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, 2023

Active Ingredient(s)	Route of Administration	Dosage Form	RLD or RS Application Number	Product Complexity	Planned Publication
Adagrasib	Oral	Tablet	216340	Non-Complex	02/2024
Air Polymer-Type A	Intrauterine	Foam	212279	Complex	08/2024
Amikacin Sulfate	Inhalation	Suspension, Liposomal	207356	Complex	05/2024
Amoxicillin; Clarithromycin; Vonoprazan Fumarate	Oral	Capsule, Tablet, Tablet	215152	Non-Complex	11/2023
Amoxicillin; Vonoprazan Fumarate	Oral	Capsule, Tablet	215153	Non-Complex	11/2023
Aprepitant	Intravenous	Emulsion	216457	Complex	02/2024
Aripiprazole	Oral	Tablet	207202	Complex	Within the next 12 months
Atorvastatin Calcium	Oral	Suspension	213260	Non-Complex	05/2024
Azacitidine	Oral	Tablet	214120	Non-Complex	11/2023
Baclofen	Oral	Granules	215422	Non-Complex	02/2024
Bexagliflozin	Oral	Tablet	214373	Non-Complex	05/2024
Budesonide; Formoterol Fumarate; Glycopyrrolate	Inhalation	Aerosol, Metered	212122	Complex	02/2024
Caffeine; Ergotamine Tartrate	Rectal	Suppository	009000	Complex	02/2024
Chlorhexidine Gluconate	Topical	Solution	017768	Non-Complex	11/2023
Cimetidine	Oral	Tablet	017920	Non-Complex	11/2023
Citalopram Hydrobromide	Oral	Capsule	215428	Non-Complex	11/2023
Clobetasol Propionate	Topical	Cream	209483	Complex	Beyond 12 months
Daprodustat	Oral	Tablet	216951	Non-Complex	08/2024
Desmopressin Acetate	Nasal	Spray, Metered	201656	Complex	05/2024
Deucravacitinib	Oral	Tablet	214958	Non-Complex	11/2023
Deutetrabenazine	Oral	Tablet, Extended Release	216354	Non-Complex	11/2023
Dextroamphetamine	Transdermal	System	215401	Complex	11/2023
Edaravone	Oral	Suspension	215446	Non-Complex	11/2023
Elacestrant Dihydrochloride	Oral	Tablet	217639	Non-Complex	05/2024
Elagolix Sodium, Estradiol, Norethindrone Acetate; Elagolix Sodium	Oral	Capsule	213388	Non-Complex	02/2024
Ferric Derisomaltose	Intravenous	Solution	208171	Complex	Within the next 12 months
Ferric Pyrophosphate Citrate	Intravenous	Solution	212860	Complex	11/2023
Ferric Pyrophosphate Citrate	Intravenous	Solution	206317	Complex	11/2023
Ferric Pyrophosphate Citrate	Intravenous	For Solution	208551	Complex	11/2023
Finasteride; Tadalafil	Oral	Capsule	215423	Non-Complex	11/2023
Fingolimod Lauryl Sulfate	Oral	Tablet, Orally Disintegrating	214962	Non-Complex	11/2023
Fluticasone Propionate	Nasal	Spray, Metered	209022	Complex	Beyond 12 months
Formoterol Fumarate; Glycopyrrolate	Inhalation	Aerosol, Metered	208294	Complex	11/2023
Furosemide	Subcutaneous	Solution	209988	Complex	11/2023
Futibatinib	Oral	Tablet	214801	Non-Complex	11/2023
Ganaxolone	Oral	Suspension	215904	Non-Complex	11/2023
Ganciclovir	Ophthalmic	Gel	022211	Complex	05/2024
Glatiramer Acetate	Subcutaneous	For Solution	020622	Complex	11/2023
Glycopyrrolate; Neostigmine Methylsulfate	Intravenous	Solution	216903	Non-Complex	11/2023
Halobetasol Propionate; Tazarotene	Topical	Lotion	209354	Complex	11/2023
Lanreotide Acetate	Subcutaneous	Solution	215395	Complex	Beyond 12 months
Latanoprost	Ophthalmic	Solution/Drops	216472	Non-Complex	11/2023
Lenacapavir Sodium	Oral	Tablet	215974	Non-Complex	02/2024
Leniolisib Phosphate	Oral	Tablet	217759	Non-Complex	08/2024
Levodopa	Inhalation	Powder	209184	Complex	02/2024
Levonorgestrel	Intrauterine	Intrauterine Device	208224	Complex	Within the next 12 months
Lidocaine Hydrochloride	Ophthalmic	Gel	022221	Complex	05/2024
Lidocaine; Tetracaine	Topical	Patch	021623	Complex	Beyond 12 months
Mannitol	Inhalation	Powder	022368	Complex	11/2023
Mannitol	Inhalation	Powder	202049	Complex	11/2023
