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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: 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 1435]
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 April 1, 2016 (38 New; 6 Revisions) updated 4/14/2016

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

 Albendazole (PDF - 40KB)

 DraftOral Tablet, Chewable2078444/2016

 Amlodipine besylate; Perindopril arginine (PDF - 40KB) 

 Draft Oral

 Tablet

2050034/2016

 Betamethasone dipropionate  (PDF - 39KB)

 DraftTopicalCream, augmented195554/2016

 Chlorpheniramine polistirex; codeine polistirex (PDF - 41KB)

DraftOralSuspension, Extended Release2077684/2016

 Clobetasol propionate (PDF - 38KB)

DraftTopicalCream742204/2016

 Clobetasol propionate (PDF - 38KB)

DraftTopicalLotion215354/2016
  

Cobicistat; darunavir ethanolate  (PDF -39KB)

DraftOralTablet2053954/2016

 Daclatasvir dihydrochloride (PDF - 39KB)

DraftOralTablet2068434/2016

 Deferasirox  (PDF - 39KB)

Draft OralTablet2069104/2016

 Doxycycline hyclate  (PDF - 38KB)

DraftOralTablet0650954/2016

 Eluxadoline  (PDF - 41KB)

DraftOralTablet2069404/2016

 Empagliflozin; Linagliptin (PDF - 57KB)

DraftOralTablet2060734/2016

 Erythromycin ethylsuccinate (PDF - 39KB)

DraftOralTablet

061904


061905

4/2016

 Ferric carboxymaltose (PDF - 59KB)

DraftIntravenousInjectable2035654/2016

 Fluticasone Furoate; Vilanterol Trifenatate (PDF - 108KB)

DraftInhalationPowder2042754/2016

 Fluticasone Furoate (PDF - 101KB)

DraftInhalationPowder2056254/2016

 Gefitinib (PDF - 39KB)

DraftOralTablet2069954/2016

 Glatiramer acetate (PDF - 51KB)

DraftSubcutaneousInjection206224/2016

 Halobetasol propionate (PDF - 39KB)

DraftTopicalCream199674/2016

 Halobetasol propionate (PDF - 39KB)

DraftTopicalOintment199684/2016

 Indacaterol maleate (PDF - 98KB)

Draft InhalationPowder223834/2016

 Isavuconazonium sulfate (PDF - 39KB)

DraftOralCapsule2075004/2016

 Ivabradine hydrochloride (PDF - 41KB) 

 

DraftOralTablet2061434/2016

 Ivacaftor; Lumacaftor (PDF - 41KB)

DraftOralTablet2060384/2016

 Ivacaftor  (PDF - 44KB)

DraftOralGranule2079254/2016

 Lenvatinib mesylate (PDF - 41KB)

DraftOralCapsule2069474/2016

 Mometasone furoate (PDF - 101KB)

DraftInhalationAerosol, Metered2056414/2016

 Mometasone furoate (PDF - 38KB)

DraftTopicalCream0196254/2016

 Mometasone furoate (PDF - 41KB)

DraftTopicalLotion197964/2016

 Oxaprozin  (PDF - 39KB)

DraftOralTablet

 18841 

4/2016

 Oxybutynin chloride (PDF - 37KB)

DraftTransdermalGel222044/2016

 Palbociclib  (PDF - 34KB)

DraftOralCapsule2071034/2016

 Sacubitril; Valsartan (PDF - 39KB)

DraftOralTablet2076204/2016

 Sonidegib Phosphate (PDF - 56KB)

DraftOralCapsule2052664/2016

 Tazarotene  (PDF - 151KB)

DraftTopicalFoam2024284/2016

 Triamcinolone acetonide  (PDF - 32KB)

DraftTopicalCream0856924/2016

 Triamcinolone acetonide  (PDF - 32KB)

DraftTopicalOintment0873574/2016

 Triamcinolone acetonide  (PDF - 32KB)

DraftTopicalOintment0895954/2016

 

Newly Revised Bioequivalence Recommendations since April 1, 2016

Active Ingredient
(link to Specific Guidance)
TypeRoute of AdministrationDosage FormRLD Application Number
(link to Orange Book)
Date Recommended
 
Ciprofloxacin; Dexamethasone (PDF - 149KB RevisedDraft OticSuspension/Drops215374/2016
Cyclosporine (PDF - 40KB) RevisedDraftOralCapsule0506256/2016
Cyclosporine (PDF - 40KB)RevisedDraftOralCapsule (modified)0507154/2016
Testosterone (PDF - 172KB) RevisedDraftTransdermalFilm, Extended Release0204894/2016

 Ticagrelor (PDF - 41KB) Revised

DraftOralTablet0224334/2016
Valganciclovir HCl (PDF - 21KB) RevisedDraftOralTablet213044/2016

 

 

Page Last Updated: 04/14/2016
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