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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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (August 2021).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 facilitate generic drug product availability and further assist the generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support ANDA approval, the FDA publishes product-specific guidances (PSG). PSGs describe the Agency's current thinking and expectations to develop generic drug products therapeutically equivalent to specific RLDs.

The FDA publishes PSGs to foster drug product development, ANDA submission and approval, and ultimately provide increased access to generic drugs.

PSGs 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.

The implementation of FDA's commitments under the Generic Drug User Fee Amendments Reauthorization of 20221 (GDUFA III). with regard to issuance of PSGs is effective on October 1, 2022. Under GDUFA III, the 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 two years after the date of approval, and for 75 percent of such NDA products within three 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 two years after the date of approval for 90 percent of such products.
In addition to GDUFA III PSG goals, the FDA considers several factors when prioritizing PSG development. The FDA evaluates the generic industries and other stakeholders' interest in products that do not have a PSG through controlled correspondences, public requests, and pre-ANDA meeting requests.

The FDA also evaluates drug availability and accessibility and considers public health priorities, including but not limited to, public health emergencies and drug safety and efficacy updates. In addition to these elements, the FDA continually assesses the status and outcomes of ongoing GDUFA research to ensure there are sufficient and adequate data and evidence to support the development of PSGs that align with the FDA's current scientific thinking.

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.

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: 2157

Product-Specific Guidances for Specific Products Arranged by Active Ingredient

Search by Active Ingredient or by RLD or RS Number

1 record(s) found for 'W'

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Warfarin Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Warfarin_Sodium_tab_09218_RC12-12.pdf Draft Oral Tablet 009218 12/14/2012

Newly Added Guidances since November 16, 2023

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Azacitidine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214120.pdf Draft Oral Tablet 214120 11/16/2023
Chlorhexidine Gluconate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017768.pdf Draft Topical Solution 017768 11/16/2023
Cimetidine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017920.pdf Draft Oral Tablet 017920 11/16/2023
Citalopram Hydrobromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215428.pdf Draft Oral Capsule 215428 11/16/2023
Deucravacitinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214958.pdf Draft Oral Tablet 214958 11/16/2023
Deutetrabenazine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216354.pdf Draft Oral Tablet, Extended Release 216354 11/16/2023
Dextroamphetamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215401.pdf Draft Transdermal System 215401 11/16/2023
Edaravone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215446.pdf Draft Oral Suspension 215446 11/16/2023
Ferric Pyrophosphate Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208551.pdf Draft Intravenous Powder 208551 11/16/2023
Ferric Pyrophosphate Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_206317.pdf Draft Intravenous Solution 206317 11/16/2023
Ferric Pyrophosphate Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212860.pdf Draft Intravenous Solution 212860 11/16/2023
Fingolimod Lauryl Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214962.pdf Draft Oral Tablet, Orally Disintegrating 214962 11/16/2023
Furosemide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209988.pdf Draft Subcutaneous Solution 209988 11/16/2023
Futibatinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214801.pdf Draft Oral Tablet 214801 11/16/2023
Ganaxolone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215904.pdf Draft Oral Suspension 215904 11/16/2023
Glycopyrrolate; Neostigmine Methylsulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216903.pdf Draft Intravenous Solution 216903 11/16/2023
Halobetasol Propionate; Tazarotene https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209354.pdf Draft Topical Lotion 209354 11/16/2023
Latanoprost https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216472.pdf Draft Ophthalmic Solution/Drops 216472 11/16/2023
Omidenepag Isopropyl https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215092.pdf Draft Ophthalmic Solution 215092 11/16/2023
Risperidone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210655.pdf Draft Subcutaneous For Suspension, Extended Release 210655 11/16/2023
Semaglutide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215256.pdf Draft Subcutaneous Solution 215256 11/16/2023
Tapinarof https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215272.pdf Draft Topical Cream 215272 11/16/2023

Newly Revised Guidances since November 16, 2023

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Albuterol Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020503.pdf Draft Inhalation Aerosol, Metered 020503 020983 021457 11/16/2023
Betamethasone Acetate; Betamethasone Sodium Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_014602.pdf Draft Injection Injectable 014602 11/16/2023
Budesonide; Formoterol Fumarate Dihydrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021929.pdf Draft Inhalation Aerosol, Metered 021929 11/16/2023
Clindamycin Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050600.pdf Draft Topical Lotion 050600 11/21/2023
Emtricitabine; Tenofovir Alafenamide Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208215.pdf Draft Oral Tablet 208215 11/16/2023
Ferumoxytol https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022180.pdf Draft Intravenous Solution 022180 11/16/2023
Fluticasone Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021433.pdf Draft Inhalation Aerosol, Metered 021433 11/16/2023
Fluticasone Propionate; Salmeterol Xinafoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021254.pdf Draft Inhalation Aerosol, Metered 021254 11/16/2023
Fulvestrant https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021344.pdf Draft Intramuscular Solution 021344 11/16/2023
Gabapentin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022544.pdf Draft Oral Tablet 022544 11/16/2023
Glatiramer Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020622.pdf Draft Subcutaneous Injectable 020622 11/16/2023
Inclisiran Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214012.pdf Draft Subcutaneous Solution 214012 11/21/2023
Levalbuterol Tartrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021730.pdf Draft Inhalation Aerosol, Metered 021730 11/16/2023
Mometasone Furoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205641.pdf Draft Inhalation Aerosol, Metered 205641 11/16/2023
Naltrexone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021897.pdf Draft Intramuscular For Suspension, Extended Release 021897 11/16/2023
Primidone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_009170.pdf Draft Oral Tablet 009170 11/16/2023
Ruxolitinib Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215309.pdf Draft Topical Cream 215309 11/21/2023
Semaglutide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209637.pdf Draft Subcutaneous Solution 209637 11/16/2023
Sotorasib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214665.pdf Draft Oral Tablet 214665 11/16/2023
Soybean Oil https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017643.pdf Draft Injection Injectable 017643 018449 020248 019531 019942 11/16/2023
Tiotropium Bromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021395.pdf Draft Inhalation Powder 021395 11/16/2023
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