablet | 217686 | Non-Complex | 08/2025 | No Change |
| Arimoclomol Citrate | Oral | Capsule | 214927 | Non-Complex | 11/2025 | Updated API naming to align with Orange Book |
| Aripiprazole | Oral | Tablet | 207202 | Complex | Within the next 12 months | No Change |
| Aripiprazole | Oral | Solution | 021713 | Non-Complex | 11/2025 | Newly Added |
| Berdazimer Sodium | Topical | Gel | 217424 | Complex | 08/2025 | Newly Added |
| Budesonide | Oral | Suspension | 213976 | Complex | 08/2025 | No Change |
| Bupivacaine; Meloxicam | Periarticular | Solution, Extended Release | 211988 | Complex | 06/2025 | Newly Added |
| 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 | Newly Added |
| Capivasertib | Oral | Tablet | 218197 | Non-Complex | 06/2025 | Planned publication date change to a later date |
| Carbidopa; Levodopa | Oral | Capsule, Extended Release | 217186 | Non-Complex | 08/2025 | Newly Added |
| Carbidopa; Levodopa | Oral | Tablet | 214869 | Non-Complex | 08/2025 | Newly Added |
| Cefepime Hydrochloride; Enmetazobactam | Intravenous | Powder | 216165 | Non-Complex | 11/2025 | Newly Added |
| 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 | Newly Added |
| Crinecerfont | Oral | Solution | 218820 | Non-Complex | 11/2025 | Newly Added |
| Crizotinib | Oral | Capsule, Pellets | 217581 | Non-Complex | 06/2025 | Planned publication date change to a later date |
| Danicopan | Oral | Tablet | 218037 | Non-Complex | 08/2025 | No Change |
| Dasatinib | Oral | Tablet | 216099 | Non-Complex | 08/2025 | Newly Added |
| Desmopressin Acetate | Nasal | Spray, Metered | 201656 | Complex | 11/2025 | No Change |
| Deuruxolitinib Phosphate | Oral | Tablet | 217900 | Non-Complex | 08/2025 | Newly Added |
| Deutivacaftor; Tezacaftor; Vanzacaftor Calcium | Oral | Tablet | 218730 | Non-Complex | 11/2025 | Newly Added |
| Dexamethasone | Intravitreal | Implant | 022315 | Complex | 08/2025 | Newly Added |
| Dexmedetomidine Hydrochloride | Buccal; Sublingual | Film | 215390 | Non-Complex | 06/2025 | Newly Added |
| Elafibranor | Oral | Tablet | 218860 | Non-Complex | 11/2025 | No Change |
| Eltrombopag Choline | Oral | Tablet | 216774 | Non-Complex | 08/2025 | Newly Added |
| Ensartinib Hydrochloride | Oral | Capsule | 218171 | Non-Complex | 11/2025 | Newly Added |
| Ensifentrine | Inhalation | Suspension | 217389 | Complex | 06/2025 | Planned publication date change to a later date |
| Estradiol | Vaginal | Insert | 208564 | Complex | Within the next 12 months | Newly Added |
| Estradiol; Norethindrone Acetate; Relugolix | Oral | Tablet | 214846 | Non-Complex | 11/2025 | Newly Added |
| Estradiol;Progesterone | Oral | Capsule | 210132 | Non-Complex | 11/2025 | Newly Added |
| Ezetimibe; Rosuvastatin Calcium | Oral | Tablet | 213072 | Non-Complex | 11/2025 | Newly Added |
| Fenfluramine Hydrochloride | Oral | Solution | 212102 | Non-Complex | 11/2025 | Newly Added |
| Flunisolide | Inhalation | Aerosol, Metered | 021247 | Complex | 08/2025 | No Change |
| Flurpiridaz F-18 | Intravenous | Solution | 215168 | Non-Complex | 11/2025 | Newly Added |
| Foscarbidopa; Foslevodopa | Subcutaneous | Solution | 216962 | Complex | 02/2026 | Newly Added |
| Fruquintinib | Oral | Capsule | 217564 | Non-Complex | 06/2025 | Planned publication date change to a later date |
| Givinostat Hydrochloride | Oral | Suspension | 217865 | Non-Complex | 08/2025 | No Change |
| Glucagon | Injection | Injectable | 020928 | Complex | 08/2025 | Newly Added |
| Glycopyrrolate | Oral | Tablet, Oral Disintegrating | 215019 | Non-Complex | 06/2025 | Newly Added |
| Ibrutinib | Oral | Suspension | 217003 | Non-Complex | 06/2025 | Planned publication date change to a later date |
| Imetelstat Sodium | Intravenous | Powder | 217779 | Complex | 02/2026 | Newly Added |
| Inavolisib | Oral | Tablet | 219249 | Non-Complex | 08/2025 | Newly Added |
| Iomeprol | Intra-arterial | Solution | 216016 | Non-Complex | 11/2025 | Newly Added |
| Iomeprol | Intravenous | Solution | 216017 | Non-Complex | 11/2025 | Newly Added |
