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 26, 2026
| Active Ingredient(s) | Route of Administration | Dosage Form | RLD or RS Application Number | Product Complexity | Planned Publication | Updates |
|---|---|---|---|---|---|---|
| Aficamten | Oral | Tablet | 219083 | Non-Complex | 02/2027 | No change |
| Amikacin Sulfate | Inhalation | Suspension, Liposomal | 207356 | Complex | Beyond 12 months | No change |
| Aripiprazole | Oral | Tablet | 207202 | Complex | Within the next 12 months | No change |
| Avatrombopag Maleate | Oral | Granule | 219696 | Non-Complex | 08/2026 | Newly added |
| Barium Sulfate | Oral | Tablet | 219840 | Complex | 11/2026 | No change |
| Benzoyl Peroxide | Topical | Cream | 214510 | Complex | 08/2026 | Newly added |
| Benzoyl Peroxide; Tretinoin | Topical | Cream | 214902 | Complex | 08/2026 | Newly added |
| Bimatoprost | Ophthalmic | Gel | 217307 | Complex | 08/2026 | Newly added |
| Bosutinib Monohydrate | Oral | Capsule | 217729 | Non-Complex | 08/2026 | Newly added |
| Brensocatib | Oral | Tablet | 217673 | Non-Complex | 08/2026 | No change |
| Bumetanide | Nasal | Spray | 219500 | Complex | 08/2026 | No change |
| Clobetasol Propionate | Topical | Cream | 209483 | Complex | Within the next 12 months | Planned publication date change to an earlier date |
| Copper | Intrauterine | System | 218201 | Complex | 11/2026 | No change |
| Copper Histidinate | Subcutaneous | Powder | 211241 | Non-Complex | 02/2027 | Newly added |
| Delgocitinib | Topical | Cream | 219155 | Complex | 11/2026 | Newly added |
| Desmopressin Acetate | Nasal | Spray, Metered | 201656 | Complex | 02/2027 | Planned publication date change to a later date |
| Dihydroergotamine Mesylate | Nasal | Powder | 217901 | Complex | 11/2026 | Planned publication date change to a later date |
| Dihydroergotamine Mesylate | Subcutaneous | Solution | 215400 | Complex | 11/2026 | No change |
| Donidalorsen Sodium | Subcutaneous | Solution | 219407 | Complex | 02/2027 | No change |
| Doxecitine; Doxribtimine | Oral | For Solution | 219792 | Non-Complex | 02/2027 | No change |
| Drospirenone | Oral | Tablet, Chewable | 216285 | Non-Complex | N/A | PSG publication no longer planned |
| Duloxetine Hydrochloride | Oral | Capsule, Delayed Rel Pellets | 219131 | Non-Complex | 08/2026 | Newly added |
| Elinzanetant | Oral | Capsule | 219469 | Non-Complex | 02/2027 | No change |
| Epinephrine | Intramuscular, Intravenous, Subcutaneous | Solution | 215425 | Non-Complex | 08/2026 | Newly added |
| Epinephrine Bitartrate | Intravenous | Solution | 218475 | Non-Complex | 08/2026 | No change |
| Estrogens, Conjugated; Medroxyprogesterone Acetate | Oral-28 | Tablet | 020527 | Complex | 11/2026 | Newly added |
| Ethinyl Estradiol; Norethindrone Acetate | Oral | Tablet, Orally Disintegrating | 218718 | Non-Complex | 02/2027 | Newly added |
| Etripamil | Nasal | Spray | 218571 | Complex | 11/2026 | Newly added |
| Ezetimibe; Rosuvastatin Calcium | Oral | Tablet | 213072 | Non-Complex | Within the next 12 months | No change |
| Fluconazole | Oral | For Suspension | 020090 | Non-Complex | 02/2027 | No change |
| Fluvoxamine Maleate | Oral | Tablet | 020243; 075888 | Non-Complex | 08/2026 | Newly added |
| Folic Acid | Oral | Solution | FDA-2024-P-0422 | Non-Complex | Within the next 12 months | Planned publication date change to a later date |
| Hydrocortisone | Oral | Granule | 213876 | Non-Complex | 08/2026 | Newly added |
