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 February 16, 2023

Active Ingredient(s)	Route of Administration	Dosage Form	RLD or RS Application Number	Product Complexity	Planned Publication
ABROCITINIB	ORAL	TABLET	213871	NON-COMPLEX	08/2023
AMOXICILLIN; CLARITHROMYCIN; VONPRAZAN 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	08/2023
ARIPIPRAZOLE	ORAL	TABLET	207202	COMPLEX	Within the next 12 months
ASCIMINIB HYDROCHLORIDE	ORAL	TABLET	215358	NON-COMPLEX	08/2023
ATOGEPANT	ORAL	TABLET	215206	NON-COMPLEX	08/2023
ATROPINE SULFATE	OPHTHALMIC	SOLUTION/DROPS	213581	NON-COMPLEX	08/2023
AVACOPAN	ORAL	CAPSULE	214487	NON-COMPLEX	08/2023
AZACITIDINE	ORAL	TABLET	214120	NON-COMPLEX	11/2023
BACLOFEN	ORAL	GRANULES	215422	NON-COMPLEX	02/2024
BALOXAVIR MARBOXIL	ORAL	FOR SUSPENSION	214410	NON-COMPLEX	05/2023
BELUMOSUDIL MESYLATE	ORAL	TABLET	214783	NON-COMPLEX	05/2023
BELZUTIFAN	ORAL	TABLET	215383	NON-COMPLEX	05/2023
BIMATOPROST	OPHTHALMIC	IMPLANT	211911	COMPLEX	05/2023
BRINCIDOFOVIR	ORAL	TABLET	214461	NON-COMPLEX	05/2023
BRINCIDOFOVIR	ORAL	SUSPENSION	214460	NON-COMPLEX	05/2023
BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE	INHALATION	AEROSOL, METERED	212122	COMPLEX	02/2024
CABOTEGRAVIR	INTRAMUSCULAR	SUSPENSION, EXTENDED RELEASE	215499	COMPLEX	05/2023
CASIMERSEN	INTRAVENOUS	SOLUTION	213026	COMPLEX	05/2023
CELECOXIB; TRAMADOL HYDROCHLORIDE	ORAL	TABLET	213426	NON-COMPLEX	05/2023
CHLORHEXIDINE GLUCONATE	TOPICAL	SOLUTION	017768	NON-COMPLEX	11/2023
CITALOPRAM HYDROBROMIDE	ORAL	CAPSULE	215428	NON-COMPLEX	11/2023
CITRIC ACID; LACTIC ACID; POTASSIUM BITARTRATE	VAGINAL	GEL	208352	COMPLEX	05/2023
CLOBETASOL PROPIONATE	TOPICAL	CREAM	209483	COMPLEX	Beyond 12 months
CLOBETASOL PROPIONATE	TOPICAL	LOTION	213691	COMPLEX	05/2023
DARIDOREXANT HYDROCHLORIDE	ORAL	TABLET	214985	NON-COMPLEX	08/2023
DEFIBROTIDE SODIUM	INTRAVENOUS	SOLUTION	208114	COMPLEX	05/2023
DEUCRAVACITINIB	ORAL	TABLET	214958	NON-COMPLEX	11/2023
DESMOPRESSIN ACETATE	NASAL	SPRAY, METERED	201656	COMPLEX	Beyond 12 months
DEXTROAMPHETAMINE	TRANSDERMAL	SYSTEM	215401	COMPLEX	11/2023
DIFELIKEFALIN ACETATE	INTRAVENOUS	SOLUTION	214916	NON-COMPLEX	05/2023
EDARAVONE	ORAL	SUSPENSION	215446	NON-COMPLEX	11/2023
ELAGOLIX SODIUM, ESTRADIOL, NORETHINDRONE ACETATE; ELAGOLIX SODIUM	ORAL	CAPSULE	213388	NON-COMPLEX	02/2024
EPINEPHRINE	INTRAMUSCULAR, SUBCUTANEOUS	SOLUTION	201739	COMPLEX	08/2023
ETHINYL ESTRADIOL; SEGESTERONE ACETATE	VAGINAL	RING	209627	COMPLEX	Within the next 12 months
FERRIC DERISOMALTOSE	INTRAVENOUS	SOLUTION	208171	COMPLEX	11/2023
FERRIC PYROPHOSPHATE CITRATE	INTRAVENOUS	SOLUTION	212860	COMPLEX	05/2023
FERRIC PYROPHOSPHATE CITRATE	INTRAVENOUS	SOLUTION	206317	COMPLEX	08/2023
FERRIC PYROPHOSPHATE CITRATE	INTRAVENOUS	FOR SOLUTION	208551	COMPLEX	08/2023
FINERENONE	ORAL	TABLET	215341	NON-COMPLEX	05/2023
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	08/2023
FUTIBATINIB	ORAL	TABLET	214801	NON-COMPLEX	11/2023
