Product-Specific Guidances for Generic Drug Development

Disclaimer: Due to April 2019 systemwide upgrades to www.fda.gov, the filenames for product-specific guidances on this web page may not match the corresponding guidance titles. In such cases, the name on the document correctly identifies the title of the guidance. These discrepancies will be corrected as soon as possible.


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 reference listed drug.

According to 21 CFR 320.24, different types of evidence may be used to establish bioequivalence for pharmaceutically equivalent drug products, including in vivo or in vitro testing, or both. The selection of the method used to demonstrate bioequivalence depends upon the purpose of the study, the analytical methods available, and the nature of the drug product. Under this regulation, applicants must conduct bioequivalence 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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (Dec. 2013).

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 describing the Agency's current thinking and expectations on how to develop generic drug products therapeutically equivalent to specific reference listed drugs.

FDA publishes these product-specific guidances 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 2017 (GDUFA II), FDA will publish guidances for reference listed drugs that are (1) new chemical entities and (2) approved on or after October 1, 2017, at least 2 years prior to the earliest lawful ANDA filing date. 1 This goal does not include complex products as defined in the GDUFA II Commitment Letter. FDA will strive to issue guidance for a complex product as soon as scientific recommendations are available.

In addition to the provided information, sponsors and investigators of any Investigational New Drug (IND)-exempt pharmacokinetic (PK) studies, pharmacodynamic (PD) studies, or bioequivalence (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 product-specific guidances 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 the regulations.gov website (https://www.regulations.gov/help). 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) for assistance regarding submissions.

The FDA posts plans for issuing new or revised product-specific guidances on the Upcoming Product-Specific Guidances for Complex Generic Drug Product Development web page.

For additional information on development of generic drug products, please refer to FDA’s biopharmaceutics guidances.

1 GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2018-2022 (GDUFA II Commitment Letter

 

 

 

Total number of currently published PSGs: 1903

Product-Specific Guidances for Specific Products Arranged by Active Ingredient


Search by Active Ingredient or by RLD or RS Number


Newly Added Guidances since June 2020

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Abiraterone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210308.pdf Draft Oral Tablet 210308 06/2020
Amoxicillin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050542.pdf Draft Oral Tablet, Chewable 050542 06/2020
Aprepitant https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209296.pdf Draft Intravenous Emulsion 209296 06/2020
Brexanolone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211371.pdf Draft Intravenous Solution 211371 06/2020
Buprenorphine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209819.pdf Draft Subcutaneous Solution, Extended Release 209819 06/2020
Desvenlafaxine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_204683.pdf Draft Oral Tablet, Extended Release 204683 06/2020
Dolutegravir Sodium; Lamivudine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211994.pdf Draft Oral Tablet 211994 06/2020
Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210649.pdf Draft Oral Tablet 210649 06/2020
Estradiol https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020472.pdf Draft Vaginal Insert, Extended Release 020472 06/2020
Fish Oil Triglycerides https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210589.pdf Draft Intravenous Emulsion 210589 06/2020
Fluorometholone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019216.pdf Draft Ophthalmic Suspension/Drops 019216 06/2020
Gilteritinib Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211349.pdf Draft Oral Tablet 211349 06/2020
Glycopyrrolate; Indacaterol Maleate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207930.pdf Draft Inhalation Powder 207930 06/2020
Ivosidenib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211192.pdf Draft Oral Tablet 211192 06/2020
Latanoprost https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_206185.pdf Draft Ophthalmic Emulsion 206185 06/2020
Metformin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212595.pdf Draft Oral For Suspension, Extended Release 212595 06/2020
Methylphenidate Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212038.pdf Draft Oral Capsule, Extended Release 212038 06/2020
Methylphenidate Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209311.pdf Draft Oral Capsule, Extended Release 209311 06/2020
Metronidazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205223.pdf Draft Vaginal Gel 205223 06/2020
Prucalopride Succinate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210166.pdf Draft Oral Tablet 210166 06/2020
Revefenacin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210598.pdf Draft Inhalation Solution 210598 06/2020
Sodium Zirconium Cyclosilicate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207078.pdf Draft Oral For Suspension 207078 06/2020
Tafenoquine Succinate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210795.pdf Draft Oral Tablet 210795 06/2020
Talazoparib Tosylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211651.pdf Draft Oral Capsule 211651 06/2020
Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209353.pdf Draft Topical Lotion 209353 06/2020
Triclabendazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208711.pdf Draft Oral Tablet 208711 06/2020

