FDA seeks input on product-specific guidances to facilitate generic drug development

Guidances (Drugs) > Product-Specific Recommendations for Generic Drug Development

FDA has published 48 product-specific guidances (31 new and 17 revised) describing the Agency’s current thinking and expectations on how to develop generic drug products that are therapeutically equivalent to specific reference-listed drugs.

FDA always seeks feedback and considers all comments to the docket before it begins work on the final versions of product-specific guidances.

For more information and to view the guidances, visit http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/guidances/ucm075207.htm 

Product-Specific Recommendations for Generic Drug Development

Guidances (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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (Dec. 2013).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 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 Biopharmaceutics  

Bioequivalence Recommendations for Specific Products 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 Recommendations since Dec. 1, 2016 (31 New; 17 Revisions) updated 12/22/2016

Active Ingredient (link to Specific Guidance)	Type	Route of Administration	Dosage Form	RLD Application Number (link to Orange Book)	Date Recommended
Adapalene; Benzoyl peroxide (PDF - 159KB)	Draft	Topical	Gel	207917	12/2016
Amphetamine (PDF - 71KB)	Draft	Oral	Suspension, Extended Release	208147	12/2016
Betamethasone valerate (PDF - 35KB)	Draft	Topical	Cream	018861	12/2016
Budesonide (PDF - 107KB)	Draft	Inhalation	Powder	21949	12/2016
Cephalexin (PDF - 37KB)	Draft	Oral	Suspension	062703	12/2016
Cetirizine hydrochloride (PDF - 40KB)	Draft	Oral	Tablet	019835	12/2016
Clozapine (PDF - 70KB)	Draft	Oral	Suspension	203479	12/2016
Colchicine (PDF - 38KB)	Draft	Oral	Capsule	204820	12/2016
Doxycycline hyclate (PDF - 38KB)	Draft	Oral	Capsule	208253	12/2016
Emtricitabine; Rilpivirine hydrochloride; Tenofovir alafenamide fumarate (PDF - 25KB)	Draft	Oral	Tablet	208351	12/2016
Emtricitabine; Tenofovir alafenamide fumarate (PDF - 39KB)	Draft	Oral	Tablet	208215	12/2016
Epinephrine (PDF - 54KB)	Draft	Intramuscular, subcutaneous	Injection	19430	12/2016
Esomeprazole magnesium (PDF - 69KB)	Draft	Oral	Capsule, Delayed Release	204655	12/2016
Ethiodized oil (PDF - 43KB)	Draft	intralymphatic,  intrauterine,  selective hepatic intra-arterial	Injectable	009190	12/2016
Fenofibrate (PDF - 39KB)	Draft	Oral	Capsule	021695	12/2016
Fluocinonide (PDF - 35KB)	Draft	Topical	Cream	21758	12/2016
Fluoxetine HCl (PDF - 59KB)	Draft	Oral	Tablet	202133	12/2016
Halcinonide (PDF - 35KB)	Draft	Topical	Cream	017556	12/2016
Ibuprofen; Pseudoephedrine HCl (PDF - 39KB)	Draft	Oral	Capsule	21374	12/2016
Lidocaine (PDF - 39KB)	Draft	Topical	Ointment	080198	12/2016
Morphine sulfate (PDF - 43KB)	Draft	Oral	Tablet, Extended Release	206544	12/2016
Nicotine polacrilex (PDF - 41KB)	Draft	Oral	Troche/lozenge	21330	12/2016
Nitisinone (PDF - 59KB)	Draft	Oral	Suspension	206356	12/2016
Omega-3-acid Ethyl Esters Type A (PDF - 93KB)	Draft	Oral	Capsule	204977	12/2016
Oxycodone (PDF - 54KB)	Draft	Oral	Capsule, Extended Release	208090	12/2016
Panobinostat lactate (PDF - 41KB)	Draft	Oral	Capsule	205353	12/2016
Perampanel (PDF - 61KB)	Draft	Oral	Suspension	208277	12/2016
Pimavanserin tartrate (PDF - 63KB)	Draft	Oral	Tablet	207318	12/2016
Prazosin HCl (PDF - 39KB)	Draft	Oral	Capsule	17442	12/2016
Simvastatin (PDF - 39KB)	Draft	Oral	Suspension	206679	12/2016
Tofacitinib citrate (PDF - 39KB)	Draft	Oral	Tablet, Extended Release	208246	12/2016

Newly Revised Bioequivalence Recommendations since Dec. 1, 2016

Active Ingredient (link to Specific Guidance)	Type	Route of Administration	Dosage Form	RLD Application Number (link to Orange Book)	Date Recommended
Acyclovir  (PDF - 85KB) Revised	Draft	Topical	Cream, 5%	021478	12/2016
Albuterol Sulfate (PDF - 144KB) Revised	Draft	Inhalation	Aerosol, Metered	20503 20983 21457	12/2016
Buprenorphine HCl; Naloxone HCl (PDF - 26KB) Revised	Draft	Sublingual	Film	022410	12/2016
Buprenorphine HCl; Naloxone HCl (PDF - 23KB)  Revised	Draft	Oral	Tablet, Sublingual	204242	12/2016
Cobicistat; darunavir ethanolate  (PDF -39KB) Revised	Draft	Oral	Tablet	205395	12/2016
Divalproex Sodium (PDF-19KB) Revised	Draft	Oral	Tablet, Delayed Release	18723	12/2016
Divalproex Sodium (PDF-19KB) Revised	Draft	Oral	Capsule, Delayed Release Pellets	19680	12/2016
Divalproex Sodium (PDF-57KB) Revised	Draft	Oral	Tablet, Extended Release	21168	12/2016
Levomilnacipran HCl (PDF - 25KB) Revised	Draft	Oral	Capsule, Extended Release	204168	12/2016
Medroxyprogesterone Acetate (PDF - 24KB Revised	Draft	Intramuscular	Suspension	020246	12/2016
Nepafenac (PDF - 73KB) Revised	Draft	Ophthalmic	Drops, Suspension 0.1%	21862	12/2016
Nepafenac (PDF - 78KB)  Revised	Draft	Ophthalmic	Drops, Suspension 0.3%	203491	12/2016
Omega-3 Carboxylic Acids (PDF - 84KB)Revised	Draft	Oral	Capsule	205060	12/2016
Omega-3-Acid Ethyl Esters (PDF - 82KB)  Revised	Draft	Oral	Capsule	21654	12/2016
Ruxolitinib phosphate (PDF - 39KB) Revised	Draft	Oral	Tablet	202192	12/2016
Tedizolid phosphate (PDF - 23KB) Revised	Draft	Oral	Tablet	205435	12/2016
Venlafaxine HCl (PDF - 28KB) Revised	Draft	Oral	Tablet	76690	12/2016

Resources

• Drug-Related Guidances
• Bioequivalence Recommendations for Specific Products (PDF - 80KB) 
  (updated 6/2010)
• Dissolution Methods Database
• Withdrawn CDER Bioequivalence Recommendations (PDF - 53KB) 
  (updated 12/22/2016)