| Iloprost | Inhalation | Solution | 021779 | Non-Complex | Within the next 12 months | No change |
| Imlunestrant Tosylate | Oral | Tablet | 218881 | Non-Complex | 11/2026 | No change |
| Lamotrigine | Oral | Suspension | 218879 | Non-Complex | 11/2026 | No change |
| Lanreotide Acetate | Subcutaneous | Solution | 215395 | Complex | Within the next 12 months | No change |
| Leuprolide Mesylate | Subcutaneous | Emulsion | 219745 | Complex | 02/2027 | No change |
| Levamlodipine Maleate | Oral | Tablet | 212895 | Non-Complex | Within the next 12 months | No change |
| Lidocaine | Topical | System | 215029 | Complex | 08/2026 | Newly added |
| Lidocaine; Tetracaine | Topical | Patch | 021623 | Complex | Beyond 12 months | No change |
| Lisdexamfetamine Dimesylate | Oral | Solution | 219847 | Non-Complex | 08/2026 | No change |
| Maralixibat Chloride | Oral | Tablet | 219485 | Complex | 08/2026 | Newly added |
| Meloxicam | Intravenous | Solution | 217593 | Non-Complex | 08/2026 | Newly added |
| Meloxicam | Intravenous | Solution | 218395 | Non-Complex | 08/2026 | Newly added |
| Miglustat | Oral | Capsule | 215211 | Non-Complex | 08/2026 | Newly added |
| Mitomycin | Intravesical | Powder | 215793 | Complex | 08/2026 | Newly added |
| Nafarelin Acetate | Nasal | Spray, Metered | 019886 | Complex | 02/2027 | Newly added |
| Nerandomilast | Oral | Tablet | 218764 | Non-Complex | 11/2026 | Newly added |
| Nicotine | Oral | Inhalant | 020714 | Complex | 11/2026 | Planned publication date change to a later date |
| Nimodipine | Oral | Solution | 203340 | Non-Complex | 08/2026 | No change |
| Olezarsen Sodium | Subcutaneous | Solution | 218614 | Complex | 08/2026 | No change |
| Orforglipron | Oral | Tablet | 220934 | Non-Complex | 11/2026 | Newly added |
| Paltusotine Hydrochloride | Oral | Tablet | 219070 | Non-Complex | 11/2026 | No change |
| Plozasiran Sodium | Subcutaneous | Solution | 219947 | Complex | 02/2027 | Newly added |
| Remibrutinib | Oral | Tablet | 218436 | Non-Complex | 11/2026 | No change |
| Riluzole | Oral | Film | 212640 | Non-Complex | Beyond 12 months | No change |
| Rilzabrutinib | Oral | Tablet | 219685 | Non-Complex | 08/2026 | No change |
| Rizatriptan | Oral | Film | 205394 | Non-Complex | 05/2027 | Planned publication date assigned |
| Sebetralstat | Oral | Tablet | 219301 | Non-Complex | 08/2026 | No change |
| Sepiapterin | Oral | Powder | 219666 | Non-Complex | 11/2026 | No change |
| Sevabertinib | Oral | Tablet | 219972 | Non-Complex | 02/2027 | No change |
| Sunvozertinib | Oral | Tablet | 219839 | Non-Complex | 08/2026 | No change |
| Tadalafil | Oral | Tablet, Chewable | 218527 | Non-Complex | 02/2027 | Planned publication date assigned |
| Taletrectinib Adipate | Oral | Capsule | 219713 | Non-Complex | 08/2026 | No change |
| Tradipitant | Oral | Capsule | 220152 | Non-Complex | 05/2027 | Planned publication date change to a later date |
| Treprostinil Sodium | Inhalation | Powder | 213005 | Complex | 11/2026 | Newly added |
| Vimseltinib | Oral | Capsule | 219304 | Non-Complex | 08/2026 | No change |
| Ziftomenib | Oral | Capsule | 220305 | Non-Complex | 02/2027 | No change |
| Zinc Acetate | Oral | Capsule | 020458 | Complex | Within the next 12 months | No change |
| Zolpidem Tartrate | Oral | Capsule | 215721 | Non-Complex | 11/2026 | Planned publication date change to a later date |
| Zongertinib | Oral | Tablet | 219042 | Non-Complex | 11/2026 | No change |
Planned Revised PSGs for Complex and Non-Complex
Generic Drug Products
