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 November 17, 2022

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
AFAMELANOTIDE	SUBCUTANEOUS	IMPLANT	210797	COMPLEX	02/2023
AMOXICILLIN; CLARITHROMYCIN; VONPRAZAN FUMARATE	ORAL	CAPSULE, TABLET, TABLET	215152	NON-COMPLEX	11/2023
AMOXICILLIN; VONOPRAZAN FUMARATE	ORAL	CAPSULE, TABLET	215153	NON-COMPLEX	11/2023
ARIPIPRAZOLE	ORAL	TABLET	207202	COMPLEX	02/2023
ATROPINE SULFATE	OPHTHALMIC	SOLUTION/DROPS	213581	NON-COMPLEX	08/2023
BACLOFEN	ORAL	GRANULES	215422	NON-COMPLEX	11/2023
BELUMOSUDIL MESYLATE	ORAL	TABLET	214783	NON-COMPLEX	05/2023
BELZUTIFAN	ORAL	TABLET	215383	NON-COMPLEX	05/2023
BIMATOPROST	OPHTHALMIC	IMPLANT	211911	COMPLEX	02/2023
BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE	ORAL	TABLET, CHEWABLE, TABLET, CAPSULE	050719	COMPLEX	02/2023
CABOTEGRAVIR	INTRAMUSCULAR	SUSPENSION, EXTENDED RELEASE	215499	COMPLEX	05/2023
CABOTEGRAVIR; RILPIVIRINE	INTRAMUSCULAR	SUSPENSION, EXTENDED RELEASE	212888	COMPLEX	02/2023
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	08/2023
DARIDOREXANT HYDROCHLORIDE	ORAL	TABLET	214985	NON-COMPLEX	08/2023
DEFIBROTIDE SODIUM	INTRAVENOUS	SOLUTION	208114	COMPLEX	05/2023
DESMOPRESSIN ACETATE	NASAL	SPRAY, METERED	201656	COMPLEX	Within the next 12 months
DEXMETHYLPHENIDATE HYDROCHLORIDE;SERDEXMETHYLPHENIDATE CHLORIDE	ORAL	CAPSULE	212994	NON-COMPLEX	02/2023
DEXTROAMPHETAMINE	TRANSDERMAL	SYSTEM	215401	COMPLEX	05/2023
DIFELIKEFALIN ACETATE	INTRAVENOUS	SOLUTION	214916	NON-COMPLEX	05/2023
DIHYDROERGOTAMINE MESYLATE	NASAL	SPRAY, METERED	213436	COMPLEX	02/2023
DONEPEZIL HYDROCHLORIDE	TRANSDERMAL	SYSTEM	212304	COMPLEX	02/2023
EDARAVONE	ORAL	SUSPENSION	215446	NON-COMPLEX	08/2023
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
FEXINIDAZOLE	ORAL	TABLET	214429	NON-COMPLEX	02/2023
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
GANAXOLONE	ORAL	SUSPENSION	215904	NON-COMPLEX	08/2023
GIVOSIRAN SODIUM	SUBCUTANEOUS	SOLUTION	212194	COMPLEX	05/2023
GLUCAGON	NASAL	POWDER	210134	COMPLEX	02/2023
GOLODIRSEN	INTRAVENOUS	SOLUTION	211970	COMPLEX	02/2023
IBREXAFUNGERP CITRATE	ORAL	TABLET	214900	NON-COMPLEX	02/2023
INCLISIRAN SODIUM	SUBCUTANEOUS	SOLUTION	214012	COMPLEX	05/2023
INFIGRATINIB PHOSPHATE	ORAL	CAPSULE	214622	NON-COMPLEX	02/2023
LANREOTIDE ACETATE	SUBCUTANEOUS	SOLUTION	215395	COMPLEX	Within the next 12 months
LEUPROLIDE MESYLATE	SUBCUTANEOUS	EMULSION	211488	COMPLEX	02/2023
LEVODOPA	INHALATION	POWDER	209184	COMPLEX	11/2023
LEVONORGESTREL	INTRAUTERINE	INTRAUTERINE DEVICE	208224	COMPLEX	02/2023
LIDOCAINE; TETRACAINE	TOPICAL	PATCH	021623	COMPLEX	05/2023
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	05/2023
MARIBAVIR	ORAL	TABLET	215596	NON-COMPLEX	05/2023
MAVACAMTEN	ORAL	CAPSULE	214998	NON-COMPLEX	08/2023
MECHLORETHAMINE HYDROCHLORIDE	TOPICAL	GEL	202317	COMPLEX	02/2023
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
MOMETASONE FUROATE	IMPLANTATION	IMPLANT	209310	COMPLEX	02/2023
NALOXONE HYDROCHLORIDE	INTRAMUSCULAR, SUBCUTANEOUS	SOLUTION	215457	COMPLEX	05/2023
ODEVIXIBAT	ORAL	CAPSULE|CAPSULE, PELLETS	215498	COMPLEX	05/2023
OLANZAPINE; SAMIDORPHAN L-MALATE	ORAL	TABLET	213378	NON-COMPLEX	02/2023
OTESECONAZOLE	ORAL	CAPSULE	215888	NON-COMPLEX	08/2023
OXANDROLONE	ORAL	TABLET	013718	NON-COMPLEX	02/2023
OXYMETAZOLINE HYDROCHLORIDE	OPHTHALMIC	SOLUTION/DROPS	212520	NON-COMPLEX	11/2023
