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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: 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 1321]
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 - June 2015 (44 New) 4 Revisions updated 7/1/2015

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

 

Abacavir sulfate; Dolutegravir sodium; Lamivudine  (PDF - 39KB)

 Draft OralTablet2055516/2015

 Afatinib dimaleate (PDF - 22KB)

 Draft Oral

 Tablet

2012926/2015

 Alendronate sodium (PDF - 40KB)

 Draft OralTablet, Effervescent2023446/2015

 Aspirin (PDF -KB)

DraftOralCapsule2036976/2015

 Azelastine HCl and fluticasone propionate (PDF - 78KB)

DraftNasalSpray, metered2022366/2015

 Budesonide; Formoterol fumarate dihydrate (PDF - 100KB)

DraftInhalationAerosol, metered0219296/2015
 

 Calcium carbonate; Famotidine; Magnesium hydroxide (PDF - 23KB)

DraftOralTablet, Chewable209586/2015

 Canagliflozin; Metformin HCl (PDF -24KB)

DraftOralTablet2043536/2015

 Cyclophosphamide (PDF - 43KB)

Draft OralCapsule2038566/2015

Cyproheptadine HCl (PDF - 37KB)

DraftOralTablet0870566/2015

Dabrafenib mesylate (PDF - 24KB)  

DraftOralCapsule2028066/2015

Dapagliflozin Propanediol (PDF - 23KB) 

DraftOralTablet2022936/2015

Dexbrompheniramine maleate; pseudoephedrine sulfate (PDF - 42KB)

DraftOralCapsule786486/2015

Dolutegravir sodium (PDF - 39KB)

Draft OralTablet2047906/2015

Donepezil HCl; Memantine HCl (PDF - 48KB)

DraftOralCapsule, Extended Release2064396/2015

Doxycycline hyclate (PDF - 42KB)

DraftOralTablet2059316/2015

 Droxidopa (PDF -39KB)

DraftOralCapsule2032023/2015

 Eliglustat tartrate (PDF - 39KB)

DraftOralCapsule2054946/2015

 Empagliflozin (PDF - 23KB) 

DraftOralTablet2046296/2015

 Emtricitabine; Tenofovir disoproxil fumarate (PDF - 23KB)

DraftOralTablet217526/2015

 Enzalutamide (PDF - 61KB)

Draft OralCapsule2034156/2015

 Fentanyl (PDF - 39KB)

DraftSublingualSpray2027886/2015

 Indomethacin (PDF - 38KB)

DraftOralCapsule2047686/2015

 Lanthanum carbonate (PDF - 31KB)

DraftOralPowder2047346/2015

 Levalbuterol tartrate  (PDF - 105KB)

DraftInhalationAerosol, metered217306/2015

 Levomilnacipran HCl (PDF - 25KB) 

DraftOralCapsule, Extended Release2041686/2015

 Macitentan (PDF - 91KB)

DraftOralTablet2044106/2015

 Methazolamide (PDF - 55KB)

DraftOralTablet0400626/2015

 Miglitol (PDF - 70KB)

DraftOralTablet0206826/2015

 Naloxegol oxalate (PDF -39KB)

DraftOralTablet2047606/2015

 Naproxen sodium (PDF - 22KB)

DraftOralCapsule219206/2015

 Nitroglycerin  (PDF - 39KB)

DraftTransdermalOintment0873556/2015

 Omeprazole; sodium bicarbonate (PDF - 59KB)

DraftOralSuspension, powder222836/2015

 Oxybutynin (PDF - 171KB)

DraftTransdermalFilm, Extended Release2022116/2015

 Oxybutynin (PDF - 35KB) 

DraftTransdermalGel, metered2025136/2015

 Oxycodone hydrochloride (PDF - 42KB)

DraftOralCapsule2005346/2015

 Primaquine phosphate (PDF - 25KB)

DraftOralTablet0083166/2015

 Sildenafil citrate (PDF - 42KB)

DraftOralSuspension2031096/2015

 Simeprevir sodium (PDF - 39KB) 

DraftOralCapsule2051236/2015

 Sofosbuvir (PDF - 23KB)

DraftOralTablet2046716/2015

 Tolcapone (PDF - 39KB)

DraftOralTablet0206976/2015

 Vemurafenib (PDF - 40KB)

DraftOralTablet2024296/2015

 Vismodegib (PDF - 62KB)

DraftOralCapsule2033886/2015

 Vortioxetine hydrobromide (PDF - 23KB)

DraftOralTablet2044476/2015

 

Newly Revised Bioequivalence Recommendations Mar. 2015 

Active Ingredient
(link to Specific Guidance)
TypeRoute of AdministrationDosage FormRLD Application Number
(link to Orange Book)
Date Recommended
 
Cholestyramine (PDF - 168KB) Revised DraftOralPowder

74557

74558

6/2015
Doxycycline Hyclate (PDF-19KB) RevisedDraftOralTablet, Delayed Release507956/2014
Prasugrel HCl (PDF - 37 KB) RevisedDraftOralTablet223076/2015
Tiagabine HCl (PDF - 39KB) RevisedDraftOralTablet206466/2015

 

 

Page Last Updated: 07/01/2015
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