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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (Dec. 2013).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 1523]
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 Oct. 1, 2016 (34 New; 33 Revisions) updated 10/4/2016

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

 Acetaminophen; Oxycodone hydrochloride (PDF - 74KB)

 Draft Oral

Tablet, Extended Release

20403110/2016

 Alectinib hydrochloride (PDF - 63KB)

 Draft Oral

Capsule

20843410/2016

 Betamethasone dipropionate (PDF - 33KB)

 DraftTopicalCream01913710/2016

 Betamethasone valerate (PDF - 31KB)

DraftTopicalOintment1886510/2016

 Captopril (PDF - 38KB)

DraftOralTablet07443410/2016

 Carbidopa; Levodopa (PDF - 34KB)

DraftOralTablet1755510/2016

 Cholic Acid (PDF - 39KB)

DraftOralCapsule20575010/2016
 

Clobetasol propionate (PDF - 38KB)

DraftTopicalCream (emollient)7543010/2016

 Clobetasol propionate (PDF - 38KB)

Draft TopicalGel7536810/2016

 Cobicistat; Elvitegravir; Emtricitabine; Tenofovir alafenamide fumarate (PDF - 35KB)

DraftOralTablet20756110/2016

 Crotamiton (PDF - 37KB)

DraftTopicalCream00692710/2016

 Crotamiton (PDF - 38KB)

DraftTopicalLotion00911210/2016

 Desonide (PDF - 35KB)

DraftTopicalOintment

017426

10/2016

 Dexlansoprazole (PDF - 51B)

DraftOralTablet, Delayed release orally disintegrating20805610/2016

 Elbasvir; Grazoprevir (PDF -40KB)

DraftOralTablet20826110/2016

 Eltrombopag Olamine (PDF - 46KB)

DraftOralSuspension20702710/2016

 Esomeprazole Magnesium (PDF - 39KB)

DraftOralTablet, Delayed Release20792010/2016

 Fluticasone propionate (PDF - 30KB)

DraftTopicalOintment1995710/2016

 Halobetasol Propionate (PDF - 36KB)

DraftTopicalLotion20818310/2016

 Hydrocodone bitartrate (PDF - 55KB)

DraftOralCapsule, Extended Release20288010/2016

 Hydrocodone bitartrate (PDF - 78KB)

DraftOralTablet, Extended Release20662710/2016

 Hydrocortisone valerate (PDF - 38KB)

DraftTopicalOintment7504310/2016

 Ibuprofen (PDF - 22KB)

DraftOralSuspension07497810/2016

 Iron dextran (PDF  - 53KB)

DraftInjectableInjection01744110/2016

 Methylphenidate HCl (PDF - 39KB)

DraftOralTablet, Chewable20796010/2016

 Morphine Sulfate (PDF - 47KB

DraftOralSolution02219510/2016

 Olopatadine hydrochloride (PDF - 41KB)

DraftNasalSpray, Metered02186110/2016

 Oxymorphone HCL (PDF - 58KB)

DraftOralTablet, Extended Release20165510/2016

 Prochlorperazine (PDF - 40KB)

DraftRectalSuppository04005810/2016

 Pyrazinamide (PDF - 22KB)

DraftOralTablet08015710/2016

 Rolapitant  (PDF - 23KB)

DraftOralTablet20650010/2016

 Triamcinolone acetonide (PDF - 170KB)

DraftNasalSpray, metered02046810/2016

 Triamcinolone acetonide (PDF  - 32KB)

DraftTopicalOintment08738510/2016

 Umeclidinium bromide (PDF - 105KB)

DraftInhalationPowder20538210/2016

 

Newly Revised Bioequivalence Recommendations since Oct. 1, 2016

Active Ingredient
(link to Specific Guidance)
TypeRoute of AdministrationDosage FormRLD Application Number
(link to Orange Book)
Date Recommended
Bacitracin (PDF - 39KB) Revised Draft OphthalmicOintment6121210/2016