Updated: May 26, 2026
| Active Ingredient(s) | Route Of Administration | Dosage Form | RLD or RS Application Number | Planned Revision Category with Description | Product Complexity | Planned Publication | Updates |
|---|---|---|---|---|---|---|---|
| Amphetamine | Oral | Suspension | 204325 | Minor Revision: Change in study design for in vivo BE study(ies) | Non-Complex | 08/2026 | No change |
| Amphetamine; Amphetamine Aspartate/Dextroamphetamine Sulfate | Oral | Tablet, Extended Release | 210526 | Minor Revision: Add information on newly approved (lower or middle) strengths of the RLD | Non-Complex | 08/2026 | Newly added |
| Amphetamine; Amphetamine Aspartate/Dextroamphetamine Sulfate | Oral | Suspension | 208147 | Minor Revision: Change in study design for in vivo BE study(ies) | Non-Complex | 08/2026 | No change |
| Azathioprine | Oral | Tablet | 016324 | Minor Revision: Clarify in vitro study design | Non-Complex | 08/2026 | Newly added |
| Barcitinib | Oral | Tablet | 207924 | Minor Revision: Add an in vitro BE option | Non-Complex | 08/2026 | Newly added |
| Betaxolol hydrochloride | Ophthalmic | Suspension/Drops | 019845 | Minor Revision: Add an in vitro BE option | Complex | 08/2026 | Newly added |
| Brimonidine Tartrate; Brinzolamide | Ophthalmic | Suspension/Drops | 204251 | Minor Revision: Add an in vitro BE option | Complex | 08/2026 | Newly added |
| Brinzolamide | Ophthalmic | Suspension/Drops | 020816 | Minor Revision: Add an in vitro BE option | Complex | 08/2026 | Newly added |
| Buprenorphine | Sublingual | Tablet | 020732 | Minor Revision: Add information on newly added strengths based on approved suitability petition FDA-2024-P-2909 | Non-Complex | 08/2026 | No change |
| Calcitonin Salmon | Injection | Injectable | 017808; 017769 | Minor Revision: Provide more details on product characterization | Complex | 08/2026 | No change |
| Cariprazine Hydrochloride | Oral | Capsule | 204370 | Minor Revison: Add information on newly approved (lower or middle) strengths of the RLD | Non-Complex | 08/2026 | Newly added |
| Clindamycin Phosphate | Topical | Lotion | 050600 | Minor Revision: Provide more details on product characterization Editoiral Revision: Update the language | Complex | 08/2026 | No change |
| Dasiglucagon Hydrochloride | Subcutaneous | Solution | 214231 | Minor Revision: Provide more details on product characterization | Complex | 08/2026 | No change |
| Estrogens, conjugated | Oral | Tablet | 004782 | Minor Revision: Add API sameness recommendations; Provide more details on product characterization Editorial Revison: Update the language | Complex | 02/2027 | Newly added |
| Etonogestrel | Implantation | Implant | 021529 | Minor Revision: Clarify in vitro study design | Complex | Within the next 12 months | Newly added |
| Exenatide Synthetic | Subcutaneous | Solution | 209210 | Minor Revision: Provide more details on product characterization Editoiral Revision: Update the language | Complex | 08/2026 | No change |
| Exenatide Synthetic | Subcutaneous | Solution | 022200 | Minor Revision: Provide more details on product characterization Editoiral Revision: Update the language | Complex | 08/2026 | No change |
| Ferric Carboxymaltose | Intravenous | Solution | 203565 | Minor Revision: Clarify in vivo study design Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances | Complex | 08/2026 | No change |
| Ferumoxytol | Intravenous | Solution | 022180 | Minor Revision: Clarify in vivo study design Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances | Complex | 08/2026 | No change |
