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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: 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 1277]
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 - March 2015 (38 New) 22 Revisions updated 5/5/2015

Active Ingredient
(link to Specific Guidance)
TypeRoute of AdministrationDosage FormRLD Application Number
(link to Orange Book)
Date Recommended
 
Avanafil (PDF - 40KB) Draft OralTablet2022763/2015
Azilsartan kamedoxomil; chlorthalidone (PDF - 54KB) Draft Oral

 Tablet

Capsule

2023313/2015

 Buprenorphine HCl; Naloxone HCl (PDF -60KB)

 Draft BuccalFilm2056373/2015

 Chlorpheniramine maleate; Ibuprofen; Phenylephrine hydrochloride (PDF - 23KB)

DraftOralTablet0221133/2015
the word new in a red boxClozapine (PDF - 22 KB)FinalOralTablet, Orally Disintegrating197585/5/2015
Cyclosporine (PDF - 40KB)DraftOralCapsule0506253/2015
Cyclosporine (PDF - 40KB)DraftOralCapsule (modified)0507153/2015

 Deferiprone (PDF - 40KB)

DraftOralTablet0218253/2015

 Desoximetasone  (PDF - 23KB)

Draft TopicalSpray2041413/2015

 Diclofenac  (PDF - 23KB)

DraftOralCapsule2045923/2015
 

Diphenhydramine HCl; naproxen sodium (PDF - 23KB) 

DraftOralTablet2053523/2015

 Dorzolamide HCl (PDF - 84KB)

DraftOphthalmicSolution/drops204083/2015

 Doxepin HCl (PDF - 40KB)

DraftOralCapsule0716693/2015

 Emtricitabine, rilpivirine hydrochloride, tenofovir disoproxil fumarate (PDF - 42KB)

Draft OralTablet2021233/2015

 Fluocinolone acetonide, hydroquinone, and tretinoin (PDF - 110KB)

DraftTopicalCream211123/2015
 

Ibrutinib (PDF - 23KB)

DraftOralCapsule2055523/2015

 Ibuprofen (PDF - 39KB)

DraftOralCapsule0204023/2015

 Ipratropium bromide (PDF - 95KB)

DraftInhalationAerosol, metered0215273/2015

 Isosorbide dinitrate  (PDF - 59KB)

DraftOralTablet0120933/2015

 Isosorbide dinitrate (PDF - 59KB)

DraftOralTablet0879463/2015

 Isotretinoin (PDF - 45KB)

Draft OralCapsule0219513/2015

 Ivacaftor (PDF - 39KB)

DraftOralTablet2031883/2015

 Loperamide HCl (PDF - 41KB) 

DraftOralTablet, Chewable204483/2015

 Loperamide HCl (PDF - 41KB) 

DraftOralCapsule0218553/2015

 Loperamide HCl (PDF - 41KB) 

DraftOralCapsule176943/2015

 Loperamide HCl (PDF - 40KB)

DraftOralSuspension194873/2015

 Loperamide HCl (PDF - 41KB) 

DraftOralTablet198603/2015

 Lorcaserin HCl(PDF - 42KB) 

DraftOralTablet225293/2015

 Minocycline HCl (PDF - 113KB) 

DraftDentalPowder, Extended Release507813/2015

 Oxybutynin chloride (PDF - 42KB)

DraftOralTablet0750793/2015

 

Potassium chloride (PDF - 37KB) 
DraftOralTablet, Extended Release0182793/2015

 Praziquantel (PDF - 42KB) 

DraftOralTablet187143/2015

 Pyrimethamine  (PDF - 22KB) 

DraftOralTablet0085783/2015

 Sodium polystyrene sulfonate  (PDF - 16KB) 

DraftOral/RectalPowder0112873/2015

 

Sucroferric oxyhydroxide (PDF - 26KB)  
DraftOralTablet, Chewable2051093/2015

 Ticagrelor (PDF - 41KB) 

DraftOralTablet0224333/2015

 Topiramate (PDF - 27KB) 

DraftOralCapsule, Extended Release2051223/2015

  Topiramate  (PDF - 25KB) 

DraftOralCapsule, Extended Release2016353/2015

 Vigabatrin  (PDF - 42KB)

DraftOralTablet204273/2015

 

Newly Revised Bioequivalence Recommendations Mar. 2015 

Active Ingredient
(link to Specific Guidance)
TypeRoute of AdministrationDosage FormRLD Application Number
(link to Orange Book)
Date Recommended
 
Brimonidine Tartrate (PDF - 86KB) RevisedDraftOphthalmicSolution/Drops 0.1%

21770

3/2015
Brimonidine Tartrate (PDF - 87KB) RevisedDraftOphthalmicSolution/Drops 0.2%

76260

3/2015
Brimonidine Tartrate (PDF - 87KB) RevisedDraftOphthalmicSolution/Drops 0.15%

21262

3/2015
Brimonidine tartrate; Brinzolamide (PDF - 85KB)RevisedDraft OphthalmicDrops, Suspension2042513/2015

Brinzolamide (PDF - 85KB) Revised

DraftOphthalmicSuspension/Drops 1%

20816

3/2015

Budesonide (PDF - 39KB)

DraftOralCapsule

21324

3/2015
Carbamazepine (PDF - 19KB) RevisedDraftOralTablet, Extended Release202343/2015
Carbamazepine (PDF - 42KB) RevisedDraftOralCapsule, Extended Release207123/2015
Carbamazepine(PDF - 42KB) RevisedDraftOralSuspension189273/2015
Ciprofloxacin; Dexamethasone (PDF - 149KB RevisedDraft OticSuspension/Drops215373/2015
Dexmethylphenidate HCl (PDF - 130KB) Revised Draft OralCapsule, Extended Release218023/2015
Dextroamphetamine Sulfate (PDF-18KB) RevisedDraftOralCapsule, Extended Release170783/2015
Doxepin HCl (PDF - 35KB) RevisedDraftOralCapsule

70791

3/2015
Eltrombopag Olamine (PDF -41KB) RevisedFinalOralTablet00222913/2015
Gabapentin (PDF - 14KB) RevisedDraft OralTablet225443/2015
Isotretinoin (PDF - 29KB) RevisedDraftOralCapsule761353/2015
Methylphenidate HCl (PDF - 50KB) Revised DraftOralCapsules, Extended Release212843/2015

Mirtazapine (PDF - 49KB) Revised

DraftOralTablet204153/2015
Nisoldipine (PDF - 42KB)
Revised
DraftOralTablet, Extended Release0203563/2015
Oseltamivir Phosphate (PDF - 16KB) RevisedDraftOralSuspension212463/2015
Paliperidone (PDF - 19KB) RevisedDraftOralTablet, Extended Release219993/2015
Teriflunomide (PDF - 35KB) RevisedDraftOralTablet2029923/2015

 

 

Page Last Updated: 05/05/2015
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