| Itraconazole | Oral | Solution | 020657 | Non-Complex | 11/2025 | Newly Added |
| Ketorolac Tromethamine; Phenylephrine Hydrochloride | Irrigation | Solution | 205388 | Non-Complex | 08/2025 | Newly Added |
| Lacosamide | Oral | Solution | 022255 | Non-Complex | 11/2025 | Newly Added |
| Landiolol Hydrochloride | Intravenous | Powder | 217202 | Non-Complex | 02/2026 | Newly Added |
| Lanreotide Acetate | Subcutaneous | Solution | 215395 | Complex | Within the next 12 months | No change |
| Lazertinib Mesylate | Oral | Tablet | 219008 | Non-Complex | 08/2025 | Newly Added |
| Levacetylleucine | Oral | For Suspension | 219132 | Non-Complex | 11/2025 | Updated dosage form to align with Orange Book |
| Levamlodipine Maleate | Oral | Tablet | 212895 | Non-Complex | 11/2025 | Newly Added |
| L-Glutamine | Oral | For Solution | 208587 | Non-Complex | 11/2025 | Newly Added |
| Lidocaine; Tetracaine | Topical | Patch | 021623 | Complex | Beyond 12 months | No Change |
| Mavorixafor | Oral | Capsule | 218709 | Non-Complex | 08/2025 | Newly Added |
| Metronidazole | Oral | Suspension | 216755 | Non-Complex | 08/2025 | Newly Added |
| Minocycline Hydrochloride | Oral | Capsule, Extended Release | 219015 | Non-Complex | 08/2025 | Newly Added |
| 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 | 06/2025 | Newly Added |
| Naloxone Hydrochloride | Nasal | Spray | 215487 | Complex | 06/2025 | Planned publication date change to a later date |
| Nicotine | Oral | Inhalant | 020714 | Complex | 11/2025 | No Change |
| Nilotinib Tartrate | Oral | Tablet | 219293 | Non-Complex | 08/2025 | Newly Added |
| Nimodipine | Oral | Solution | 203340 | Non-Complex | 11/2025 | Newly Added |
| Nirogacestat Hydrobromide | Oral | Tablet | 217677 | Non-Complex | 06/2025 | Planned publication date change to a later date |
| Olezarsen Sodium | Subcutaneous | Solution | 218614 | Complex | 02/2026 | Newly Added |
| Oxaprozin | Oral | Capsule | 217927 | Non-Complex | 08/2025 | Newly Added |
| Paliperidone Palmitate | Intramuscular | Suspension, Extended Release | 216352 | Complex | 02/2026 | Newly Added |
| Palopegteriparatide | Subcutaneous | Solution | 216490 | Complex | 02/2026 | Newly Added |
| Patiromer Sorbitex Calcium | Oral | Powder | 205739 | Complex | Within the next 12 months | No Change |
| Pegulicianine Acetate | Intravenous | Powder | 214511 | Complex | 11/2025 | Newly Added |
| Pemetrexed Dipotassium | Intravenous | Powder | 210661 | Non-Complex | 06/2025 | Newly Added |
| Pivmecillinam Hydrochloride | Oral | Tablet | 216483 | Non-Complex | 08/2025 | Newly Added |
| Prednisolone Acetate | Ophthalmic | Suspension/Drops | 017100 | Complex | 06/2025 | Newly Added |
| Primidone | Oral | Orally Disintegrating Tablet | FDA-2009-P-0481 | Non-Complex | 06/2025 | Newly Added |
| Probenecid; Sulopenem Etzadroxil | Oral | Tablet | 213972 | Non-Complex | 08/2025 | Newly Added |
| Resmetirom | Oral | Tablet | 217785 | Non-Complex | 08/2025 | No Change |
| Revumenib Citrate | Oral | Tablet | 218944 | Non-Complex | 11/2025 | Newly Added |
| Roflumilast | Topical | Foam | 217242 | Complex | 11/2025 | Newly Added |
| Sacubitril; Valsartan | Oral | Capsule, Pellets | 218591 | Non-Complex | 08/2025 | Newly Added |
| Sapropterin Dihydrochloride | Oral | Powder | 205065 | Non-Complex | 06/2025 | Planned publication date change to a later date |
| Seladelpar Lysine | Oral | Capsule | 217899 | Non-Complex | 08/2025 | Newly Added |
| Selpercatinib | Oral | Tablet | 218160 | Non-Complex | 11/2025 | Newly Added |
| Sofpironium Bromide | Topical | Gel, Metered | 217347 | Complex | 06/2025 | Newly Added |
| Tenapanor Hydrochloride | Oral | Tablet | 213931 | Complex | 08/2025 | No Change |
| Teriparatide | Subcutaneous | Solution | 218771 | Complex | 11/2025 | Newly Added |
| Tirzepatide | Subcutaneous | Solution | 217806 | Complex | 08/2025 | Newly Added |
| Tovorafenib | Oral | For Suspension | 218033 | Non-Complex | 08/2025 | No Change |
| Tovorafenib | Oral | Tablet | 217700 | Non-Complex | 08/2025 | Newly Added |