| Fluorouracil | Topical | Cream | 020985 | Minor Revision: Add an in vitro BE option | Complex | Beyond 12 months | No change |
| Glimepiride | Oral | Tablet | 020496 | Minor Revision: Add information on newly approved (lower or middle) strengths of the RLD | Non-Complex | 08/2026 | Newly added |
| Glucagon | Intravenous, Subcutaneous | Solution | 212097 | Minor Revision: Provide more details on product characterization | Complex | 08/2026 | No change |
| Glucagon | Nasal | Powder | 210134 | Minor Revision: Provide more details on product characterization Editoiral Revision: Update the language | Complex | 08/2026 | No change |
| Glucagon | Injection | Injectable | 020928 | Minor Revision: Provide more details on product characterization | Complex | 08/2026 | No change |
| Hydroxyzine Pamoate | Oral | Suspension | 011795 | Minor Revision: Add an in vitro BE option | Non-Complex | 08/2026 | Newly added |
| Lanreotide Acetate | Subcutaneous | Solution | 022074 | Minor Revision: Add recommendations for device comparisons Editorial Revision: Update the language | Complex | Within the next 12 months | No change |
| Latanoprost | Ophthalmic | Emulsion | 206185 | Minor Revision: Add an in vitro BE option | Complex | 08/2026 | Newly added |
| Letermovir | Oral | Tablet | 209939 | In Vivo Major Revision: Change in study design for in vivo BE study(ies) Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances; Update the language | Non-Complex | 08/2026 | Newly added |
| Leuprolide Acetate | Subcutaneous | Powder | 021343 | Minor Revision: Add an in vitro study(ies) Editorial Revision: Update the language | Complex | 08/2026 | No change |
| Leuprolide Acetate | Subcutaneous | Powder | 021379; 021488 | Minor Revision: Add an in vitro study(ies) Editorial Revision: Update the language | Complex | 08/2026 | No change |
| Leuprolide Acetate | Subcutaneous | Powder | 021731; 213150 | Minor Revision: Add an in vitro study(ies) Editorial Revision: Update the language | Complex | 08/2026 | No change |
| Levothyroxine Sodium | Oral | Capsule | 021924 | Minor Revision: Add information on newly approved (lower or middle) strengths of the RLD | Non-Complex | 08/2026 | Newly added |
| Liraglutide | Subcutaneous | Solution | 022341 | Minor Revision: Provide more details on product characterization Editoiral Revision: Update the language | Complex | 08/2026 | No change |
| Liraglutide | Subcutaneous | Solution | 206321 | Minor Revision: Provide more details on product characterization | Complex | 08/2026 | No change |
| Lisdexamfetamine Dimesylate | Oral | Capsule | 021977 | Minor Revision: Add an in vitro BE option | Non-Complex | 08/2026 | Newly added |
| Lutetium Lu 177 Dotatate | Intravenous | Solution | 208700 | Editorial Revision: Update the language to match Orange Book | Complex | Within the next 12 months | No change |
| Maralixibat Chloride | Oral | Solution | 214662 | Minor Revision: Add information on newly approved (higher) strength | Non-Complex | 08/2026 | No change |
| Mirtazapine | Oral | Tablet | 020415 | Minor Revision: Add information on newly added strengths based on approved suitability petition FDA-2002-P-0471 Editorial Revision: Update the language | Non-Complex | 08/2026 | Newly added |
| Octreotide Acetate | Injection | Injectable | 021008 | Minor Revision: Change in study design for in vivo BE studies | Complex | 08/2026 | Newly added |
