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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (August 2021).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 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.

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

 

 

 

Total number of currently published PSGs: 1921

Product-Specific Guidances for Specific Products Arranged by Active Ingredient


Search by Active Ingredient or by RLD or RS Number


31 record(s) found for 'V'

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Valacyclovir Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Valacyclovir_HCl_tab_20487_RC-6-06.pdf Final Oral Tablet 020487 05/2008
Valbenazine tosylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Valbenazine tosylate_oral capsule_NDA 209241_RC07-18.pdf Draft Oral Capsule 209241 07/2018
Valganciclovir Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Valganciclovir hydrochloride_oral tablet_RLD 21304_RV04-16.pdf Draft Oral Tablet 021304 04/2016
Valproic Acid https://www.accessdata.fda.gov/drugsatfda_docs/psg/Valproic acid_oral capsule_RLD 018081_Final 08-17.pdf Final Oral Capsule 018081 08/2017
Valsartan https://www.accessdata.fda.gov/drugsatfda_docs/psg/Valsartan_tab_21283_RC11-06.pdf Final Oral Tablet 021283 05/2008
Vancomycin Hydrochloride:
    https://www.accessdata.fda.gov/drugsatfda_docs/psg/8510dft2_Yu_Dec152008.pdf: Draft Oral Capsule 050606 12/2008
    Vancomycin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208910.pdf Draft Oral For Solution 208910 11/2020
    Vandetanib https://www.accessdata.fda.gov/drugsatfda_docs/psg/Vandetanib_tab_022405_RC12-14.pdf Draft Oral Tablet 022405 12/2014
    Vardenafil Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Vardenafil_HCl_ODT_200179_RC03-12.pdf Draft Oral Tablets, Orally Disintegrating 200179 03/2012
    Vardenafil Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Vardenafil_HCl_tab_21400_RC4-05.pdf Final Oral Tablet 021400 05/2008
    Varenicline Tartrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Varenicline_Tartrate_tab_21928_RC11-07.pdf Draft Oral Tablet 021928 11/2010
    Vemurafenib https://www.accessdata.fda.gov/drugsatfda_docs/psg/Vemurafenib_oral tablet_RLD 202429_RC06-15.pdf Draft Oral Tablet 202429 06/2015
    Venetoclax https://www.accessdata.fda.gov/drugsatfda_docs/psg/Venetoclax_oral tablet_RLD 208573_RC03-17.pdf Draft Oral Tablet 208573 05/2017
    Venlafaxine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Venlafaxine HCl_oral tablet_RLD (20151) and 76690_RV12-16.pdf Draft Oral Tablet 020151 12/2016
    Venlafaxine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Venlafaxine_HCl_ER_tab_22104_RC2-10.pdf Draft Oral Tablet, Extended Release 022104 03/2010
    Venlafaxine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Venlafaxine_HCl_ERcap_20699_RC2-06.pdf Draft Oral Capsule, Extended Release 020699 12/2008
    Verapamil Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Verapamil_HCl_ERtab_19152_RC07-10.pdf Draft Oral Tablet, Extended Release 019152 07/2010
    Verapamil Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Verapamil_HCl_ERtab_20552_RC07-10.pdf Draft Oral Tablet, Extended Release 020552 07/2010
    Verapamil Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Verapamil_HCl_ERcap_19614_RC12-06.pdf Final Oral Capsule, Extended Release 019614 05/2008
    Verapamil Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Verapamil_HCl_ERcap_20943_RC12-06.pdf Final Oral Capsule, Extended Release 020943 05/2008
    Verapamil Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Verapamil HCl_oral tablet_ RLD 18817_Final 08-17.pdf Final Oral Tablet 018817 08/2017
    Verteporfin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Verteporfin_liposomal_inj_21119_RC04-14.pdf Draft Injection Injectable 021119 04/2014
    Vigabatrin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Vigabatrin_tablet_20427_RC03-15.pdf Draft Oral Tablet 020427 03/2015
    Vilazodone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Vilazodone_HCl_tab_22567_RC03-12.pdf Draft Oral Tablet 022567 03/2012
    Vismodegib https://www.accessdata.fda.gov/drugsatfda_docs/psg/Vismodegib_Oral capsule_203388_RC06-15.pdf Draft Oral Capsule 203388 06/2015
    Vorapaxar Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Vorapaxar sulfate_oral tablet_RLD204886_RC01-16.pdf Draft Oral Tablet 204886 01/2016
    Voriconazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Voriconazole_tab_21266_RC4-09.pdf Final Oral Tablet 021266 10/2011
    Voriconazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Voriconazole_susp_21630_RC8-06.pdf Final Oral Suspension 021630 05/2008
    Vorinostat https://www.accessdata.fda.gov/drugsatfda_docs/psg/Vorinostat_cap_21991_RC8-08.pdf Draft Oral Capsule 021991 08/2008
    Vortioxetine Hydrobromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Vortioxetine hydrobromide_Oral tablet_204447_RC06-15.pdf Draft Oral Tablet 204447 06/2015
    Voxelotor https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213137.pdf Draft Oral Tablet 213137 05/2021