Mitomycin	Pyelocalyceal	Powder	211728	Complex	Beyond 12 months
Mometasone Furoate	Implantation	Implant	209310	Complex	02/2024
Niraparib Tosylate	Oral	Tablet	214876	Non-Complex	02/2024
Olutasidenib	Oral	Capsule	215814	Non-Complex	02/2024
Omaveloxolone	Oral	Capsule	216718	Non-Complex	08/2024
Omidenepag Isopropyl	Ophthalmic	Solution	215092	Non-Complex	11/2023
Oxazepam	Oral	Capsule	015539	Non-Complex	05/2024
Oxymetazoline Hydrochloride	Ophthalmic	Solution/Drops	212520	Non-Complex	Within the next 12 months
Patiromer Sorbitex Calcium	Oral	Powder	205739	Complex	Within the next 12 months
Pegcetacoplan	Subcutaneous	Solution	215014	Complex	Beyond 12 months
Pirtobrutinib	Oral	Tablet	216059	Non-Complex	05/2024
Risperidone	Subcutaneous	For Suspension, Extended Release	210655	Complex	11/2023
Rivaroxaban	Oral	For Suspension	215859	Non-Complex	11/2023
Semaglutide	Subcutaneous	Solution	215256	Complex	11/2023
Sodium Phenylbutyrate	Oral	For Suspension	214860	Non-Complex	02/2024
Sodium Phenylbutyrate	Oral	Pellets	216513	Non-Complex	02/2024
Sodium Phenylbutyrate; Taurursodiol	Oral	For Suspension	216660	Non-Complex	02/2024
Soybean Oil	Injection	Injectable	019942	Complex	11/2023
Sparsentan	Oral	Tablet	216403	Non-Complex	08/2024
Tapinarof	Topical	Cream	215272	Complex	11/2023
Testosterone Undecanoate	Oral	Capsule	213953	Non-Complex	02/2024
Tobramycin	Inhalation	Powder	201688	Complex	02/2024
Trofinetide	Oral	Solution	217026	Non-Complex	08/2024
Zanamivir	Inhalation	Powder	021036	Complex	11/2023

 

Planned Revised PSGs for Complex and Non-Complex
Generic Drug Products
Updated August 21, 2023

Active Ingredient(s)	Route of Administration	Dosage Form	RLD or RS Application	Planned Revision Category with Description	Product Complexity	Planned Publication
Acetaminophen; Butalbital	Oral	Capsule	088831	Minor Revision: Remove recommendation on a strength due to safety concerns	Non- Complex	02/2024
Aclidinium Bromide	Inhalation	Powder, Metered	202450	Editorial Revision: Update the language Minor Revision: Clarify in vivo and in vitro study designs; Add recommendations for device comparisons	Complex	05/2024
Aclidinium Bromide; Formoterol Fumarate	Inhalation	Powder, Metered	210595	Editorial Revision: Update the language Minor Revision: Clarify in vivo and in vitro study designs; Revise recommendations for device comparisons	Complex	05/2024
Albuterol Sulfate	Inhalation	Powder, Metered	205636	Editorial Revision: Update the language Minor Revision: Clarify in vivo and in vitro study designs; Revise recommendations for device comparisons	Complex	05/2024
Albuterol Sulfate	Inhalation	Aerosol, Metered	020503, 020983, 021457	Editorial Revision: Update the language Minor Revision: Clarify in vivo and in vitro study designs; Revise recommendations for device comparisons	Complex	11/2023
Albuterol Sulfate; Ipratropium Bromide	Inhalation	Spray, Metered	021747	Editorial Revision: Update the language Minor Revision: Clarify in vivo and in vitro study designs; Revise recommendations for device comparisons	Complex	08/2024
Azelaic Acid	Topical	Gel	021470	Minor Revision: Add an in vitro BE option	Complex	05/2024
Betamethasone Acetate; Betamethasone Sodium Phosphate	Injection	Injectable	014602	Editorial: Correct Typos Minor:  Change in study design for in vivo BE study(ies); Add an in vitro BE option	Complex	11/2023
Budesonide	Inhalation	Powder, Metered	021949	Editorial Revision: Update the language Minor Revision: Clarify in vivo and in vitro study designs; Add recommendations for device comparisons	Complex	05/2024
