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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (Dec. 2013).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 [Total count 1554]
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 Dec. 1, 2016 (31 New; 18 Revisions) updated  2/14/2017

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

 Adapalene; Benzoyl peroxide (PDF - 159KB)

 DraftTopical

Gel

20791712/2016

 Amphetamine (PDF - 71KB) 

 Draft Oral

Suspension, Extended Release

20814712/2016

 Betamethasone valerate (PDF - 35KB) 

 DraftTopicalCream01886112/2016

 Budesonide (PDF - 107KB)

DraftInhalationPowder2194912/2016

 Cephalexin (PDF - 37KB)

DraftOralSuspension06270312/2016

 Cetirizine hydrochloride (PDF - 40KB)

DraftOralTablet01983512/2016

 Clozapine (PDF - 70KB)

DraftOralSuspension20347912/2016
 

Colchicine (PDF - 38KB)

DraftOralCapsule20482012/2016

 Doxycycline hyclate (PDF - 38KB)

Draft OralCapsule20825312/2016

 Emtricitabine; Rilpivirine hydrochloride; Tenofovir alafenamide fumarate (PDF - 25KB)

DraftOralTablet20835112/2016

 

Emtricitabine; Tenofovir alafenamide fumarate (PDF - 39KB)

 

DraftOralTablet20821512/2016

 Epinephrine (PDF - 54KB)

DraftIntramuscular, subcutaneousInjection1943012/2016

 Esomeprazole magnesium (PDF - 69KB)

DraftOralCapsule, Delayed Release20465512/2016

 Ethiodized oil (PDF - 43KB)

Draft

 intralymphatic,
intrauterine,
selective hepatic intra-arterial

Injectable

009190

12/2016

 Fenofibrate (PDF - 39KB)

DraftOralCapsule02169512/2016

 Fluocinonide (PDF - 35KB)

DraftTopicalCream2175812/2016

 Fluoxetine HCl (PDF - 59KB)

DraftOralTablet20213312/2016

 Halcinonide (PDF - 35KB)

DraftTopicalCream01755612/2016

Ibuprofen; Pseudoephedrine HCl (PDF - 39KB) 

DraftOralCapsule2137412/2016

 Lidocaine (PDF - 39KB)

DraftTopicalOintment08019812/2016

 Morphine sulfate (PDF - 43KB)

DraftOralTablet, Extended Release20654412/2016

 Nicotine polacrilex (PDF - 41KB)

DraftOralTroche/lozenge2133012/2016

 Nitisinone (PDF - 59KB)

DraftOralSuspension20635612/2016

Omega-3-acid Ethyl Esters Type A (PDF - 93KB)

DraftOralCapsule20497712/2016

 Oxycodone (PDF - 54KB)  

DraftOralCapsule, Extended Release20809012/2016

 Panobinostat lactate (PDF - 41KB)

DraftOralCapsule20535312/2016

 Perampanel (PDF - 61KB)

DraftOralSuspension20827712/2016

 Pimavanserin tartrate (PDF - 63KB)

DraftOralTablet20731812/2016

 Prazosin HCl (PDF - 39KB)

DraftOralCapsule1744212/2016

 Simvastatin (PDF - 39KB)

DraftOralSuspension20667912/2016

 Tofacitinib citrate (PDF - 39KB)

DraftOralTablet, Extended Release20824612/2016

 

Newly Revised Bioequivalence Recommendations since Dec. 1, 2016

Active Ingredient
(link to Specific Guidance)
TypeRoute of AdministrationDosage FormRLD Application Number
(link to Orange Book)
Date Recommended
Acyclovir  (PDF - 85KB) Revised Draft TopicalCream, 5%02147812/2016

 

Albuterol Sulfate (PDF - 144KB) Revised

 Draft InhalationAerosol, Metered

20503

20983

21457

 12/2016

Buprenorphine HCl; Naloxone HCl (PDF - 26KB) Revised

Draft SublingualFilm02241012/2016
Buprenorphine HCl; Naloxone HCl (PDF - 23KB)  Revised DraftOralTablet, Sublingual20424212/2016
  

Cobicistat; darunavir ethanolate  (PDF -39KB) Revised

DraftOralTablet20539512/2016

 Difluprednate (PDF - 57KB) Revised

DraftOphthalmicEmulsion0222122/2017
Divalproex Sodium (PDF-19KB) RevisedDraftOralTablet, Delayed Release1872312/2016
Divalproex Sodium (PDF-19KB) RevisedDraftOralCapsule, Delayed Release Pellets1968012/2016
Divalproex Sodium (PDF-57KB) RevisedDraftOralTablet, Extended Release2116812/2016

 Levomilnacipran HCl (PDF - 25KB) Revised

DraftOralCapsule, Extended Release20416812/2016

 Medroxyprogesterone Acetate (PDF - 24KB Revised

Draft IntramuscularSuspension02024612/2016
Nepafenac (PDF - 73KB) RevisedDraftOphthalmicDrops, Suspension 0.1%2186212/2016
Nepafenac (PDF - 78KB)  RevisedDraftOphthalmicDrops, Suspension 0.3%20349112/2016

Omega-3 Carboxylic Acids (PDF - 84KB)Revised

DraftOralCapsule20506012/2016
Omega-3-Acid Ethyl Esters (PDF - 82KB)  RevisedDraft OralCapsule2165412/2016

 Ruxolitinib phosphate (PDF - 39KB) Revised

DraftOralTablet2021921/2017

 Tedizolid phosphate (PDF - 23KB) Revised

DraftOralTablet20543512/2016
Venlafaxine HCl (PDF - 28KB) RevisedDraftOralTablet7669012/2016

 

 

Page Last Updated: 02/14/2017
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English