GANAXOLONE	ORAL	SUSPENSION	215904	NON-COMPLEX	11/2023
GIVOSIRAN SODIUM	SUBCUTANEOUS	SOLUTION	212194	COMPLEX	05/2023
INCLISIRAN SODIUM	SUBCUTANEOUS	SOLUTION	214012	COMPLEX	05/2023
LANREOTIDE ACETATE	SUBCUTANEOUS	SOLUTION	215395	COMPLEX	Beyond 12 months
LEVODOPA	INHALATION	POWDER	209184	COMPLEX	11/2023
LEVONORGESTREL	INTRAUTERINE	INTRAUTERINE DEVICE	208224	COMPLEX	11/2023
LIDOCAINE; TETRACAINE	TOPICAL	PATCH	021623	COMPLEX	Beyond 12 months
LOXAPINE	INHALATION	POWDER	022549	COMPLEX	05/2023
LUMASIRAN SODIUM	SUBCUTANEOUS	SOLUTION	214103	COMPLEX	08/2023
LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN	INTRAVENOUS	SOLUTION	215833	NON-COMPLEX	08/2023
MANNITOL	INHALATION	POWDER	022368	COMPLEX	08/2023
MANNITOL	INHALATION	POWDER	202049	COMPLEX	11/2023
MARALIXIBAT CHLORIDE	ORAL	SOLUTION	214662	NON-COMPLEX	08/2023
MARIBAVIR	ORAL	TABLET	215596	NON-COMPLEX	05/2023
MAVACAMTEN	ORAL	CAPSULE	214998	NON-COMPLEX	08/2023
MIDAZOLAM HYDROCHLORIDE	INTRAMUSCULAR	SOLUTION	216359	COMPLEX	08/2023
MITAPIVAT SULFATE	ORAL	TABLET	216196	NON-COMPLEX	08/2023
MITOMYCIN	PYELOCALYCEAL	POWDER	211728	COMPLEX	Beyond 12 months
MOBOCERTINIB SUCCINATE	ORAL	CAPSULE	215310	NON-COMPLEX	08/2023
MOMETASONE FUROATE	IMPLANTATION	IMPLANT	209310	COMPLEX	08/2023
NALOXONE HYDROCHLORIDE	INTRAMUSCULAR, SUBCUTANEOUS	SOLUTION	215457	COMPLEX	05/2023
ODEVIXIBAT	ORAL	CAPSULE|CAPSULE, PELLETS	215498	COMPLEX	05/2023
OMIDENEPAG ISOPROPYL	OPHTHALMIC	SOLUTION	215092	NON-COMPLEX	11/2023
OTESECONAZOLE	ORAL	CAPSULE	215888	NON-COMPLEX	08/2023
OXANDROLONE	ORAL	TABLET	013718	NON-COMPLEX	Within the next 12 months
OXYMETAZOLINE HYDROCHLORIDE	OPHTHALMIC	SOLUTION/DROPS	212520	NON-COMPLEX	Within the next 12 months
PACRITINIB CITRATE	ORAL	CAPSULE	208712	NON-COMPLEX	08/2023
PATIROMER SORBITEX CALCIUM	ORAL	POWDER	205739	COMPLEX	Within the next 12 months
PEGCETACOPLAN	SUBCUTANEOUS	SOLUTION	215014	COMPLEX	Beyond 12 months
PENTOXIFYLLINE	ORAL	TABLET, EXTENDED RELEASE	018631	NON-COMPLEX	05/2023
PIFLUFOLASTAT F-18	INTRAVENOUS	SOLUTION	214793	NON-COMPLEX	05/2023
PILOCARPINE HYDROCHLORIDE	OPHTHALMIC	SOLUTION	214028	NON-COMPLEX	08/2023
RISPERIDONE	SUBCUTANEOUS	FOR SUSPENSION, EXTENDED RELEASE	210655	COMPLEX	11/2023
RIVAROXABAN	ORAL	FOR SUSPENSION	215859	NON-COMPLEX	11/2023
RUXOLITINIB PHOSPHATE	TOPICAL	CREAM	215309	COMPLEX	08/2023
SIROLIMUS	INTRAVENOUS	POWDER	213312	COMPLEX	05/2023
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
TAPINAROF	TOPICAL	CREAM	215272	COMPLEX	11/2023
TESTOSTERONE UNDECANOATE	ORAL	CAPSULE	213953	NON-COMPLEX	02/2024
TOBRAMYCIN	INHALATION	POWDER	201688	COMPLEX	11/2023
VOXELOTOR	ORAL	TABLET, FOR SUSPENSION	216157	NON-COMPLEX	05/2023
VUTRISIRAN	SUBCUTANEOUS	SOLUTION	215515	COMPLEX	08/2023
ZANAMIVIR	INHALATION	POWDER	021036	COMPLEX	05/2023

 

Planned Revised PSGs for Complex and Non-Complex
Generic Drug Products
Updated February 16, 2023

