FDA has published 48 finalized product-specific guidances describing the Agency’s current thinking and expectations on how to develop generic drug products that are therapeutically equivalent to specific reference-listed drugs.
FDA always seeks feedback and considers all comments to the docket before it begins work on the final versions of product-specific guidances.
For more information and to view the guidances, visit http://www.fda.gov/drugs/
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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (Dec. 2013).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.
These guidances are published in an incremental manner and listed below in alphabetical order according to RLD’s name. The most recently published guidances (new and revised) are listed below.
Some of the CDER OGD Product Specific Guidances include discussion regarding data formats. Please note that under section 745A(a) of the Food, Drug & 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.
The Agency is seeking feedback and considers comments to the docket on these guidances. The comments should be submitted to the Division of Dockets Management (DDM) under Docket FDA-2007-D-0369-0015. For electronic comments, refer to the website http://www.regulations.gov OR mail your written comments to DDM (HFA-305), FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Please contact the Regulations.gov Help Desk at 1-877-378-5457 (toll free) for assistance regarding submissions.
For additional information on development of generic drug products refer to Biopharmaceutics
Product-Specific Guidances Arranged by Active Ingredient
Newly Added Guidances since July 1, 2017 (21 New; 13 Revisions; 48 Finalized) updated 8/4/2017
| Active Ingredient (link to Specific Guidance) | Type | Route of Administration | Dosage Form | RLD Application Number (link to Orange Book) | Date Recommended |
|---|---|---|---|---|---|
| Draft | Oral | Tablets, Delayed release | 205103 | 7/2017 | |
| Draft | Oral | Capsule, Extended Release | 200671 | 7/2017 | |
| Draft | Oral | Tablet | 205422 | 7/2017 | |
| Draft | Oral | Tablet | 205836 | 7/2017 | |
| Draft | Oral | Powder for Suspension | 050749 | 7/2017 | |
| Draft | Topical | Cream | 017765 | 7/2017 | |
| Draft | Nasal | Spray | 021642 | 7/2017 | |
| Draft | Oral | Tablets, Extended Release | 208624 | 7/2017 | |
| Draft | Oral | Tablet | 040361 | 7/2017 | |
| Draft | Topical | Solution | 204623 | 7/2017 | |
| Draft | Oral | Tablet | 089804 | 7/2017 | |
| Draft | Topical | Cream | 062307 | 7/2017 | |
| Draft | Inhalation | Powder | 7/2017 | ||
| Draft | Oral | Tablet | 207999 | 7/2017 | |
| Draft | Topical | Cream | 017381 | 7/2017 | |
| Draft | Oral | Tablet | 208464 | 7/2017 | |
| Draft | Oral | Tablet | 19569 | 7/2017 | |
| Draft | Oral | Tablet | 207981 | 7/2017 | |
| Draft | Topical | Lotion | 011602 | 7/2017 | |
| Draft | Topical | Ointment | 087356 | 7/2017 | |
| Draft | Oral | Granules | 7/2017 | ||
Newly Revised Guidances since July 1, 2017
| Active Ingredient (link to Specific Guidance) | Type | Route of Administration | Dosage Form | RLD Application Number (link to Orange Book) | Date Recommended |
|---|---|---|---|---|---|
| Brimonidine Tartrate (PDF - 87KB) Revised | Draft | Ophthalmic | Solution/Drops | 7/2017 | |
| Dabigatran Etexilate Mesylate (PDF - 42KB) Revised | Draft | Oral | Capsule | 22512 | 7/2017 |
Dorzolamide HCl (PDF - 84KB) Revised | Draft | Ophthalmic | Solution/drops | 20408 | 7/2017 |
Gefitinib (PDF - 39KB) Revised | Draft | Oral | Tablet | 206995 | 7/2017 |
| Latanoprost (PDF - 14KB) Revised | Draft | Ophthalmic | Solution | 20597 | 7/2017 |
| Methoxsalen (PDF - 24KB) Revised | Draft | Oral | Capsule | 19600 | 7/2017 |
| Metoprolol tartrate (PDF - 22KB) Revised | Draft | Oral | Tablet | 076704 | 7/2017 |
| Minocycline HCl (PDF - 15KB) Revised | Draft | Oral | Capsule | 7/2017 | |
| Minocycline HCl (PDF - 29KB) Revised | Draft | Oral | Tablet | 50451 | 7/2017 |
| Minoxidil (PDF - 15KB)Revised | Draft | Oral | Tablet | 7134471345 | 7/2017 |
| Pimozide (PDF - 18KB) Revised | Draft | Oral | Tablet | 17473 | 7/2017 |
| Propafenone HCl (PDF - 35KB) Revised | Draft | Oral | Tablet | 19151 | 7/2017 |
| Tetrabenazine (PDF - 46KB) Revised | Draft | Oral | Tablet | 21894 | 7/2017 |
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