Guidances (Drugs) > Product-Specific Recommendations for Generic Drug Development
U.S. Food and Drug Administration
Home Drugs Guidance, Compliance & Regulatory Information Guidances (Drugs)
Product-Specific Recommendations for Generic Drug Development
SHARE TWEET LINKEDIN PIN IT EMAIL PRINT
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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance:
Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (Dec. 2013)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 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.
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075207.htm[6/16/2016 1:02:09 PM] Guidances (Drugs) > Product-Specific Recommendations for Generic Drug Development
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 to http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm064964.htm
Bioequivalence Recommendations for Specific Products Arranged by Active Ingredient [Total count 1454] 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 Type Route of Dosage Form RLD Date (link to Specific Administration Application Recommended Guidance) Number (link to Orange Book)
Amcinonide (PDF Draft Topical Lotion 76329 6/2016 -38KB)
Cariprazine HCl Draft Oral Capsule 204370 6/2016 (PDF - 40KB)
Draft Oral Tablet 206192 6/2016 Cobimetinib fumarate (PDF -58KB)
Empagliflozin and Draft Oral Tablet 206111 6/2016 http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075207.htm[6/16/2016 1:02:09 PM] Guidances (Drugs) > Product-Specific Recommendations for Generic Drug Development
Metformin HCl (PDF - 41KB)
Erythromycin Draft Oral Granule 050207 6/2016 ethylsuccinate (PDF - 39KB)
Everolimus (PDF Draft Oral Tablet 21560 6/2016 - 178KB)
Flibanserin (PDF Draft Oral Tablet 22526 6/2016 - 41KB)
Fluocinonide Draft Topical Gel 074935 6/2016 (PDF -38KB)
Fluocinonide Draft Topical Ointment 075008 6/2016 (PDF - 38KB)
Hydrocortisone Draft Topical Solution 81271 6/2016 (PDF - 35KB)
Lesinurad (PDF Draft Oral Tablet 207988 6/2016 -38KB)
Meloxicam (PDF - Draft Oral Capsule 07233 6/2016 40KB)
Draft Oral Tablet 91577 6/2016 Methylergonovine maleate (PDF -39KB)
Draft Oral Tablet 207931 6/2016 Ombitasvir; Paritaprevir; Ritonavir (PDF - 40KB)
Prednicarbate Draft Topical Ointment 19568 6/2016 (PDF - 38KB)
Propofol (PDF - Draft Injectable Injection 19627 6/2016 63KB)
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075207.htm[6/16/2016 1:02:09 PM] Guidances (Drugs) > Product-Specific Recommendations for Generic Drug Development
Draft Oral Tablet, 073585 6/2016 Extended Pseudoephedrine Release HCl (PDF - 40KB
Selexipag (PDF - Draft Oral Tablet 207947 6/2016 42KB)
Tacrolimus (PDF Draft Oral Tablet, 206406 6/2016 Extended - 49KB) Release
Newly Revised Bioequivalence Recommendations since June 1, 2016
Active Ingredient Type Route of Dosage Form RLD Date (link to Specific Guidance) Administration Application Recommended Number (link to Orange Book)
Acetaminophen; Draft Oral Tablet 89699 6/2016 Hydrocodone Bitartrate (PDF - 17 KB) Revised 81223 40100 40148 40099 40094
Albuterol Sulfate (PDF - 15 Draft Oral Tablet 72894 6/2016 KB) Revised
Azelastine HCl and Draft Nasal Spray, metered 202236 6/2016 fluticasone propionate (PDF - 78KB) Revised
Benzoyl Peroxide; Draft Topical Gel 50819 6/2016 Clindamycin Phosphate (PDF - 257KB) Revised
Dexamethasone; Draft Ophthalmic Ointment 50616 6/2016 Tobramycin (PDF - 64KB) Revised
Dexamethasone; Draft Ophthalmic Suspension 50818 6/2016 Tobramycin (PDF- 49KB)Revised
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075207.htm[6/16/2016 1:02:09 PM] Guidances (Drugs) > Product-Specific Recommendations for Generic Drug Development
Dexamethasone;Tobramycin Draft Ophthalmic Suspension 50592 6/2016 (PDF - 35 KB) Revised
Lansoprazole (PDF - 16KB) Draft Oral Tablet, Delayed- 21428 6/2016 Revised Release, Orally Disintegrating
Loteprednol Etabonate; Draft Ophthalmic Suspension 50804 6/2016 Tobramycin (PDF - 70KB)Revised
Loteprednol Etabonate (PDF Draft Ophthalmic Drops, 20583 6/2016 - 58KB)Revised suspension
Mesalamine (PDF - Draft Oral Capsule, Delayed 204412 6/2016 44KB) Revised Release
Mesalamine (PDF - Draft Oral Tablet, Delayed 21830 6/2016 67KB) Revised Release
Mesalamine (PDF - Draft Oral Tablet, Delayed 22000 6/2016 66KB) Revised Release
Methylphenidate (PDF - Draft Transdermal Film, Extended 21514 6/2016 266KB) Revised Release
Morphine Sulfate (PDF - Draft Oral Capsule, 20616 6/2016 23KB) Extended Release Revised
Paroxetine (PDF - Draft Oral Tablet, Extended 20936 6/2016 18KB) Revised Release
Pomalidomide (PDF - Draft Oral Capsule 204026 6/2016 24KB) Revised
Prednisolone Acetate (PDF - Draft Ophthalmic Suspension/Drops 17011 6/2016 69KB) Revised
Rimexolone (PDF - Draft Ophthalmic Drops, 020474 6/2016 21KB) Revised Suspension
Resources
Drug-Related Guidances
Bioequivalence Recommendations for Specific Products (PDF - 80KB) (updated 6/2010)
Dissolution Methods Database
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075207.htm[6/16/2016 1:02:09 PM] Guidances (Drugs) > Product-Specific Recommendations for Generic Drug Development
Withdrawn CDER Bioequivalence Recommendations (PDF - 50KB) (updated 3/29/2016)
Page Last Updated: 06/16/2016 Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Accessibility Careers FDA Basics FOIA No FEAR Act Site Map Transparency Website Policies
U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Contact FDA
FDA Archive Emergency Preparedness Federal, State & Local Officials Combination Products International Programs Consumers
Advisory Committees News & Events Health Professionals
Regulatory Information Training & Continuing Education Science & Research
Safety Inspections & Compliance Industry
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075207.htm[6/16/2016 1:02:09 PM]