Budesonide; Formoterol Fumarate Dihydrate	Inhalation	Aerosol, Metered	021929	Editorial Revision: Update the language Minor Revision: Clarify in vivo and in vitro study designs; Add recommendations for device comparisons	Complex	11/2023
Doxepin Hydrochloride	Oral	Tablet	022036	Minor Revision: Reorganize to include all strengths within a single PSG; Add an in vitro BE option	Non- Complex	02/2024
Emtricitabine; Tenofovir Alafenamide Fumarate	Oral	Tablet	208215	Minor Revision: Add information on newly approved (lower or middle) strengths of the RLD	Non- Complex	11/2023
Ferric Carboxymaltose	Intravenous	Solution	203565	Minor Revision: Add information on newly approved (lower or middle) strengths of the RLD/RS	Complex	Within the next 12 months
Ferumoxytol	Intravenous	Solution	022180	Editorial Revision: Correct typos; Update the language Minor Revision: Clarify in vivo study design	Complex	Within the next 12 months
Fluorouracil	Cream	Topical	020985	Minor Revision: Add an in vitro BE option	Complex	Beyond 12 months
Fluticasone Furoate	Inhalation	Powder	205625	Editorial Revision: Update the language Minor Revision: Clarify in vivo and in vitro study designs; Add recommendations for device comparisons	Complex	02/2024
Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifenatate	Inhalation	Powder	209482	Editorial Revision: Update the language Minor Revision: Clarify in vivo and in vitro study designs; Revise recommendations for device comparisons	Complex	02/2024
Fluticasone Furoate; Vilanterol Trifenatate	Inhalation	Powder	204275	Editorial Revision: Update the language Minor Revision: Clarify in vivo and in vitro study designs; Add recommendations for device comparison	Complex	02/2024
Fluticasone Propionate	Inhalation	Aerosol, Metered	021433	Editorial Revision: Update the language Minor Revision: Clarify in vivo and in vitro study designs; Revise recommendations for device comparisons	Complex	11/2023
Fluticasone Propionate	Inhalation	Powder	020833	Editorial Revision: Update the language Minor Revision: Clarify in vivo and in vitro study designs; Revise recommendations for device comparisons	Complex	02/2024
Fluticasone Propionate	Inhalation	Powder	208798	Editorial Revision: Update the language Minor Revision: Clarify in vivo and in vitro study designs; Revise recommendations for device comparisons	Complex	05/2024
Fluticasone Propionate; Salmeterol Xinafoate	Inhalation	Aerosol, Metered	021254	Editorial Revision: Update the language Minor Revision: Clarify in vivo and in vitro study designs; Revise recommendations for device comparisons	Complex	11/2023
Fluticasone Propionate; Salmeterol Xinafoate	Inhalation	Powder	021077	Editorial Revision: Update the language Minor Revision: Clarify in vivo and in vitro study designs; Add recommendations for device comparisons	Complex	02/2024
Fluticasone Propionate; Salmeterol Xinafoate	Inhalation	Powder	208799	Editorial Revision: Update the language Minor Revision: Clarify in vivo and in vitro study designs; Revise recommendations for device comparisons	Complex	05/2024
Fulvestrant	Intramuscular	Solution	021344	Editorial Revision: Update the language Minor Revision:  Add recommendations for device comparisons	Non- Complex	11/2023
Gabapentin	Oral	Tablet	022544	In Vivo Major Revision: Add an in vivo study	Non- Complex	11/2023
Glatiramer Acetate	Subcutaneous	Injectable	020622	Editorial Revision: Update the language Minor Revision:  Add recommendations for device comparisons	Complex	11/2023