    Newly Added Guidances since August 2021

    Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
    Acyclovir https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202408.pdf Draft Ophthalmic Ointment 202408 08/2021
    Albuterol Sulfate; Ipratropium Bromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021747.pdf Draft Inhalation Spray, Metered 021747 08/2021
    Amisulpride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209510.pdf Draft Intravenous Solution 209510 08/2021
    Avapritinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212608.pdf Draft Oral Tablet 212608 08/2021
    Carbinoxamine Maleate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_008915.pdf Draft Oral Tablet 008915 08/2021
    Cefiderocol Sulfate Tosylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209445.pdf Draft Intravenous Powder 209445 08/2021
    Copper Dotatate Cu-64 https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213227.pdf Draft Intravenous Solution 213227 08/2021
    Esomeprazole Magnesium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214278.pdf Draft Oral Tablet, Orally Disintegrating, Delayed Release 214278 08/2021
    Estradiol https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021166.pdf Draft Transdermal Gel, Metered 021166 08/2021
    Ethinyl Estradiol; Levonorgestrel https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_204017.pdf Draft Transdermal System 204017 08/2021
    Fostemsavir Tromethamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212950.pdf Draft Oral Tablet, Extended Release 212950 08/2021
    Indomethacin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017814.pdf Draft Rectal Suppository 017814 08/2021
    Ipratropium Bromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020393.pdf Draft Nasal Spray, Metered 020393 020394 08/2021
    Lasmiditan Succinate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211280.pdf Draft Oral Tablet 211280 08/2021
    Leuprolide Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021343.pdf Draft Subcutaneous Powder 021343 08/2021
    Loteprednol Etabonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208219.pdf Draft Ophthalmic Gel 208219 08/2021
    Olodaterol Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203108.pdf Draft Inhalation Spray, Metered 203108 08/2021
    Osilodrostat Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212801.pdf Draft Oral Tablet 212801 08/2021
    Ozanimod Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209899.pdf Draft Oral Capsule 209899 08/2021
    Paliperidone Palmitate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207946.pdf Draft Intramuscular Suspension, Extended Release 207946 08/2021
    Semaglutide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213051.pdf Draft Oral Tablet 213051 08/2021
    Sufentanil Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209128.pdf Draft Sublingual Tablet 209128 08/2021
    Tazemetostat Hydrobromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211723.pdf Draft Oral Tablet 211723 08/2021

    Newly Revised Guidances since August 2021

    Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
    Bexarotene https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021055.pdf Draft Oral Capsule 021055 08/2021
    Budesonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021324.pdf Draft Oral Capsule, Delayed Release 021324 08/2021
    Eltrombopag Olamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022291.pdf Draft Oral Tablet 022291 08/2021
    Eltrombopag Olamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207027.pdf Draft Oral For Suspension 207027 08/2021
    Ferric Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205874.pdf Draft Oral Tablet 205874 08/2021
    Ferric Oxyhydroxide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205109.pdf Draft Oral Tablet, Chewable 205109 09/2021
    Ferric Oxyhydroxide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021135.pdf Draft Intravenous Injectable 021135 09/2021
    Letrozole https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020726.pdf Draft Oral Tablet 020726 08/2021
    Leuprolide Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019732.pdf Draft Injection Injectable 019732 020011 020263 08/2021
    Leuprolide Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020517.pdf Draft Injection Injectable 020517 020708 08/2021
    Liothyronine Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_010379.pdf Draft Oral Tablet 010379 08/2021
    Loteprednol Etabonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020583.pdf Draft Ophthalmic Suspension/Drops 020583 08/2021
    Nystatin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_060578.pdf Draft Topical Powder 065203 08/2021
    Orlistat https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020766.pdf Draft Oral Capsule 020766 021887 08/2021
    Paclitaxel https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021660.pdf Draft IV Infusion For Suspension 021660 08/2021
    Podofilox https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020529.pdf Draft Topical Gel 020529 08/2021
    Sodium Zirconium Cyclosilicate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207078.pdf Draft Oral For Suspension 207078 08/2021
    Tazarotene https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021184-Cre-0.05P.pdf Draft Topical Cream 0.05% 021184 08/2021

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