Newly Revised Guidances since June 2020

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Albendazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020666.pdf Draft Oral Tablet 020666 06/2020
Azelastine Hydrochloride; Fluticasone Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202236.PDF Draft Nasal Spray, Metered 202236 06/2020
Buprenorphine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021306.pdf Draft Transdermal Film, Extended Release 021306 06/2020
Carglumic Acid https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022562.pdf Draft Oral Tablet 022562 06/2020
Clindamycin Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050537-Sol.pdf Draft Topical Solution 050537 06/2020
Clindamycin Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050537-Swa.pdf Draft Topical Swab 050537 06/2020
Clindamycin Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050782.pdf Draft Topical Gel 050782 06/2020
Clindamycin Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050801.pdf Draft Topical Aerosol, Foam 050801 06/2020
Clindamycin Phosphate; Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050802.pdf Draft Topical Gel 050802 06/2020
Clindamycin Phosphate; Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050803.pdf Draft Topical Gel 050803 06/2020
Dapagliflozin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202293.pdf Draft Oral Tablet 202293 06/2020
Dapagliflozin; Saxagliptin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209091.pdf Draft Oral Tablet 209091 06/2020
Desvenlafaxine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_204150.pdf Draft Oral Tablet, Extended Release 204150 06/2020
Desvenlafaxine Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205583.pdf Draft Oral Tablet, Extended Release 205583 06/2020
Desvenlafaxine Succinate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021992.pdf Draft Oral Tablet, Extended Release 021992 06/2020
Dihydroergotamine Mesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020148.pdf Draft Nasal Spray, Metered 020148 06/2020
Diltiazem Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019471.pdf Draft Oral Capsule, Extended Release 019471 06/2020
Diltiazem Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020092.pdf Draft Oral Capsule, Extended Release 020092 06/2020
Diltiazem Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020062.pdf Draft Oral Capsule, Extended Release 020062 06/2020
Diltiazem Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020401.pdf Draft Oral Capsule, Extended Release 020401 06/2020
Diltiazem Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021392.pdf Draft Oral Tablet, Extended Release 021392 06/2020
Everolimus https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021560.pdf Draft Oral Tablet 021560 06/2020
Ferric Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205874.pdf Draft Oral Tablet 205874 06/2020
Fluticasone Furoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022051.pdf Draft Nasal Spray, Metered 022051 06/2020
Fluticasone Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020121.pdf Draft Nasal Spray, Metered 020121 06/2020
Fluticasone Propionate; Salmeterol Xinafoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021254.pdf Draft Inhalation Aerosol, Metered 021254 06/2020
Methylphenidate Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205831.pdf Draft Oral Capsules, Extended Release 205831 06/2020
Methylphenidate Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021284.pdf Draft Oral Capsule, Extended Release 021284 06/2020
Methylphenidate Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021259.pdf Draft Oral Capsule, Extended Release 021259 06/2020
Methylphenidate Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018029.pdf Draft Oral Tablet, Extended Release 018029 06/2020
Metoprolol Tartrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017963.pdf Draft Oral Tablet 017963 06/2020
Metronidazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020208.pdf Draft Vaginal Gel 021806 020208 06/2020
Mometasone Furoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020762.pdf Draft Nasal Spray, Metered 020762 06/2020
Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022070.pdf Draft Topical Gel 022070 06/2020
Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021108.pdf Draft Topical Cream 021108 06/2020
Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020475.pdf Draft Topical Gel 020475 06/2020
Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019963.pdf Draft Topical Cream 019963 06/2020
Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019049.pdf Draft Topical Cream 019049 06/2020
Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017955.pdf Draft Topical Gel 017955 06/2020
Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017579.pdf Draft Topical Gel 017579 06/2020
Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017522.pdf Draft Topical Cream 017522 06/2020
Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017340.pdf Draft Topical Cream 017340 06/2020
Triamcinolone Acetonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020468.pdf Draft Nasal Spray, Metered 020468 06/2020

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