FDA has published 33 product-specific recommendations (18 new and 15 revised) 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 BE guidances.
For more information and to view the recommendations, visit http://www.fda.gov/drugs/
Product-Specific Recommendations 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 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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance:
To further facilitate generic drug product availability and to assist generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support ANDA approval, FDA publishes product-specific recommendations describing the Agency’s current thinking and expectations on how to develop generic drug products therapeutically equivalent to specific reference-listed drugs.
These recommendations are published in an incremental manner and listed below in alphabetical order according to RLD’s name. The most recently published recommendations (new and revised) are listed below.
The Agency is seeking feedback and considers comments to the docket on these recommendations. 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 tohttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm064964.htm
Bioequivalence Recommendations for Specific Products Arranged by Active Ingredient
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
Newly Added Recommendations since June 1, 2016 (19 New; 19 Revisions) updated 6/16/2016
| Active Ingredient (link to Specific Guidance) | Type | Route of Administration | Dosage Form | RLD Application Number (link to Orange Book) | Date Recommended |
|---|---|---|---|---|---|
| Draft | Topical | Lotion | 76329 | 6/2016 | |
| Draft | Oral |
Capsule
| 204370 | 6/2016 | |
| Draft | Oral | Tablet | 206192 | 6/2016 | |
| Draft | Oral | Tablet | 206111 | 6/2016 | |
| Draft | Oral | Granule | 050207 | 6/2016 | |
| Draft | Oral | Tablet | 21560 | 6/2016 | |
| Flibanserin (PDF - 41KB) | Draft | Oral | Tablet | 22526 | 6/2016 |
| Draft | Topical | Gel | 074935 | 6/2016 | |
| Draft | Topical | Ointment | 075008 | 6/2016 | |
| Draft | Topical | Solution | 81271 | 6/2016 | |
| Draft | Oral | Tablet | 207988 | 6/2016 | |
| Draft | Oral | Capsule | 07233 | 6/2016 | |
| Draft | Oral | Tablet | 6/2016 | ||
| Draft | Oral | Tablet | 207931 | 6/2016 | |
| Draft | Topical | Ointment | 19568 | 6/2016 | |
| Draft | Injectable | Injection | 19627 | 6/2016 | |
| Draft | Oral | Tablet, Extended Release | 073585 | 6/2016 | |
| Draft | Oral | Tablet | 207947 | 6/2016 | |
| Draft | Oral | Tablet, Extended Release | 206406 | 6/2016 | |
Newly Revised Bioequivalence Recommendations since June 1, 2016
| Active Ingredient (link to Specific Guidance) | Type | Route of Administration | Dosage Form | RLD Application Number (link to Orange Book) | Date Recommended |
|---|---|---|---|---|---|
| Acetaminophen; Hydrocodone Bitartrate (PDF - 17 KB) Revised | Draft | Oral | Tablet | 6/2016 | |
| Albuterol Sulfate (PDF - 15 KB) Revised | Draft | Oral | Tablet | 72894 | 6/2016 |
| Draft | Nasal | Spray, metered | 202236 | 6/2016 | |
| Benzoyl Peroxide; Clindamycin Phosphate (PDF - 257KB) Revised | Draft | Topical | Gel | 50819 | 6/2016 |
| Dexamethasone; Tobramycin (PDF - 64KB) Revised | Draft | Ophthalmic | Ointment | 50616 | 6/2016 |
| Dexamethasone; Tobramycin (PDF-49KB)Revised | Draft | Ophthalmic | Suspension | 50818 | 6/2016 |
| Dexamethasone;Tobramycin (PDF - 35 KB) Revised | Draft | Ophthalmic | Suspension | 50592 | 6/2016 |
| Lansoprazole (PDF - 16KB)Revised | Draft | Oral | Tablet, Delayed-Release, Orally Disintegrating | 21428 | 6/2016 |
| Loteprednol Etabonate; Tobramycin (PDF - 70KB)Revised | Draft | Ophthalmic | Suspension | 50804 | 6/2016 |
| Loteprednol Etabonate (PDF - 58KB)Revised | Draft | Ophthalmic | Drops, suspension | 6/2016 | |
| Mesalamine (PDF - 44KB) Revised | Draft | Oral | Capsule, Delayed Release | 204412 | 6/2016 |
| Mesalamine (PDF - 67KB) Revised | Draft | Oral | Tablet, Delayed Release | 21830 | 6/2016 |
| Mesalamine (PDF - 66KB) Revised | Draft | Oral | Tablet, Delayed Release | 22000 | 6/2016 |
Methylphenidate (PDF - 266KB) Revised
| Draft | Transdermal | Film, Extended Release | 21514 | 6/2016 |
| Morphine Sulfate (PDF - 23KB) Revised | Draft | Oral | Capsule, Extended Release | 20616 | 6/2016 |
| Paroxetine (PDF - 18KB) Revised | Draft | Oral | Tablet, Extended Release | 20936 | 6/2016 |
Pomalidomide (PDF - 24KB) Revised
| Draft | Oral | Capsule | 204026 | 6/2016 |
| Prednisolone Acetate (PDF - 69KB) Revised | Draft | Ophthalmic | Suspension/Drops | 17011 | 6/2016 |
| Rimexolone (PDF - 21KB) Revised | Draft | Ophthalmic | Drops, Suspension | 020474 | 6/2016 |
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