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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (Dec. 2013).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: 1896

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 2021

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Amlodipine Besylate; Celecoxib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210045.pdf Draft Oral Tablet 210045 05/2021
Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifenatate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209482.pdf Draft Inhalation Powder 209482 05/2021
Lumateperone Tosylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209500.pdf Draft Oral Capsule 209500 05/2021
Meloxicam https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210583.pdf Draft Intravenous Solution 210583 05/2021
Metoclopramide Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209388.pdf Draft Nasal Spray, Metered 209388 05/2021
Midazolam https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211321.pdf Draft Nasal Spray 211321 05/2021
Pexidartinib Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211810.pdf Draft Oral Capsule 211810 05/2021
Pitolisant Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211150.pdf Draft Oral Tablet 211150 05/2021
Quinidine Gluconate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_016647.pdf Draft Oral Tablet, Extended Release 016647 05/2021
Trifarotene https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211527.pdf Draft Topical Cream 211527 05/2021
Ubrogepant https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211765.pdf Draft Oral Tablet 211765 05/2021
Voxelotor https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213137.pdf Draft Oral Tablet 213137 05/2021
Zanubrutinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213217.pdf Draft Oral Capsule 213217 05/2021

Newly Revised Guidances since May 2021

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_050794.pdf Draft Intravenous, Subcutaneous Powder 050794 05/2021
Dasatinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021986.pdf Draft Oral Tablet 021986 05/2021
Fluticasone Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205434.pdf Draft Nasal Spray, Metered 205434 05/2021
Ledipasvir; Sofosbuvir https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205834.pdf Draft Oral Tablet 205834 05/2021
Nitrofurantoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_009175.pdf Draft Oral Suspension 009175 05/2021
Pentosan Polysulfate Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020193.pdf Draft Oral Capsule 020193 05/2021
Sofosbuvir https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_204671.pdf Draft Oral Tablet 204671 05/2021
Tofacitinib Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208246.pdf Draft Oral Tablet, Extended Release 208246 05/2021

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English