PACRITINIB CITRATE	ORAL	CAPSULE	208712	NON-COMPLEX	08/2023
PATIROMER SORBITEX CALCIUM	ORAL	POWDER	205739	COMPLEX	05/2023
PEGCETACOPLAN	SUBCUTANEOUS	SOLUTION	215014	COMPLEX	05/2023
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	TOPICAL	GEL	213478	COMPLEX	02/2023
SIROLIMUS	INTRAVENOUS	POWDER	213312	COMPLEX	05/2023
SOTORASIB	ORAL	TABLET	214665	NON-COMPLEX	02/2023
TAPINAROF	TOPICAL	CREAM	215272	COMPLEX	11/2023
TESTOSTERONE	NASAL	GEL, METERED	205488	COMPLEX	02/2023
TOBRAMYCIN	INHALATION	POWDER	201688	COMPLEX	11/2023
TRIAMCINOLONE ACETONIDE	INJECTION	SUSPENSION	211950	COMPLEX	02/2023
VENLAFAXINE BESYLATE	ORAL	TABLET, EXTENDED RELEASE	215429	NON-COMPLEX	02/2023
VILTOLARSEN	INTRAVENOUS	SOLUTION	212154	COMPLEX	02/2023
VOSORITIDE	SUBCUTANEOUS	POWDER	214938	COMPLEX	02/2023
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 November 17, 2022

Active Ingredient(s)	Route of Administration	Dosage Form	RLD or RS Application	Planned Revision Category with Description	Product Complexity	Planned Publication
AZELAIC ACID	TOPICAL	GEL	021470	Minor Revision: Add an in vitro BE option	COMPLEX	05/2023
BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	TOPICAL	GEL	050819	Editorial Revision: Update the language Minor Revision: Add an in vitro BE option	COMPLEX	02/2023
BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	TOPICAL	GEL	050741	Editorial Revision: Update the language Minor Revision: Add an in vitro BE option	COMPLEX	02/2023
BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	TOPICAL	GEL	050756	Editorial Revision: Update the language Minor Revision: Add an in vitro BE option	COMPLEX	02/2023
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	CAPSULE	016798	Minor Revision: Add an in vitro BE option; Reorganize to include all strengths within a single PSG	NON-COMPLEX	05/2023
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
HYDROXYUREA	ORAL	CAPSULE	016295	Editorial Revision: Correct typos Minor Revision: Add an in vitro BE option	NON-COMPLEX	02/2023
IVACAFTOR	ORAL	GRANULE	207925	Minor Revision: Add an in vitro BE option	NON-COMPLEX	05/2023
LANREOTIDE ACETATE	SUBCUTANEOUS	SOLUTION	022074; 215395	Editorial Revision: Update the language Minor Revision: Add recommendations for device comparisons	COMPLEX	Within the next 12 months
LEVONORGESTREL	INTRAUTERINE	INTRAUTERINE DEVICE	203159	Minor Revision: Clarify in vivo  and in vitro study designs	COMPLEX	02/2023
LIDOCAINE	TOPICAL	OINTMENT	008048; 080198	Minor Revision: Clarify in vitro study design; Add new links or references to general guidance	COMPLEX	05/2023
MIRABEGRON	ORAL	TABLET, EXTENDED RELEASE	202611	In Vitro Major Revision: Add an in vitro study	NON-COMPLEX	02/2023
NAPROXEN SODIUM	ORAL	TABLET, EXTENDED RELEASE	020353	​Editorial Revision: Update the language Minor Revision: Clarify in vivo study design	NON-COMPLEX	02/2023
PALIPERIDONE PALMITATE	INTRAMUSCULAR	SUSPENSION, EXTENDED RELEASE	022264	Minor Revision: Clarify in vivo study design	COMPLEX	05/2023
SIPONIMOD FUMARIC ACID	ORAL	TABLET	209884	Minor Revision: Add information on newly approved strength of the RLD	NON-COMPLEX	02/2023
SUCRALFATE	ORAL	SUSPENSION	019183	Minor Revision: Provide more details on in vitro testing	COMPLEX	02/2023
SUCRALFATE	ORAL	TABLET	018333	Minor Revision: Provide more details on in vitro testing	COMPLEX	02/2023