Buprenorphine (PDF - 161KB) Revised

DraftTransdermalFilm, Extended Release

21306

10/2016
Clonidine (PDF - 133KB)  RevisedDraftTransdermalFilm, Extended Relese1889110/2016

 Cyclobenzaprine HCl (PDF - 26KB) Revised

DraftOralCapsule, Extended Release2177711/2016

Cyclosporine  (PDF - 48KB) Revised

DraftOphthalmicEmulsion

50790

10/2016
Dexlansoprazole (PDF - 64KB) RevisedDraftOralCapsule, Delayed Release22287  10/2016
Diclofenac Epolamine (PDF - 202KB)  Revised DraftTopicalPatch2123410/2016
 Erythromycin (PDF - 40KB)  Revised Draft OphthalmicOintment6244710/2016

Estradiol (PDF - 155KB) Revised

DraftTransdermalFilm, Extended Release20375210/2016
Estradiol (PDF - 146KB) RevisedDraftTransdermalFilm, Extended Release1908110/2016
Estradiol (PDF - 148KB) RevisedDraftTransdermalFilm, Extended Release

20375

21674

10/2016
Estradiol (PDF - 137KB) RevisedDraftTransdermalFilm, Extended Release2053810/2016
Ethinyl Estradiol; Norelgestromin (PDF - 142KB) RevisedDraftTransdermalFilm, Extended Release20091010/2016

Fentanyl (PDF - 105KB)  Revised

 

DraftTransdermalFilm, Extended Release1981310/2016
Granisetron (PDF - 153KB) RevisedDraftTransdermalFilm, Extended Release2219810/2016
Icosapent Ethyl (PDF - 72KB) RevisedDraftOralCapsule20205710/2016
Lansoprazole (PDF - 54KB) Revised
DraftOralTablet, Delayed-Release, Orally Disintegrating2142810/2016
Lidocaine (PDF - 449KB)  RevisedDraftTopicalPatch02061210/2016

Menthol; Methyl Salicylate (PDF -189KB) Revised 

DraftTopicalPatch2202910/2016
Mesalamine (PDF - 36KB) Revised Draft OralTablet, Delayed Release1965110/2016

Methylphenidate (PDF - 166KB)  Revised

DraftTransdermalFilm, Extended Release2151410/2016
Morphine Sulfate (PDF - 23KB)  RevisedDraftOralCapsule, Extended Release2061610/2016

Nicotine (PDF - 138KB)  Revised

DraftTransdermalFilm, Extended Release20076

 

20165

10/2016
Nitroglycerin (PDF - 154KB) Revised DraftTransdermalFilm, Extended Release2014510/2016
Nitroglycerin (PDF - 158KB)  RevisedDraftTransdermalFilm, Extended Release7455910/2016
Omega-3-Acid Ethyl Esters (PDF - 82KB)  RevisedDraft OralCapsule2165410/2016
Oxycodone HCl (PDF - 45B)  RevisedDraftOralTablet, Extended Release2227210/2016

 Oxybutynin (PDF - 179KB)  Revised

DraftTransdermalFilm, Extended Release20221110/2016
Pantoprazole Sodium (PDF - 56KB)  RevisedDraftOralGranules, Delayed Release Suspension2202010/2016
Rivastigmine (PDF - 156KB) RevisedDraftTransdermalFilm, Extended Release2208310/2016
 Rotigotine (PDF - 143KB)  Revised Draft TransdermalFilm, Extended Release2182910/2016
Scopolamine (PDF - 140KB) Revised
Draft, RevisionTransdermalFilm, Extended Release1787410/2016
Selegiline (PDF - 141KB) RevisedDraft RevisionTransdermalFilm, Extended Release2133610/2016
Testosterone (PDF - 145KB)  RevisedDraftTransdermalFilm, Extended Release02048910/2016

 

 

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