| Travoprost | Intracameral | Implant | 218010 | Complex | 08/2025 | Newly Added |
| Trospium Chloride; Xanomeline Tartrate | Oral | Capsule | 216158 | Non-Complex | 08/2025 | Newly Added |
| Vadadustat | Oral | Tablet | 215192 | Non-Complex | 08/2025 | Newly Added |
| Valbenazine Tosylate | Oral | Capsule | 218390 | Non-Complex | 08/2025 | No Change |
| Valganciclovir Hydrochloride | Oral | For Solution | 022257 | Non-Complex | 11/2025 | Newly Added |
| Vonoprazan Fumarate | Oral | Tablet | 215151 | Non-Complex | 06/2025 | Newly Added |
| Vorasidenib | Oral | Tablet | 218784 | Non-Complex | 08/2025 | Newly Added |
Planned Revised PSGs for Complex and Non-Complex
Generic Drug Products
Updated: May 19, 2025
| Active Ingredient(s) | Route Of Administration | Dosage Form | RLD or RS Application Number | Planned Revision Category with Description | Product Complexity | Planned Publication | Updates |
|---|---|---|---|---|---|---|---|
| Abiraterone Acetate | Oral | Tablet | 202379 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 06/2025 | Newly Added |
| Acetaminophen; Butalbital | Oral | Capsule | 088831 | Minor Revision: Remove recommendation on a strength due to safety concerns | Non-Complex | 06/2025 | Planned publication date assigned |
| Aclidinium Bromide | Inhalation | Powder, Metered | 202450 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option | Complex | 08/2025 | No Change |
| Aclidinium Bromide; Formoterol Fumarate | Inhalation | Powder, Metered | 210595 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option | Complex | 08/2025 | No Change |
| Albuterol Sulfate | Inhalation | Powdered, Metered | 205636 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option | Complex | 06/2025 | 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 | 06/2025 | Newly Added |
| Amantadine Hydrochloride | Oral | Capsule, Extended Release | 208944 | Minor Revision: Remove recommendations on in vitro test | Non-Complex | 06/2025 | Newly Added |
| Ambrisentan | Oral | Tablet | 022081 | Minor Revision: Remove recommendations on REMS/ETASU | Non-Complex | 08/2025 | Newly Added |
| Amifampridine | Oral | Tablet | 208078 | In Vitro Major Revision: Add an in vitro study(ies) | Non-Complex | 06/2025 | Newly Added |
| 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 | 08/2025 | Newly Added |
| Amphetamine | Oral | Tablet, Orally Disintegrating, Extended Release | 204326 | Minor Revision: Clarify in vitro BE study | Non-Complex | 08/2025 | Newly Added |
| 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 | 08/2025 | Newly Added |
| Aspirin | Oral | Capsule, extended release | 200671 | Minor Revision: Remove recommendations on in vitro test | Non-Complex | 06/2025 | Newly Added |
| Azilsartan Kamedoxomil | Oral | Tablet | 200796 | Minor Revision: Clarify in vivo study design | Non-Complex | 06/2025 | Newly Added |
| Azilsartan Kamedoxomil; Chlorthalidone | Oral | Tablet | 202331 | Minor Revision: Clarify in vivo study design | Non-Complex | 06/2025 | Newly Added |
| Beclomethasone Dipropionate | Inhalation | Aerosol, Metered | 020911 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option | Complex | 08/2025 | No Change |
| Beclomethasone Dipropionate | Inhalation | Aerosol, Metered | 207921 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option | Complex | 08/2025 | No Change |
| Betamethasone Acetate; Betamethasone Sodium Phosphate | Injection | Injectable | 014602 | Minor Revision: Clarify in vitro study design; Provide more details on in vitro testing | Complex | 06/2025 | Newly Added |
| Betaxolol Hydrochloride | Ophthalmic | Suspension/Drops | 019845 | Minor Revision: Clarify in vivo study design | Complex | 06/2025 | Newly Added |
| Bosentan | Oral | Tablet | 021290 | Minor Revision: Remove recommendations on REMS/ETASU | Non-Complex | 08/2025 | Newly Added |
| Bosentan | Oral | Tablet, for Suspension | 209279 | Minor Revision: Remove recommendations on REMS/ETASU | Non-Complex | 08/2025 | Newly Added |