Active Ingredient(s)	Route of Administration	Dosage Form	RLD or RS Application	Planned Revision Category with Description	Product Complexity	Planned Publication
ALBUTEROL SULFATE	INHALATION	AEROSOL, METERED	020503, 021457, 020983	Editorial Revision: Update the language	COMPLEX	08/2023
AZELAIC ACID	TOPICAL	GEL	021470	Minor Revision: Add an in vitro BE option	COMPLEX	Beyond 12 months
AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE	NASAL	SPRAY, METERED	202236	Minor Revision: Add in vivo and in vitro BE options	COMPLEX	05/2023
BALOXAVIR MARBOXIL	ORAL	TABLET	210854	Minor Revision: Add information on newly approved strengths of the RLD	NON-COMPLEX	05/2023
BECLOMETHASONE DIPROPIONATE	INHALATION	AEROSOL, METERED	207921	Editorial Revision: Update the language	COMPLEX	08/2023
BECLOMETHASONE DIPROPIONATE	INHALATION	AEROSOL, METERED	020911	Editorial Revision: Update the language	COMPLEX	08/2023
BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE	INHALATION	AEROSOL, METERED	021929	Editorial Revision: Update the language	COMPLEX	08/2023
CABOZANTINIB S-MALATE	ORAL	TABLET	208692	Editorial Revision: Update the language Minor Revision: Change the study design for in vivo BE study (ies)	NON-COMPLEX	05/2023
CABOZANTINIB S-MALATE	ORAL	CAPSULE	203756	Editorial Revision: Update the language Minor Revision: Change the study design for in vivo BE study (ies)	NON-COMPLEX	05/2023
CICLESONIDE	INHALATION	AEROSOL, METERED	021658	Editorial Revision: Update the language	COMPLEX	08/2023
DICLOFENAC EPOLAMINE	TOPICAL	SYSTEM	021234	Editorial Revision: Update the language Minor Revision: Comply with Clinical Data Interchange Standards Consortium (CDISC); Add new links or references to general guidance	COMPLEX	08/2023
DOXEPIN HYDROCHLORIDE	ORAL	TABLET	022036	Minor Revision: Add an in vitro BE option; Reorganize to include all strengths within a single PSG	NON-COMPLEX	02/2024
DOXEPIN HYDROCHLORIDE	ORAL	CAPSULE	016798	Minor Revision: Add an in vitro BE option; Reorganize to include all strengths within a single PSG	NON-COMPLEX	05/2023
EPINEPHRINE	INHALATION	AEROSOL, METERED	205920	Editorial Revision: Update the language	COMPLEX	08/2023
FERUMOXYTOL	INTRAVENOUS	SOLUTION	022180	Editorial Revision: Correct typos; Update the language Minor Revision: Clarify in vivo study design	COMPLEX	Beyond 12 months
FLUOROURACIL	TOPICAL	CREAM	020985	Minor Revision: Add an in vitro BE option	COMPLEX	Beyond 12 months
FLUTICASONE FUROATE	NASAL	SPRAY, METERED	022051	Minor Revision: Add in vivo and in vitro BE options	COMPLEX	05/2023
FLUTICASONE PROPIONATE	NASAL	SPRAY, METERED	020121	Minor Revision: Add in vivo and in vitro BE options	COMPLEX	05/2023
FLUTICASONE PROPIONATE	INHALATION	AEROSOL, METERED	021433	Editorial Revision: Update the language	COMPLEX	08/2023
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE	INHALATION	AEROSOL, METERED	021254	Editorial Revision: Update the language	COMPLEX	08/2023
FORMOTEROL FUMARATE	INHALATION	POWDER	020831	Editorial Revision: Update the language	COMPLEX	05/2023
