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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (Dec. 2013).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 1456]
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 (20 New; 21Revisions) updated 8/29/2016

Active Ingredient
(link to Specific Guidance)
TypeRoute of AdministrationDosage FormRLD Application Number
(link to Orange Book)
Date Recommended
 

 Amcinonide (PDF -38KB) 

 DraftTopical Lotion763296/2016

 Cariprazine HCl (PDF - 40KB)

 Draft Oral

Capsule

2043706/2016

 Cobimetinib fumarate (PDF -58KB)

 DraftOralTablet2061926/2016

 Empagliflozin and Metformin HCl (PDF - 41KB) 

DraftOralTablet2061116/2016

 Erythromycin ethylsuccinate (PDF - 39KB)

DraftOralGranule0502076/2016

 Everolimus (PDF - 178KB)

DraftOralTablet215606/2016

Fidaxomicin (PDF -26KB) the word new in a red box

DraftOralTablet2016998/2016
 Flibanserin (PDF - 41KB)DraftOralTablet225266/2016

 Fluocinonide (PDF -38KB)

DraftTopicalGel0749356/2016

Fluocinonide (PDF - 38KB)

Draft TopicalOintment0750086/2016

Hydrocortisone (PDF - 35KB)

DraftTopicalSolution812716/2016

 Lesinurad (PDF -38KB)

DraftOralTablet2079886/2016

 Meloxicam (PDF - 40KB)

DraftOralCapsule2072336/2016

Methylergonovine maleate (PDF -39KB)

DraftOralTablet

91577

6/2016

 Ombitasvir; Paritaprevir; Ritonavir (PDF - 40KB)

DraftOralTablet2079316/2016

 Prednicarbate (PDF - 38KB)

DraftTopicalOintment195686/2016

 Propofol (PDF - 63KB)

DraftInjectableInjection196276/2016

 Pseudoephedrine HCl (PDF - 40KB

DraftOralTablet, Extended Release0735856/2016

 Selexipag (PDF - 42KB)

DraftOralTablet2079476/2016

 Tacrolimus (PDF - 49KB)

DraftOralTablet, Extended Release2064066/2016

 

Newly Revised Bioequivalence Recommendations since June 1, 2016

Active Ingredient
(link to Specific Guidance)
TypeRoute of AdministrationDosage FormRLD Application Number
(link to Orange Book)
Date Recommended
Acetaminophen; Hydrocodone Bitartrate (PDF - 17 KB) RevisedDraftOralTablet

89699

81223

40100

40148

40099

40094

6/2016
Albuterol Sulfate (PDF - 15 KB) RevisedDraftOralTablet728946/2016

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

DraftNasalSpray, metered2022366/2016
Benzoyl Peroxide; Clindamycin Phosphate (PDF - 257KB)   RevisedDraftTopicalGel508196/2016
Dexamethasone; Tobramycin (PDF - 64KB) RevisedDraft OphthalmicOintment50616 6/2016
Dexamethasone; Tobramycin (PDF-49KB)RevisedDraftOphthalmicSuspension508186/2016
Dexamethasone;Tobramycin (PDF - 35 KB) RevisedDraftOphthalmicSuspension505926/2016
Lansoprazole (PDF - 16KB)
Revised
DraftOralTablet, Delayed-Release, Orally Disintegrating214286/2016
Loteprednol Etabonate; Tobramycin (PDF - 70KB)Revised DraftOphthalmicSuspension508046/2016
Loteprednol Etabonate (PDF - 58KB)RevisedDraftOphthalmicDrops, suspension

20583

6/2016
Mesalamine (PDF - 44KB) RevisedDraftOralCapsule, Delayed Release2044126/2016
Mesalamine (PDF - 67KB) RevisedDraft OralTablet, Delayed Release218306/2016
Mesalamine (PDF - 66KB) RevisedDraft OralTablet, Delayed Release220006/2016

Methylphenidate (PDF - 266KB) Revised

DraftTransdermalFilm, Extended Release215146/2016
Morphine Sulfate (PDF - 23KB)
Revised
DraftOralCapsule, Extended Release206166/2016
Paliperidone Palmitate (PDF - 35KB) RevisedDraftInjection, IntramuscularSuspension, Extended Release222647/2016
Paroxetine (PDF - 18KB) RevisedDraftOralTablet, Extended Release209366/2016

Pomalidomide (PDF - 24KB) Revised

DraftOralCapsule2040266/2016
Prednisolone Acetate (PDF - 69KB) RevisedDraftOphthalmicSuspension/Drops170116/2016
Rimexolone (PDF - 21KB) RevisedDraftOphthalmicDrops, Suspension0204746/2016
Risperidone (PDF - 47KB) RevisedDraftIntramuscularInjection213468/2016

 

 

Page Last Updated: 08/29/2016
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