| Brimonidine Tartrate | Ophthalmic | Solution/Drops | 021770 | Minor Revision: Clarify in vivo study design | Non-Complex | 06/2025 | Newly Added |
| Brimonidine Tartrate | Ophthalmic | Solution/Drops | 021262 | Minor Revision: Clarify in vivo study design | Non-Complex | 06/2025 | Newly Added |
| Brimonidine Tartrate; Brinzolamide | Ophthalmic | Suspension/Drops | 204251 | Minor Revision: Clarify in vivo study design | Complex | 06/2025 | Newly Added |
| Brinzolamide | Ophthalmic | Suspension/Drops | 020816 | Minor Revision: Clarify in vivo study design | Complex | 06/2025 | Newly Added |
| Budesonide | Inhalation | Powder, Metered | 021949 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option | Complex | 08/2025 | No Change |
| Buprenorphine Hydrochloride | Buccal | Film | 207932 | Minor Revison: Clarify in vitro study design | Non-Complex | 08/2025 | Newly Added |
| Cabotegravir | Intramuscular | Suspension, Extended Release | 215499 | Minor Revision: Clarify in vivo study design | Complex | 06/2025 | Newly Added |
| Cabotegravir; Rilpivirine | Intramuscular | Suspension, Extended Release | 212888 | Minor Revision: Clarify in vivo study design | Complex | 06/2025 | Newly Added |
| Calcitonin Salmon | Injection | Injectable | 017808 | Minor Revision: Provide more details on in vitro testing | Complex | 08/2025 | Newly Added |
| Carglumic Acid | Oral | Tablet, for suspension | 022562 | In Vitro Major Revision: Add an in vitro study(ies) | Non-Complex | 06/2025 | Newly Added |
| Ciclesonide | Inhalation | Aerosol, Metered | 021658 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option | Complex | 08/2025 | No Change |
| Clevidipine | Intravenous | Emulsion | 022156 | Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances | Complex | 06/2025 | Newly Added |
| Clotrimazole | Topical | Cream | 017619 | Editorial Revision: Update the language Minor Revision: Add an in vitro BE option | Complex | 06/2025 | Newly Added |
| Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Disoproxil Fumarate | Oral | Tablet | 203100 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 06/2025 | Newly Added |
| Crofelemer | Oral | Tablet, Delayed Release | 202292 | Minor Revision: Expand the eligibility for an in vitro-based BE option | Complex | 08/2025 | Newly Added |
| Cyclobenzaprine Hydrochloride | Oral | Capsule, Extended Release | 021777 | Minor Revision: Remove recommendations on in vitro test | Non-Complex | 06/2025 | Newly Added |
| Dasiglucagon Hydrochloride | Subcutaneous | Solution | 214231 | Minor Revision: Provide more details on in vitro testing | Complex | 08/2025 | Newly Added |
| Diazepam | Oral | Tablet | 013263 | Minor Revision: Change in study design for in vivo BE study (ies) | Non-Complex | 08/2025 | Newly Added |
| Dorzolamide Hydrochloride | Ophthalmic | Solution/Drops | 020408 | Minor Revision: Clarify in vivo study design | Non-Complex | 06/2025 | Newly Added |
| Epinephrine | Intramuscular, Subcutaneous | Injectable | 020800 | Editorial Revision: Update the language Minor Revision: Revise recommendations for device comparisons | Complex | 08/2025 | Planned publication date change to a later date |
| Epinephrine | Intramuscular, Subcutaneous | Solution | 207534 | Editorial Revision: Update the language Minor Revision: Revise recommendations for device comparisons | Complex | 08/2025 | No Change |
| Estradiol | Vaginal | Tablet | 020908 | Editorial Revision: Update the language Minor Revision: Add an in vitro BE option | Complex | Within the next 12 months | Newly Added |
| Ferric Derisomaltose | Intravenous | Solution | 208171 | Editorial: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidance Minor Revision: Add in vivo BE option | Complex | 02/2026 | Newly Added |
| Fish Oil Triglycerides | Intravenous | Emulsion | 210589 | Minor Revision: Remove recommendations on in vitro test; Provide more details on in vitro testing | Complex | 08/2025 | Newly Added |
