Drugs

Product-Specific Guidances 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 to 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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (Dec. 2013).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 the generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support ANDA approval, FDA publishes product-specific guidances describing  the Agency’s current thinking and expectations on how to develop generic drug products therapeutically equivalent to specific reference-listed drugs.  

These guidances are published in an incremental manner and listed below in alphabetical order according to RLD’s name. The most recently published guidances (new and revised) are listed below.

Some of the CDER OGD Product Specific Guidances include discussion regarding data formats. Please note that under section 745A(a) of the Food, Drug & Cosmetic Act, separate Agency-wide guidances specify the electronic formats, subject matter, and scope of applicability for certain submissions, including submissions to ANDAs. As these are finalized guidances and subject to described timetables for implementation, these guidances are binding and the electronic format(s) specified must be used for submissions to ANDAs. Questions and general information regarding the preparation of submissions in electronic format may be directed to CDER at esub@fda.hhs.gov. Questions regarding submission of datasets to CDER may be sent to edata@fda.hhs.gov.

The Agency is seeking feedback and considers comments to the docket on these guidances. 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  

Product-Specific Guidances Arranged by Active Ingredient

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 Guidances since May 1, 2017 (21 New; 16 Revisions) updated  5/15/2017

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

Acetylcysteine  (PDF - 37KB)

 DraftOral

Tablets, Effervescent

2079165/2017

Amphetamine (PDF - 59KB)

 Draft Oral

Tablets,  Extended Release orally disintegrating

2043265/2017

Aprepitant (PDF - 38KB)

 DraftOralSuspension2078655/2017

Azelastine hydrochloride  (PDF - 36KB)

DraftnasalSpray, metered201145/2017

Bisacodyl; Polyethylene Glycol 3350; Potassium Chloride;  Sodium Bicarbonate; Sodium Chloride (PDF - 39KB)

DraftOralTablet, Delayed Release for Solution2022175/2017

Carbidopa; levodopa (PDF - 49KB)

DraftEnteralSuspension2039525/2017

Chlordiazepoxide hydrochloride; clidinium bromide (PDF - 40KB)

DraftOralCapsule0127505/2017

Clonazepam (PDF - 39KB)

DraftOralTablets, disintegrating0771715/2017

Edoxaban tosylate (PDF - 63KB)

Draft OralTablet2063165/2017

Gentamicin sulfate (PDF -38KB)/p>

DraftTopicalOintment0623515/2017

Hydrocortisone butyrate (PDF - 35KB) 

DraftTopicalLotion0220765/2017

Hydrocortisone (PDF - 37KB)

DraftTopicalCream0894145/2017

Linagliptin; Metformin hydrochloride (PDF - 44KB)

DraftOralTablet, Extended Release2080265/2017

Lorcaserin HCl - 37KB)

Draft

 Oral

Tablet, Extended Release

208524

5/2017

Methylnaltrexone bromide (PDF - 38 KB)

DraftOralTablet2082715/2017

Nitroglycerin (PDF - 61KB)

DraftSublingualPowder2084245/2017

Nystatin and Triamcinolone acetonide (PDF - 91KB)

DraftTopicalCream0623645/2017

Nystatin and Triamcinolone acetonide (PDF - 33KB)

DraftTopicalOintment0633055/2017

Tetracaine hydrochloride; Oxymetazoline hydrochloride (PDF - 42KB)

DraftNasalSpray2080325/2017

Sofosbuvir; velpatasvir  (PDF - 39KB)

DraftOralTablet2083415/2017

Venetoclax  (PDF - 40KB)

DraftOralTablet2085735/2017
 

Newly Revised Guidances since May 1, 2017

Active Ingredient
(link to Specific Guidance)
TypeRoute of AdministrationDosage FormRLD Application Number
(link to Orange Book)
Date Recommended
Acamprosate Calcium (PDF - 76 KB) RevisedDraft OralTablet, Delayed Release

21431

202229

5/2017

Apixaban (PDF - 22KB) Revised

 Draft OralTablet2021555/2017
Bexarotene (PDF - 46KB) RevisedDraftOralCapsule210555/2017
Calcium Acetate (PDF - 16KB)RevisedDraftOralTablet785025/2017
Calcium Acetate (PDF - 16KB)RevisedDraftOralCapsule211605/2017

Deferiprone (PDF - 40KB) Revised

DraftOralTablet0218255/2017

Dolutegravir sodium (PDF - 39KB) Revised

Draft OralTablet2047905/2017

Emtricitabine; Tenofovir disoproxil fumarate (PDF - 23KB) Revised

DraftOralTablet217525/2017
Fingolimod (PDF - 36KB) RevisedDraftOralCapsule225275/2017
Lanthanum Carbonate (PDF - 45KB) RevisedDraftOralTablets, Chewable214685/2017
Nevirapine (PDF - 51KB) Revised DraftOralTablet206365/2017
Phenytoin (PDF - 18KB) RevisedDraftOralTablet, Chewable844275/2017
Phenytoin (PDF - 20KB) RevisedDraftOralSuspension087625/2017
Propafenone HCl (PDF - 28KB) RevisedDraftOralCapsule, Extended Release214165/2017
Trospium Chloride (PDF - 23KB) RevisedDraftOralCapsule, Extended Release

22103 

91289

5/2017
Trospium Chloride (PDF - 36KB) RevisedDraftOralTablet

21595

91575

5/2017

 

 

Page Last Updated: 05/23/2017
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