FORMOTEROL FUMARATE; MOMETASONE FUROATE	INHALATION	AEROSOL, METERED	022518	Editorial Revision: Update the language In Vivo Major Revision: Change in study design for in vivo BE study	COMPLEX	05/2023
FULVESTRANT	INTRAMUSCULAR	SOLUTION	021344	Editorial Revision: Update the language	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	COMPLEX	11/2023
GLUCAGON	SUBCUTANEOUS	SOLUTION	212097	Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances  Minor Revision: Add recommendations for device comparisons	COMPLEX	08/2023
GLYCOPYRROLATE	INHALATION	POWDER	207923	Editorial Revision: Update the language	COMPLEX	05/2023
GLYCOPYRROLATE; INDACATEROL MALEATE	INHALATION	POWDER	207930	Editorial Revision: Update the language	COMPLEX	05/2023
INDACATEROL MALEATE	INHALATION	POWDER	022383	Editorial Revision: Update the language	COMPLEX	05/2023
IPRATROPIUM BROMIDE	INHALATION	AEROSOL, METERED	021527	Editorial Revision: Update the language	COMPLEX	08/2023
IVACAFTOR	ORAL	GRANULE	207925	Minor Revision: Add an in vitro BE option	NON-COMPLEX	05/2023
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	COMPLEX	08/2023
LEVONORGESTREL	INTRAUTERINE	INTRAUTERINE DEVICE	203159	Minor Revision: Clarify in vivo and in vitro study designs	COMPLEX	11/2023
LIDOCAINE	TOPICAL	OINTMENT	008048; 080198	Minor Revision: Clarify in vitro study design; Add new links or references to general guidance	COMPLEX	05/2023
LITHIUM CARBONATE	ORAL	TABLET, EXTENDED RELEASE	076691	In Vivo Major Revision: Change in study design for in vivo BE study	NON-COMPLEX	05/2023
LITHIUM CARBONATE	ORAL	TABLET, EXTENDED RELEASE	018027	In Vivo Major Revision: Change in study design for in vivo BE study	NON-COMPLEX	05/2023
LITHIUM CARBONATE	ORAL	TABLET	018558	In Vivo Major Revision: Change in study design for in vivo BE study	NON-COMPLEX	05/2023
LITHIUM CARBONATE	ORAL	CAPSULE	017812	In Vivo Major Revision: Change in study design for in vivo BE study	NON-COMPLEX	05/2023
MOMETASONE FUROATE	NASAL	SPRAY, METERED	020762	Minor Revision: Add in vivo and in vitro BE options	COMPLEX	05/2023
MOMETASONE FUROATE	INHALATION	AEROSOL, METERED	205641	Editorial Revision: Update the language	COMPLEX	08/2023
NALTREXONE	INTRAMUSCULAR	FOR SUSPENSION, EXTENDED RELEASE	021897	Editorial Revision: Correct typos	COMPLEX	11/2023
PALIPERIDONE PALMITATE	INTRAMUSCULAR	SUSPENSION, EXTENDED RELEASE	022264	Minor Revision: Change in study design for in vivo BE study (ies)	COMPLEX	05/2023
RASAGILINE MESYLATE	ORAL	TABLET	021641	Minor Revision: Add an in vitro BE option	NON-COMPLEX	05/2023
SOYBEAN OIL	INJECTION	INJECTABLE	017643; 018449; 020248	Minor Revision: Add information on newly approved strengths of the RLD	COMPLEX	11/2023
VANDETANIB	ORAL	TABLET	022405	In Vitro Major Revision: Add an in vitro study (ies)	NON-COMPLEX	02/2024
VOXELOTOR	ORAL	TABLET	213137	Minor Revision: Add information on newly approved strengths of the RLD	NON-COMPLEX	02/2024