| Fish Oil; Medium Chain Triglycerides; Olive Oil; Soybean Oil | Intravenous | Emulsion | 207648 | Minor Revision: Provide more details on product characterization | Complex | 08/2025 | Newly Added |
| 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 | 08/2025 | Newly Added |
| 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 language Minor Revision: Add an in vitro and in vivo BE option | Complex | 06/2025 | Planned publication date change to a later date |
| Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifenatate | Inhalation | Powder | 209482 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option | Complex | 06/2025 | Planned publication date change to a later date |
| Fluticasone Furoate; Vilanterol Trifenatate | Inhalation | Powder | 204275 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option | Complex | 06/2025 | Planned publication date change to a later date |
| Fluticasone Propionate | Inhalation | Powder | 208798 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option | Complex | 06/2025 | Planned publication date change to a later date |
| Fluticasone Propionate; Salmeterol Xinafoate | Inhalation | Powder | 208799 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option | Complex | 06/2025 | Planned publication date change to a later date |
| Glatiramer Acetate | Subcutaneous | Injectable | 020622 | Minor Revision: Provide more details on product characterization | Complex | 06/2025 | Newly Added |
| Glucagon | Nasal | Powder | 210134 | Minor Revision: Provide more details on in vitro testing | Complex | 08/2025 | Newly Added |
| Glycopyrrolate | Inhalation | Powder | 207923 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option | Complex | 08/2025 | No Change |
| Glycopyrrolate; Indacaterol Maleate | Inhalation | Powder | 207930 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option | Complex | 08/2025 | No Change |
| Hydroxychloroquine sulfate | Oral | Tablet | 009768 | Minor Revsion: Add information on newly approved (lower or middle) strengths of the RLD/RS | Non-Complex | 08/2025 | Newly Added |
| Hydroxyurea | Oral | Tablet | 208843 | Minor Revision: Add BCS Class I-based biowaiver option | Non-Complex | 06/2025 | Planned publication date change to a later date |
| Indacaterol Maleate | Inhalation | Powder | 022383 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option | Complex | 08/2025 | No Change |
| Ipratropium Bromide | Inhalation | Aerosol, Metered | 021527 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option | Complex | 08/2025 | 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 | 08/2025 | Newly Added |
| Ferric Oxyhydroxide | Injection | Injectable | 021135 | Editorial Revision: Update the language Minor Revision: Clarify in vitro study design | Complex | Within the next 12 months | Newly Added |
| Isavuconazonium Sulfate | Oral | Capsule | 207500 | Minor Revision: Add information on newly approved (lower or middle) strengths of the RLD | Non-Complex | 06/2025 | Newly Added |
| Lanreotide Acetate | Subcutaneous | Solution | 022074 | Editorial Revision: Update the language Minor 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 | 06/2025 | Newly Added |
| Latanoprost | Ophthalmic | Emulsion | 206185 | Minor Revision: Clarify in vivo study design | Complex | 06/2025 | Newly Added |
| Levomilnacipran Hydrochloride | Oral | Capsule, extended release | 204168 | Minor Revision: Remove recommendations on in vitro test | Non-Complex | 06/2025 | Newly Added |
| Liraglutide | Subcutaneous | Solution | 022341 | Minor Revision: Provide more details on in vitro testing | Complex | 11/2025 | Newly Added |
| Liraglutide | Subcutaneous | Solution | 206321 | Minor Revision: Provide more details on in vitro testing | Complex | 11/2025 | Newly Added |
| Lumateperone Tosylate | Oral | Capsule | 209500 | Minor Revision: Add information on newly approved (lower or middle) strengths of the RLD | Non-Complex | 06/2025 | Newly Added |
| Macitentan | Oral | Tablet | 204410 | Minor Revision: Remove recommendations on REMS/ETASU | Non-Complex | 08/2025 | Newly Added |
