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: August 21, 2026

Active Ingredient(s)	Route of Administration	Dosage Form	RLD or RS Application Number	Product Complexity	Planned Publication	Updates
Adapalene; Benzoyl Peroxide	Topical	Gel	220736	Complex	11/2026	Newly added
Aficamten	Oral	Tablet	219083	Non-Complex	11/2026	Planned publication date change to an earlier date
Amikacin Sulfate	Inhalation	Suspension, Liposomal	207356	Complex	Beyond 12 months	No change
Amlodipine Besylate	Oral	Tablet, Orally Disintegrating	022026	Non-Complex	02/2027	Newly added
Aripiprazole	Oral	Tablet	207202	Complex	Within the next 12 months	No change
Aztreonam	Inhalation	For Solution	050814	Complex	05/2027	Newly added
Barium Sulfate	Oral	Tablet	219840	Complex	11/2026	No change
Berotralstat Dihydrochloride	Oral	Pellets	219776	Non-Complex	11/2026	Newly added
Bumetanide	Nasal	Spray	219500	Complex	11/2026	Planned publication date change to a later date
Clobetasol Propionate	Topical	Cream	209483	Complex	Within the next 12 months	No change
Copper	Intrauterine	System	218201	Complex	11/2026	No change
Copper Histidinate	Subcutaneous	Powder	211241	Non-Complex	02/2027	No change
Dabigatran Etexilate Mesylate	Oral	Pellets	214358	Non-Complex	11/2026	Newly added
Delgocitinib	Topical	Cream	219155	Complex	11/2026	No change
Desmopressin Acetate	Nasal	Spray, Metered	201656	Complex	02/2027	No change
Difamilast	Topical	Ointment	219474	Complex	05/2027	Newly added
Dihydroergotamine Mesylate	Nasal	Powder	217901	Complex	11/2026	No change
Dihydroergotamine Mesylate	Subcutaneous	Solution	215400	Complex	11/2026	No change
Donidalorsen Sodium	Subcutaneous	Solution	219407	Complex	02/2027	No change
Doravirine; Islatravir	Oral	Tablet	216964	Non-Complex	02/2027	Newly added
Doxecitine; Doxribtimine	Oral	For Solution	219792	Non-Complex	02/2027	No change
Duloxetine Hydrochloride	Oral	Capsule, Delayed Rel Pellets	219131	Non-Complex	Within the next 12 months	Planned publication date change to a later date
Elinzanetant	Oral	Capsule	219469	Non-Complex	02/2027	No change
Estrogens, Conjugated; Medroxyprogesterone Acetate	Oral-28	Tablet	020527	Complex	11/2026	No change
Ethinyl Estradiol; Norethindrone Acetate	Oral	Tablet, Orally Disintegrating	218718	Non-Complex	11/2026	Planned publication date change to an earlier date
Etripamil	Nasal	Spray	218571	Complex	02/2027	Planned publication date change to a later date
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
Folic Acid	Oral	Solution	FDA-2024-P-0422	Non-Complex	Within the next 12 months	Planned publication date change to a later date
Furosemide	Subcutaneous	Solution	217294	Complex	05/2027	Newly added
Glycopyrrolate	Inhalation	Solution	208437	Complex	05/2027	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; Tetracaine	Topical	Patch	021623	Complex	Beyond 12 months	No change
Linerixibat	Oral	Tablet	220295	Complex	05/2027	Newly added
Nafarelin Acetate	Nasal	Spray, Metered	019886	Complex	02/2027	No change
Nerandomilast	Oral	Tablet	218764	Non-Complex	11/2026	No change
Nicotine	Oral	Inhalant	020714	Complex	11/2026	No change
Orforglipron	Oral	Tablet	220934	Non-Complex	11/2026	No change
Paltusotine Hydrochloride	Oral	Tablet	219070	Non-Complex	11/2026	No change
Plozasiran Sodium	Subcutaneous	Solution	219947	Complex	02/2027	No change
Remibrutinib	Oral	Tablet	218436	Non-Complex	11/2026	No change
Riluzole	Oral	Film	212640	Non-Complex	Beyond 12 months	No change
Rizatriptan	Oral	Film	205394	Non-Complex	05/2027	No change
Sepiapterin	Oral	Powder	219666	Non-Complex	11/2026	No change
Sevabertinib	Oral	Tablet	219972	Non-Complex	02/2027	No change
Tadalafil	Oral	Tablet, Chewable	218527	Non-Complex	02/2027	No change
TRADIPITANT	Oral	Capsule	220152	Non-Complex	05/2027	No change
Treprostinil	Inhalation	Solution	022387	Complex	05/2027	Newly added
Treprostinil Sodium	Inhalation	Powder	213005	Complex	11/2026	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	02/2027	Planned publication date change to a later date
Zongertinib	Oral	Tablet	219042	Non-Complex	11/2026	No change

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Planned Revised PSGs for Complex and Non-Complex
Generic Drug Products
Updated: August 21, 2026