Lanreotide Acetate	Subcutaneous	Solution	022074	Editorial Revision: Update the language Minor Revision: Add recommendations for device comparisons	Complex	Beyond 12 months
Levalbuterol Tartrate	Inhalation	Aerosol, Metered	021730	Editorial Revision: Update the language Minor Revision: Clarify in vivo and in vitro study designs; Revise recommendations for device comparisons	Complex	11/2023
Levonorgestrel	Intrauterine	Intrauterine Device	203159	Minor Revision: Clarify in vivo and in vitro study designs; Add recommendations for device comparisons	Complex	Within the next 12 months
Mometasone Furoate	Inhalation	Aerosol, Metered	205641	Editorial Revision: Update the language Minor Revision: Clarify in vivo and in vitro study designs; Add recommendations for device comparisons	Complex	11/2023
Mometasone Furoate	Inhalation	Powder	021067	Editorial Revision: Update the language Minor Revision: Clarify in vivo and in vitro study designs; Revise recommendations for device comparisons	Complex	05/2024
Naltrexone	Intramuscular	For Suspension, Extended Release	021897	Editorial Revision: Correct Typos Minor Revision:  Add recommendations for device comparisons	Complex	11/2023
Olodaterol Hydrochloride	Inhalation	Spray, Metered	203108	Editorial Revision: Update the language Minor Revision: Clarify in vivo and in vitro study designs; Revise recommendations for device comparisons	Complex	08/2024
Olodaterol Hydrochloride; Tiotropium Bromide	Inhalation	Spray, Metered	206756	Editorial Revision: Update the language Minor Revision: Clarify in vivo and in vitro study designs; Revise recommendations for device comparisons	Complex	08/2024
Primidone	Oral	Tablet	009170	Minor Revision: Add information on newly approved (lower or middle) strengths of the RLD/RS	Non- Complex	11/2023
Salmeterol Xinafoate	Inhalation	Powder	020692	Editorial Revision: Update the language Minor Revision: Clarify in vivo and in vitro study designs; Revise recommendations for device comparisons	Complex	02/2024
Semaglutide	Subcutaneous	Solution	209637	Minor Revision: Add recommendations for device comparisons	Complex	11/2023
Sotorasib	Oral	Tablet	214665	In Vivo Major Revision: Change in study design for in vivo BE study(ies)	Non- Complex	11/2023
Soybean Oil	Injection	Injectable	017643; 018449; 020248	Minor Revision: Add information on newly approved (lower or middle) strengths of the RLD/RS; Add recommendations for device comparisons	Complex	11/2023
Soybean Oil	Injection	Injectable	019531	Minor Revision: Add recommendations for device comparisons	Complex	11/2024
Tiotropium Bromide	Inhalation	Powder	021395	Editorial Revision: Update the language Minor Revision: Clarify in vivo and in vitro study designs; Revise recommendations for device comparisons	Complex	11/2023
Tiotropium Bromide	Inhalation	Spray, Metered	021936	Editorial Revision: Update the language Minor Revision: Clarify in vivo and in vitro study designs; Revise recommendations for device comparisons	Complex	08/2024
Umeclidinium Bromide	Inhalation	Powder	205382	Editorial Revision: Update the language Minor Revision: Clarify in vivo and in vitro study designs; Add recommendations for device comparisons	Complex	02/2024
Umeclidinium Bromide; Vilanterol Trifenatate	Inhalation	Powder	203975	Editorial Revision: Update the language Minor Revision: Clarify in vivo and in vitro study designs; Revise recommendations for device comparisons	Complex	02/2024
Vandetanib	Oral	Tablet	022405	In Vitro Major Revision: Add an in vitro study(ies)	Non- Complex	02/2024