| Olaparib | Oral | Tablet | 208558 | Minor Revision: Add information on newly added strengths based on approved suitability petition FDA-2024-P-2885 | Non-Complex | 08/2026 | Newly added |
| Ondansetron | Oral | Tablet, Orally Disintegrating | 020781 | Minor Revision: Add information on newly added strengths based on approved suitability petition FDA-2004-P-0218 | Non-Complex | 08/2026 | Newly added |
| Pazopanib Hydrochloride | Oral | Tablet | 022465 | Minor Revision: Change in study design for in vivo BE study(ies) | Non-Complex | 11/2026 | No change |
| Pegcetacoplan | Intravitreal | Solution | 217171 | Minor Revision: Provide more details on product characterization Editoiral Revision: Update the language | Complex | 08/2026 | No change |
| Pegcetacoplan | Subcutaneous | Solution | 215014 | Minor Revision: Provide more details on product characterization | Complex | 08/2026 | No change |
| Pitolisant Hydrochloride | Oral | Tablet | 211150 | Minor Revision: Add an in vitro BE option | Non-Complex | 08/2026 | Newly added |
| Risperidone | Subcutaneous | Suspension, extended release | 213586 | Minor Revision: Add an in vitro BE option | Complex | 02/2027 | Newly added |
| Risperidone | Subcutaneous | For suspension, extended release | 210655 | Minor Revision: Add an in vitro BE option | Complex | 11/2026 | Newly added |
| Semaglutide | Subcutaneous | Solution | 215256 | Minor Revision: Provide more details on product characterization | Complex | 08/2026 | No change |
| Semaglutide | Subcutaneous | Solution | 209637 | Minor Revision: Provide more details on in vitro testing; Provide more details on product characterization | Complex | Within the next 12 months | No change |
| Sodium Phenylbutyrate | Oral | Powder | 020573 | In Vitro Major Revision: Add an in vitro study(ies) Minor Revision: Add recommendations for device comparisons | Non-Complex | 08/2026 | No change |
| Sodium Phenylbutyrate | Oral | For Suspension | 214860 | In Vitro Major Revision: Add an in vitro study(ies) Minor Revison: Add information on newly approved (lower or middle) strengths of the RLD | Non-Complex | 08/2026 | No change |
| Tenapanor Hydrochloride | Oral | Tablet | 211801 | Minor Revision: Add an in vitro BE option | Complex | 08/2026 | Newly added |
| Teriparatide | Subcutaneous | Solution | 021318; 218771 | Minor Revision: Provide more details on product characterization | Complex | 08/2026 | No change |
| Tirzepatide | Subcutaneous | Solution | 217806 | Minor Revision: Provide more details on product characterization Editoiral Revision: Update the language | Complex | 08/2026 | No change |
| Tirzepatide | Subcutaneous | Solution | 215866 | Minor Revision: Provide more details on product characterization Editoiral Revision: Update the language | Complex | 08/2026 | No change |
| Vosoritide | Subcutaneous | Powder | 214938 | Minor Revision: Provide more details on product characterization | Complex | 08/2026 | No change |
| Zolpidem Tartrate | Oral | Tablet, Extended Release | 021774 | Minor Revision: Clarify in vivo study design Editorial Revision: Update the language | Non-Complex | 08/2026 | Newly added |
| Zolpidem Tartrate | Sublingual | Tablet | 021997 | Minor Revision: Clarify in vivo study design Editorial Revision: Update the language | Non-Complex | 08/2026 | Newly added |
| Zolpidem Tartrate | Sublingual | Tablet | 022328 | Minor Revision: Clarify in vivo study design Editorial Revision: Update the language | Non-Complex | 08/2026 | Newly added |