| Macitentan; Tadalafil | Oral | Tablet | 218490 | Minor Revision: Remove recommendations on REMS/ETASU | Non-Complex | 08/2025 | Newly Added |
| Medroxyprogesterone Acetate | Injection | Injectable | 020246 | Minor Revision: Clarify in vitro study design; Provide more details on in vitro testing | Complex | 06/2025 | Newly Added |
| Medroxyprogesterone Acetate | Injection | Injectable | 012541 | Minor Revision: Add an in vitro BE option | Complex | 06/2025 | Newly Added |
| Mesalamine | Oral | Tablet, Delayed Release | 022000 | Minor Revision: Clarify in vitro study design | Complex | 11/2025 | Newly Added |
| Metformin Hydrochloride | Oral | For Suspension, extended release | 212595 | Minor Revision: Add an in vivo BE option | Non-Complex | 06/2025 | Newly Added |
| Methylprednisolone Acetate | Injection | Injectable | 011757 | Minor Revision: Clarify in vitro study design; Provide more details on in vitro testing | Complex | 06/2025 | Newly Added |
| Metoprolol Succinate | Oral | Capsule, extended release | 210428 | Minor Revision: Remove recommendations on in vitro test | Non-Complex | 06/2025 | Newly Added |
| Metronidazole | Oral | Tablet | 012623 | Minor Revison: Clarify in vivo study design | Non-Complex | 08/2025 | Newly Added |
| Metronidazole | Oral | Capsule | 020334 | Minor Revison: Clarify in vivo study design | Non-Complex | 08/2025 | Newly Added |
| Miconazole Nitrate | Vaginal | Cream 4% | 020827 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option | Complex | 06/2025 | Newly Added |
| Miconazole Nitrate | Vaginal | Cream 2% | 017450 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option | Complex | 06/2025 | Newly Added |
| Minocycline Hydrochloride | Dental | Powder, Extended Release | 050781 | Minor Revision: Add an in vitro BE option | Complex | 08/2025 | Newly Added |
| Mometasone Furoate | Inhalation | Powder | 021067 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option | Complex | 08/2025 | No Change |
| Naftifine Hydrochloride | Topical | Cream 1% | 019599 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option | Complex | 06/2025 | Newly Added |
| Naftifine Hydrochloride | Topical | Cream 2% | 019599 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option | Complex | 06/2025 | Newly Added |
| Naftifine Hydrochloride | Topical | Gel | 204286 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option | Complex | 06/2025 | Newly Added |
| Naftifine Hydrochloride | Topical | Gel | 019356 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option | Complex | 06/2025 | Newly Added |
| Octreotide Acetate | Subcutaneous | Solution | 213224 | Minor Revision: Add recommendation for device comparisons | Complex | 02/2026 | Newly Added |
| 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 | 08/2025 | Newly Added |
| Oxiconazole Nitrate | Topical | Cream | 019828 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option | Complex | 06/2025 | Newly Added |
| Oxiconazole Nitrate | Topical | Lotion | 020209 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option | Complex | 06/2025 | Newly Added |
| Palbociclib | Oral | Tablet | 212436 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 08/2025 | Newly Added |
| Paliperidone Palmitate | Intramuscular | Suspension, Extended Release | 207946 | Editorial Revision: Update the language to include all relevant RLD/RS within a single PSG Minor Revision: Reorganize to include all strengths within a single PSG | Complex | 06/2025 | Newly Added |
| Pegcetacoplan | Intravitreal | Solution | 217171 | Minor Revision: Provide more details on in vitro testing | Complex | 08/2025 | Newly Added |
| Pegcetacoplan | Subcutaneous | Solution | 215014 | Minor Revision: Provide more details on in vitro testing | Complex | 08/2025 | Newly Added |
| Penicillin G Benzathine | Injection | Injectable | 050141 | Minor Revision: Clarify in vitro study design; Provide more details on in vitro testing | Complex | 06/2025 | Newly Added |
