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Product-Specific Guidances for Generic Drug Development

To successfully develop and manufacture a generic drug product, an applicant should consider that their product is expected to be: pharmaceutically equivalent to its reference listed drug (RLD), i.e., to have the same active ingredient, dosage form, strength, and route of administration under the same conditions of use; bioequivalent to the RLD, i.e., to show no significant difference in the rate and extent of absorption of the active pharmaceutical ingredient; and, consequently, therapeutically equivalent, i.e., to be substitutable for the RLD with the expectation that the generic product will have the same safety and efficacy as its RLD.

According to 21 CFR 320.24, different types of evidence may be used to establish bioequivalence (BE) for pharmaceutically equivalent drug products, including in vivo or in vitro testing, or both. The selection of the method used to demonstrate BE depends upon the purpose of the study, the analytical methods available, and the nature of the drug product. Under this regulation, applicants must conduct BE testing using the most accurate, sensitive, and reproducible approach available among those set forth in 21 CFR 320.24. As the initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (August 2021).

To further facilitate generic drug product availability and to assist the generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support ANDA approval, FDA publishes product-specific guidances (PSGs) describing the Agency's current thinking and expectations on how to develop generic drug products therapeutically equivalent to specific RLD.

FDA publishes these PSGs to foster drug product development, and ANDA submission and approval, ultimately providing increased access to safe, affordable generic drugs

These guidances are published in an incremental manner and listed below in alphabetical order according to the active ingredient's name. The most recently published guidances (new and revised) are listed below.

Additionally, as part of FDA's commitments under the Generic Drug User Fee Amendments Reauthorization of 20221 (GDUFA III). FDA will issue PSGs consistent with the following goals:

  • For complex products1,2 approved in new drug applications (NDAs) on or after October 1, 2022, a PSG will be issued for 50 percent of such NDA products within 2 years after the date of approval, and for 75 percent of such NDA products within 3 years after the date of approval.
  • FDA will continue to develop PSGs for complex products approved prior to October 1, 2022, for which no PSG has been published.
  • For non-complex drug products approved in NDAs on or after October 1, 2022, that contain a new chemical entity (NCE) (as described in section 505(j)(5)(F)(ii) of the FD&C Act), a PSG will be issued within 2 years after the date of approval for 90 percent of such products.
In addition to its GDUFA III commitments, FDA will prioritize publishing of PSGs based on public health priorities, drug availability and accessibility, public requests for guidance, stakeholder interest in ANDA submission.

In addition to the provided information, sponsors and investigators of any Investigational New Drug (IND)-exempt pharmacokinetic (PK) studies, pharmacodynamic (PD) studies, or BE and/or bioavailability (BA) studies involving human subjects in support of an ANDA should refer to the current RLD labeling, including BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS sections. This information should be considered during study design and conduct; including attention to appropriate subject screening and selection, inclusion and exclusion criteria, and appropriate clinical safety monitoring.

Some of the PSGs include discussion regarding data formats. Please note that under section 745A(a) of the Federal Food, Drug, and Cosmetic Act, separate Agency-wide guidances specify the electronic formats, subject matter, and scope of applicability for certain submissions, including submissions to ANDAs. As these are finalized guidances and subject to described timetables for implementation, these guidances are binding and the electronic format(s) specified must be used for submissions to ANDAs. Questions and general information regarding the preparation of submissions in electronic format may be directed to CDER at esub@fda.hhs.gov. Questions regarding submission of datasets to CDER may be sent to edata@fda.hhs.gov.

COMMENTS: The Agency is seeking feedback and considers comments to the docket on these guidances. You may submit comments on any guidance at any time as follows: Submit electronic comments to Docket FDA-2007-D-0369. For further information on submitting electronic comments, refer to (www.regulations.gov). You may also mail your written comments to DDM (HFA-305), FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All submissions received must include the Docket No. [FDA-2007-D-0369]. Please contact the Regulations.gov Help Desk at 1-877-378-5457 (toll free) or at (www.regulations.gov/support) for assistance regarding submissions.

The FDA posts plans for issuing new or revised PSGs on the Upcoming Product-Specific Guidances for Generic Drug Product Development web page

For additional information on development of generic drug products, please refer to FDA's guidance document database.

1GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027 (GDUFA III Commitment Letter)

2Classifying Approved New Drug Products and Drug-device combination Products as Complex Products for Generic Drug Development Purposes (CDER MAPP 5240.10)

Total number of currently published PSGs: 2114

Product-Specific Guidances for Specific Products Arranged by Active Ingredient

Search by Active Ingredient or by RLD or RS Number

Newly Added Guidances since May 17, 2023

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Baloxavir Marboxil https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214410.pdf Draft Oral For Suspension 214410 05/18/2023
Belumosudil Mesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214783.pdf Draft Oral Tablet 214783 05/18/2023
Belzutifan https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215383.pdf Draft Oral Tablet 215383 05/18/2023
Bimatoprost https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211911.pdf Draft Ophthalmic Implant 211911 05/18/2023
Brincidofovir https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214460.pdf Draft Oral Suspension 214460 05/18/2023
Brincidofovir https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214461.pdf Draft Oral Tablet 214461 05/18/2023
Cabotegravir https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215499.pdf Draft Intramuscular Suspension, Extended Release 215499 05/18/2023
Casimersen https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213026.pdf Draft Intravenous Solution 213026 05/18/2023
Celecoxib; Tramadol Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213426.pdf Draft Oral Tablet 213426 05/18/2023
Citric Acid; Lactic Acid; Potassium Bitartrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208352.pdf Draft Vaginal Gel 208352 05/18/2023
Clobetasol Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213691.pdf Draft Topical Lotion 213691 05/18/2023
Defibrotide Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208114.pdf Draft Intravenous Solution 208114 05/18/2023
Difelikefalin Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214916.pdf Draft Intravenous Solution 214916 05/18/2023
Ethinyl Estradiol; Segesterone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209627.pdf Draft Vaginal Ring 209627 05/17/2023
Finerenone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215341.pdf Draft Oral Tablet 215341 05/18/2023
Givosiran Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212194.pdf Draft Subcutaneous Solution 212194 05/18/2023
Inclisiran Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214012.pdf Draft Subcutaneous Solution 214012 05/18/2023
Loxapine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022549.pdf Draft Inhalation Powder 022549 05/18/2023
Maribavir https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215596.pdf Draft Oral Tablet 215596 05/18/2023
Naloxone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215457.pdf Draft Intramuscular, Subcutaneous Solution 215457 05/18/2023
Odevixibat https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215498-Cap.pdf Draft Oral Capsule 215498 05/18/2023
Odevixibat https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215498-Cap Pellets.pdf Draft Oral Capsule, Pellets 215498 05/18/2023
Pentoxifylline https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018631.pdf Draft Oral Tablet, Extended Release 018631 05/18/2023
Piflufolastat F-18 https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214793.pdf Draft Intravenous Solution 214793 05/18/2023
Sirolimus https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213312.pdf Draft Intravenous Powder 213312 05/18/2023
Voxelotor https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216157.pdf Draft Oral Tablet, For Suspension 216157 05/18/2023

Newly Revised Guidances since May 17, 2023

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Azelastine Hydrochloride; Fluticasone Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202236.pdf Draft Nasal Spray, Metered 202236 05/18/2023
Baloxavir Marboxil https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210854.pdf Draft Oral Tablet 210854 05/18/2023
Cabozantinib S-Malate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203756.pdf Draft Oral Capsule 203756 05/18/2023
Cabozantinib S-Malate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208692.pdf Draft Oral Tablet 208692 05/18/2023
Doxepin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_016798.pdf Draft Oral Capsule 016798 05/18/2023
Fluticasone Furoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022051.pdf Draft Nasal Spray, Metered 022051 05/18/2023
Fluticasone Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020121.pdf Draft Nasal Spray, Metered 020121 05/18/2023
Formoterol Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020831.pdf Draft Inhalation Powder 020831 05/18/2023
Formoterol Fumarate; Mometasone Furoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022518.pdf Draft Inhalation Aerosol, Metered 022518 05/18/2023
Glycopyrrolate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207923.pdf Draft Inhalation Powder 207923 05/18/2023
Glycopyrrolate; Indacaterol Maleate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207930.pdf Draft Inhalation Powder 207930 05/18/2023
Indacaterol Maleate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022383.pdf Draft Inhalation Powder 022383 05/18/2023
Ivacaftor https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207925.pdf Draft Oral Granule 207925 05/18/2023
Lidocaine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_008048.pdf Draft Topical Ointment 080198 05/18/2023
Lithium Carbonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018152.pdf Draft Oral Tablet, Extended Release 076691 05/18/2023
Lithium Carbonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018027.pdf Draft Oral Tablet, Extended Release 018027 05/18/2023
Lithium Carbonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018558.pdf Draft Oral Tablet 018558 05/18/2023
Lithium Carbonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017812.pdf Draft Oral Capsule 017812 05/18/2023
Mometasone Furoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020762.pdf Draft Nasal Spray, Metered 020762 05/18/2023
Paliperidone Palmitate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022264.pdf Draft Intramuscular Suspension, Extended Release 022264 05/18/2023
Rasagiline Mesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021641.pdf Draft Oral Tablet 021641 05/18/2023
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