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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (August 2021).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

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

Total number of currently published PSGs: 2032

Product-Specific Guidances for Specific Products Arranged by Active Ingredient

Search by Active Ingredient or by RLD or RS Number

35 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/PSG_209241.pdf Draft Oral Capsule 209241 02/2022
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/PSG_208910.pdf Draft Oral For Solution 208910 11/2020
Vancomycin Hydrochloride:
    https://www.accessdata.fda.gov/drugsatfda_docs/psg/8510dft2_Yu_Dec152008.pdf: Draft Oral Capsule 050606 12/2008
    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 Tablet, 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
    Vasopressin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_204485.pdf Draft Intravenous Solution 204485 02/2022
    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_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_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_oral tablet_ RLD 18817_Final 08-17.pdf Final Oral Tablet 018817 08/2017
    Vericiguat https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214377.pdf Draft Oral Tablet 214377 08/2022
    Verteporfin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Verteporfin_liposomal_inj_21119_RC04-14.pdf Draft Injection Injectable 021119 04/2014
    Vibegron https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213006.pdf Draft Oral Tablet 213006 08/2022
    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
    Viloxazine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211964.pdf Draft Oral Capsule, Extended Release 211964 02/2022
    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 2022

    Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
    Acetaminophen; Ibuprofen https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211733.pdf Draft Oral Tablet 211733 08/2022
    Amphetamine; Amphetamine Aspartate/Dextroamphetamine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210526.pdf Draft Oral Tablet, Extended Release 210526 08/2022
    Ampicillin/Ampicillin Trihydrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_064082.pdf Draft Oral Capsule 064082 08/2022
    Azelastine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213872.pdf Draft Nasal Spray, Metered 213872 08/2022
    Berotralstat Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214094.pdf Draft Oral Capsule 214094 08/2022
    Cabotegravir Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212887.pdf Draft Oral Tablet 212887 08/2022
    Carbamazepine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018281.pdf Draft Oral Tablet, Chewable 018281 08/2022
    Caspofungin Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021227.pdf Draft Intravenous Powder 021227 08/2022
    Cobicistat; Darunavir; Emtricitabine; Tenofovir Alafenamide Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210455.pdf Draft Oral Tablet 210455 08/2022
    Cyclosporine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214965.pdf Draft Ophthalmic Emulsion 214965 08/2022
    Cytarabine; Daunorubicin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209401.pdf Draft Intravenous Powder 209401 08/2022
    Dasiglucagon Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214231.pdf Draft Subcutaneous Solution 214231 08/2022
    Doxycycline Hyclate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050751.pdf Draft Periodontal System, Extended Release 050751 08/2022
    Etonogestrel https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021529.pdf Draft Implantation Implant 021529 08/2022
    Famotidine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020801.pdf Draft Oral Tablet, Chewable 020801 08/2022
    Gallium Ga-68 Gozetotide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212642.pdf Draft Intravenous Solution 212642 212643 08/2022
    Ibuprofen https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020601.pdf Draft Oral Tablet, Chewable 020601 08/2022
    Ketoprofen https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018754.pdf Draft Oral Capsule 018754 08/2022
    Lonafarnib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213969.pdf Draft Oral Capsule 213969 08/2022
    Loperamide Hydrochloride; Simethicone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020606.pdf Draft Oral Tablet, Chewable 020606 08/2022
    Loteprednol Etabonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210933.pdf Draft Ophthalmic Suspension/Drops 210933 08/2022
    Mometasone Furoate; Olopatadine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211746.pdf Draft Nasal Spray, Metered 211746 08/2022
    Nifurtimox https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213464.pdf Draft Oral Tablet 213464 08/2022
    Pafolacianine Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214907.pdf Draft Intravenous Solution 214907 08/2022
    Relugolix https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214621.pdf Draft Oral Tablet 214621 08/2022
    Setmelanotide Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213793.pdf Draft Subcutaneous Solution 213793 08/2022
    Technetium Tc-99m Sodium Pertechnetate Generator https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202158.pdf Draft Intravenous, Intravesicular, Ophthalmic Solution 202158 08/2022
    Vericiguat https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214377.pdf Draft Oral Tablet 214377 08/2022
    Vibegron https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213006.pdf Draft Oral Tablet 213006 08/2022

    Newly Revised Guidances since August 2022

    Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
    Amoxicillin; Clavulanate Potassium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050726.pdf Draft Oral Tablet, Chewable 050726 08/2022
    Azelastine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020114.pdf Draft Nasal Spray, Metered 020114 08/2022
    Cetirizine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021621.pdf Draft Oral Tablet, Chewable 021621 08/2022
    Dantrolene Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205579.pdf Draft Intravenous For Suspension 205579 08/2022
    Ethinyl Estradiol; Norethindrone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021490.pdf Draft Oral Tablet 021490 202086 08/2022
    Ethinyl Estradiol; Norethindrone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203667.pdf Draft Oral Tablet 203667 08/2022
    Lamotrigine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020764.pdf Draft Oral Tablet, For Suspension 020764 08/2022
    Lanthanum Carbonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021468.pdf Draft Oral Tablet, Chewable 021468 08/2022
    Loratadine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021891.pdf Draft Oral Tablet, Chewable 021891 08/2022
    Medroxyprogesterone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_012541.pdf Draft Injection Injectable 012541 08/2022
    Medroxyprogesterone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020246.pdf Draft Injection Injectable 020246 08/2022
    Meloxicam https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210583.pdf Draft Intravenous Solution 210583 08/2022
    Methylphenidate Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021475.pdf Draft Oral Tablet, Chewable 021475 08/2022
    Nicotine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020385.pdf Draft Nasal Spray, Metered 020385 08/2022
    Olopatadine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021861.pdf Draft Nasal Spray, Metered 021861 08/2022
    Oxymetazoline Hydrochloride; Tetracaine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208032.pdf Draft Nasal Spray, Metered 208032 08/2022
    Prednisone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202020.pdf Draft Oral Tablet, Delayed Release 202020 08/2022
    Tacrolimus https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210115.pdf Draft Oral For Suspension 210115 08/2022
    Upadacitinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211675.pdf Draft Oral Tablet, Extended Release 211675 08/2022
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