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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: 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 to http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm064964.htm  
 

 

Bioequivalence Recommendations for Specific Products Arranged by Active Ingredient [Total count 1455]
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; 20 Revisions) updated 6/30/2016

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

 Amcinonide (PDF -38KB) 

 Draft Topical  Lotion 76329 6/2016

 Cariprazine HCl (PDF - 40KB)

 Draft  Oral

Capsule

204370 6/2016

 Cobimetinib fumarate (PDF -58KB)

 Draft Oral Tablet 206192 6/2016

 Empagliflozin and Metformin HCl (PDF - 41KB) 

Draft Oral Tablet 206111 6/2016

 Erythromycin ethylsuccinate (PDF - 39KB)

Draft Oral Granule 050207 6/2016

 Everolimus (PDF - 178KB)

Draft Oral Tablet 21560 6/2016
 Flibanserin (PDF - 41KB) Draft Oral Tablet 22526 6/2016

 Fluocinonide (PDF -38KB)

Draft Topical Gel 074935 6/2016

Fluocinonide (PDF - 38KB)

Draft  Topical Ointment 075008 6/2016

Hydrocortisone (PDF - 35KB)

Draft Topical Solution 81271 6/2016

 Lesinurad (PDF -38KB)

Draft Oral Tablet 207988 6/2016

 Meloxicam (PDF - 40KB)

Draft Oral Capsule 207233 6/2016

Methylergonovine maleate (PDF -39KB)

Draft Oral Tablet

91577

6/2016

 Ombitasvir; Paritaprevir; Ritonavir (PDF - 40KB)

Draft Oral Tablet 207931 6/2016

 Prednicarbate (PDF - 38KB)

Draft Topical Ointment 19568 6/2016

 Propofol (PDF - 63KB)

Draft Injectable Injection 19627 6/2016

 Pseudoephedrine HCl (PDF - 40KB

Draft Oral Tablet, Extended Release 073585 6/2016

 Selexipag (PDF - 42KB)

Draft Oral Tablet 207947 6/2016

 Tacrolimus (PDF - 49KB)

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

89699

81223

40100

40148

40099

40094

6/2016
Albuterol Sulfate (PDF - 15 KB) Revised Draft Oral Tablet 72894 6/2016

 Azelastine HCl and fluticasone propionate (PDF - 78KB) Revised

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

20583

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
Paliperidone Palmitate (PDF - 35KB) Revised Draft Injection, Intramuscular Suspension, Extended Release 22264 7/2016
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

 

 

Page Last Updated: 07/19/2016
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