Active Ingredient(s)	Route Of Administration	Dosage Form	RLD or RS Application Number	Planned Revision Category with Description	Product Complexity	Planned Publication	Updates
Adapalene; Benzoyl Peroxide	Topical	Gel	022320	Minor Revision: Add information on newly approved (lower or middle) strengths of the RLD	Complex	11/2026	Newly added
Albuterol Sulfate	Inhalation	Aerosol, Metered	205636	Minor Revision: Change in study design for in vivo BE study (ies)	Complex	11/2026	Newly added
Azathioprine	Oral	Tablet	016324	Minor Revision: Clarify in vitro study design	Non-Complex	11/2026	Planned publication date change to a later date
Betaxolol hydrochloride	Ophthalmic	Suspension/Drops	019845	Minor Revision: Add an in vitro BE option	Complex	11/2026	Planned publication date change to a later date
Bupropion Hydrochloride; Dextromethorphan Hydrobromide	Oral	Tablet, Extended Release	215430	Minor Revision: Add information on newly approved (lower or middle) strengths of the RLD	Non-Complex	11/2026	Newly added
Carbinoxamine Maleate	Oral	Tablet	008915	Minor Revision: Add information on newly approved (lower or middle) strengths of the RLD	Non-Complex	11/2026	Newly added
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	No change
Etonogestrel	Implantation	Implant	021529	Minor Revision: Clarify in vitro study design	Complex	Within the next 12 months	No change
Exenatide Synthetic	Subcutaneous	Solution	209210	Minor Revision: Provide more details on product characterization      Editoiral Revision: Update the language	Complex	11/2026	No change
Exenatide Synthetic	Subcutaneous	Solution	022200	Minor Revision: Provide more details on product characterization      Editoiral Revision: Update the language	Complex	11/2026	No change
Fluorouracil	Topical	Cream	020985	Minor Revision: Add an in vitro BE option	Complex	Beyond 12 months	No change
Gabapentin Enacarbil	Oral	Tablet, Extended Release	022399	Minor Revision: Change in study design for in vivo BE study (ies)	Non-Complex	11/2026	Newly added
Hydroxyzine Pamoate	Oral	Suspension	011795	Minor Revision: Add an in vitro BE option	Non-Complex	N/A	Publication no longer planned
Ixazomib Citrate	Oral	Capsule	208462	Editorial Revision: Update the language	Non-Complex	11/2026	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
Lenvatinib Mesylate	Oral	Capsule	206947	Minor Revision: Clarify in vitro study design	Non-Complex	11/2026	Newly added
Leuprolide Acetate	Injection	Injectable	019732, 020011, 020263	Minor Revision: Add recommendations for device comparisons; Provide more details on in vitro testing      Editoiral Revision: Update the language	Complex	11/2026	Newly added
Leuprolide Acetate	Injection	Injectable	020517, 020708	Minor Revision: Add recommendations for device comparisons; Provide more details on in vitro testing      Editoiral Revision: Update the language	Complex	11/2026	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
Naltrexone	Intramuscular	For Suspension, Extended Release	021897	Minor Revision: Clarify in vitro study design	Complex	11/2026	Newly added
Nitroglycerin	Oral	Inhalant	018705	Minor Revision: Add recommendations for device comparisons      Editorial Revision: Update the language	Complex	11/2026	Newly added
Pazopanib Hydrochloride	Oral	Tablet	022465	Minor Revision: Change in study design for in vivo BE study(ies)	Non-Complex	05/2027	Planned publication date change to a later date
Pyridostigmine Bromide	Oral	Tablet	009829	Editorial Revision: Remove recommendations on a strength	Non-Complex	11/2026	Newly added
Risperidone	Subcutaneous	For suspension, extended release	210655	Minor Revision: Add an in vitro BE option	Complex	02/2027	Planned publication date change to a later date
Risperidone	Subcutaneous	Suspension, Extended release	213586	Minor Revision: Add an in vitro BE option	Complex	02/2027	No change
Testosterone	Transdermal	Gel	021015	Minor Revision: Add an in vitro BE option, clarify in vivo study design      Editoiral Revision: Update the language	Complex	02/2027	Newly added
Testosterone	Transdermal	Gel, Metered	021015	Minor Revision: Add an in vitro BE option; Add recommendations for device comparisons; Clarify in vivo study design      Editoiral Revision: Update the language	Complex	02/2027	Newly added
Testosterone	Transdermal	Gel, Metered	021463	Minor Revision: Add an in vitro BE option; add recommendations for device comparisons; clarify in vivo study design      Editoiral Revision: Update the language	Complex	02/2027	Newly added
Testosterone	Transdermal	Gel	022309	Minor Revision: Add an in vitro BE option, clarify in vivo study design      Editoiral Revision: Update the language	Complex	02/2027	Newly added
Testosterone	Transdermal	Gel, Metered	022309	Minor Revision: Add an in vitro BE option; add recommendations for device comparisons; clarify in vivo study design      Editoiral Revision: Update the language	Complex	02/2027	Newly added
Testosterone	Transdermal	Gel	021454	Minor Revision: Add an in vitro BE option, clarify in vivo study design      Editoiral Revision: Update the language	Complex	02/2027	Newly added
Trifarotene	Topical	Cream	211527	Minor Revision: Add an in vitro BE option Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances; Update the language; Update the website links	Complex	11/2026	Newly added