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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (Dec. 2013).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

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 Biopharmaceutics  

Bioequivalence Recommendations for Specific Products Arranged by Active Ingredient [Total count 1554]
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 Dec. 1, 2016 (31 New; 17 Revisions) updated 12/22/2016

Active Ingredient
(link to Specific Guidance)
Type Route of Administration Dosage Form RLD Application Number
(link to Orange Book)
Date Recommended
 

 Adapalene; Benzoyl peroxide (PDF - 159KB)

 Draft Topical

Gel

207917 12/2016

 Amphetamine (PDF - 71KB) 

 Draft  Oral

Suspension, Extended Release

208147 12/2016

 Betamethasone valerate (PDF - 35KB) 

 Draft Topical Cream 018861 12/2016

 Budesonide (PDF - 107KB)

Draft Inhalation Powder 21949 12/2016

 Cephalexin (PDF - 37KB)

Draft Oral Suspension 062703 12/2016

 Cetirizine hydrochloride (PDF - 40KB)

Draft Oral Tablet 019835 12/2016

 Clozapine (PDF - 70KB)

Draft Oral Suspension 203479 12/2016
 

Colchicine (PDF - 38KB)

Draft Oral Capsule 204820 12/2016

 Doxycycline hyclate (PDF - 38KB)

Draft  Oral Capsule 208253 12/2016

 Emtricitabine; Rilpivirine hydrochloride; Tenofovir alafenamide fumarate (PDF - 25KB)

Draft Oral Tablet 208351 12/2016

 

Emtricitabine; Tenofovir alafenamide fumarate (PDF - 39KB)

 

Draft Oral Tablet 208215 12/2016

 Epinephrine (PDF - 54KB)

Draft Intramuscular, subcutaneous Injection 19430 12/2016

 Esomeprazole magnesium (PDF - 69KB)

Draft Oral Capsule, Delayed Release 204655 12/2016

 Ethiodized oil (PDF - 43KB)

Draft

 intralymphatic,
intrauterine,
selective hepatic intra-arterial

Injectable

009190

12/2016

 Fenofibrate (PDF - 39KB)

Draft Oral Capsule 021695 12/2016

 Fluocinonide (PDF - 35KB)

Draft Topical Cream 21758 12/2016

 Fluoxetine HCl (PDF - 59KB)

Draft Oral Tablet 202133 12/2016

 Halcinonide (PDF - 35KB)

Draft Topical Cream 017556 12/2016

Ibuprofen; Pseudoephedrine HCl (PDF - 39KB) 

Draft Oral Capsule 21374 12/2016

 Lidocaine (PDF - 39KB)

Draft Topical Ointment 080198 12/2016

 Morphine sulfate (PDF - 43KB)

Draft Oral Tablet, Extended Release 206544 12/2016

 Nicotine polacrilex (PDF - 41KB)

Draft Oral Troche/lozenge 21330 12/2016

 Nitisinone (PDF - 59KB)

Draft Oral Suspension 206356 12/2016

Omega-3-acid Ethyl Esters Type A (PDF - 93KB)

Draft Oral Capsule 204977 12/2016

 Oxycodone (PDF - 54KB)  

Draft Oral Capsule, Extended Release 208090 12/2016

 Panobinostat lactate (PDF - 41KB)

Draft Oral Capsule 205353 12/2016

 Perampanel (PDF - 61KB)

Draft Oral Suspension 208277 12/2016

 Pimavanserin tartrate (PDF - 63KB)

Draft Oral Tablet 207318 12/2016

 Prazosin HCl (PDF - 39KB)

Draft Oral Capsule 17442 12/2016

 Simvastatin (PDF - 39KB)

Draft Oral Suspension 206679 12/2016

 Tofacitinib citrate (PDF - 39KB)

Draft Oral Tablet, Extended Release 208246 12/2016

 

Newly Revised Bioequivalence Recommendations since Dec. 1, 2016

Active Ingredient
(link to Specific Guidance)
Type Route of Administration Dosage Form RLD Application Number
(link to Orange Book)
Date Recommended
Acyclovir  (PDF - 85KB) Revised  Draft  Topical Cream, 5% 021478 12/2016

 

Albuterol Sulfate (PDF - 144KB) Revised

 Draft  Inhalation Aerosol, Metered

20503

20983

21457

 12/2016

Buprenorphine HCl; Naloxone HCl (PDF - 26KB) Revised

Draft  Sublingual Film 022410 12/2016
Buprenorphine HCl; Naloxone HCl (PDF - 23KB)  Revised  Draft Oral Tablet, Sublingual 204242 12/2016
  

Cobicistat; darunavir ethanolate  (PDF -39KB) Revised

Draft Oral Tablet 205395 12/2016
Divalproex Sodium (PDF-19KB) Revised Draft Oral Tablet, Delayed Release 18723 12/2016
Divalproex Sodium (PDF-19KB) Revised Draft Oral Capsule, Delayed Release Pellets 19680 12/2016
Divalproex Sodium (PDF-57KB) Revised Draft Oral Tablet, Extended Release 21168 12/2016

 Levomilnacipran HCl (PDF - 25KB) Revised

Draft Oral Capsule, Extended Release 204168 12/2016

 Medroxyprogesterone Acetate (PDF - 24KB Revised

Draft  Intramuscular Suspension 020246 12/2016
Nepafenac (PDF - 73KB) Revised Draft Ophthalmic Drops, Suspension 0.1% 21862 12/2016
Nepafenac (PDF - 78KB)  Revised Draft Ophthalmic Drops, Suspension 0.3% 203491 12/2016

Omega-3 Carboxylic Acids (PDF - 84KB)Revised

Draft Oral Capsule 205060 12/2016
Omega-3-Acid Ethyl Esters (PDF - 82KB)  Revised Draft  Oral Capsule 21654 12/2016

 Ruxolitinib phosphate (PDF - 39KB) Revised

Draft Oral Tablet 202192 12/2016

 Tedizolid phosphate (PDF - 23KB) Revised

Draft Oral Tablet 205435 12/2016
Venlafaxine HCl (PDF - 28KB) Revised Draft Oral Tablet 76690 12/2016

 

 

Page Last Updated: 12/22/2016
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