| Perfluorohexyloctane | Ophthalmic | Solution | 216675 | Minor Revision: Clarify in vitro study design | Non-Complex | 11/2025 | Newly Added |
| Pexidartinib Hydrochloride | Oral | Capsule | 211810 | Minor Revision: Add information on newly approved (lower or middle) strengths of the RLD/RS | Non-Complex | 08/2025 | Newly Added |
| Phentermine Hydrochloride; Topiramate | Oral | Capsule, Extended Release | 022580 | Minor Revision: Remove recommendations on in vitro test | Non-Complex | 06/2025 | Newly Added |
| 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 | 06/2025 | Newly Added |
| Posaconazole | Oral | Suspension | 022003 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 06/2025 | Newly Added |
| Progesterone | Vaginal | Insert | 022057 | Editorial Revision: Update the language Minor Revision: Remove recommendations on in vivo BE option | Complex | 06/2025 | Newly Added |
| Ranitidine Hydrochloride | Oral | Tablet, Effervescent | 020251; 020745 | In Vitro Major Revision: Add in vitro BE study Minor Revision: Remove recommendation on in vivo BE study | Non-Complex | 06/2025 | Updated Planned Revision Category |
| Rifampin | Oral | Capsule | 050420 | Minor Revision: Reorganize to include all strengths within a single PSG | Non-Complex | 08/2025 | Newly Added |
| Risperidone | Intramuscular | Injectable | 021346 | Editorial Revision: Update the language Minor Revision: Clarify in vivo study design | Complex | 06/2025 | Newly Added |
| 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 | 06/2025 | Newly Added |
| Semaglutide | Subcutaneous | Solution | 209637 | Minor Revision: Provide more details on in vitro testing | Complex | 11/2025 | Newly Added |
| Semaglutide | Subcutaneous | Solution | 215256 | Minor Revision: Provide more details on in vitro testing | Complex | 11/2025 | Newly Added |
| 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 | 08/2025 | Newly Added |
| 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 | 08/2025 | Newly Added |
| Sparsentan | Oral | Tablet | 216403 | Minor Revision: Remove recommendations on REMS/ETASU | Non-Complex | 08/2025 | Newly Added |
| Teriparatide | Subcutaneous | Solution | 021318 | Minor Revision: Provide more details on in vitro testing | Complex | 11/2025 | Newly Added |
| Tirzepatide | Subcutaneous | Solution | 215866 | Minor Revision: Provide more details on in vitro testing | Complex | 08/2025 | Newly Added |
| Topiramate | Oral | Capsule, Extended Release | 201635 | Minor Revision: Remove recommendations on in vitro test | Non-Complex | 06/2025 | Newly Added |
| Topiramate | Oral | Capsule, Extended Release | 205122 | Minor Revision: Remove recommendations on in vitro test | Non-Complex | 06/2025 | Newly Added |
| Torsemide | Oral | Tablet | 213218 | Minor Revision: Add information on newly approved (lower or middle) strengths of the RLD/RS | Non-Complex | 06/2025 | Newly Added |
| Trazodone Hydrochloride | Oral | Tablet, Extended Release | 022411 | Minor Revision: Add an in vivo BE option | Non-Complex | 06/2025 | Newly Added |
| Triamcinolone Acetonide | Injection | Injectable | 012041, 014901 | Minor Revision: Clarify in vitro study design; Provide more details on in vitro testing | Complex | 06/2025 | Newly Added |
| Umeclidinium Bromide | Inhalation | Powder | 205382 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option | Complex | 06/2025 | 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 | 06/2025 | Planned publication date change to a later date |
| Valbenazine Tosylate | Oral | Capsule | 209241 | In Vitro Major Revision: Update in BCS waiver recommendation | Non-Complex | 08/2025 | Newly Added |
| Venlafaxine Hydrochloride | Oral | Capsule, Extended Release | 020699 | Minor Revision: Remove recommendations on in vitro test | Non-Complex | 06/2025 | Newly Added |
| Vosoritide | Subcutaneous | Powder | 214938 | Minor Revision: Provide more details on in vitro testing | Complex | 11/2025 | Newly Added |
| 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 | 06/2025 | Newly Added |