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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (Dec. 2013).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 July 1, 2017 (21 New; 13 Revisions; 48 Finalized) updated  8/4/2017

Active Ingredient
(link to Specific Guidance)
Type Route of Administration Dosage Form RLD Application Number
(link to Orange Book)
Date Recommended
 

Aspirin; Omeprazole (PDF - 46 KB

 Draft Oral

Tablets, Delayed release

205103 7/2017

Aspirin (PDF - 42KB)

 Draft  Oral

Capsule,  Extended Release

200671 7/2017

Brexpiprazole (PDF - 39KB)

 Draft Oral Tablet 205422 7/2017

Brivaracetam  (PDF - 41KB)

Draft Oral Tablet 205836 7/2017

Cefdinir (PDF - 38KB)

Draft Oral Powder for Suspension 050749 7/2017

Clocortolone pivalate (PDF - 35KB)

Draft Topical Cream 017765 7/2017

Cyanocobalamin (PDF - 45KB)

Draft Nasal Spray 021642 7/2017

Dasabuvir Sodium; Ombitasvir; Paritaprevir; Ritonavir (PDF - 42KB)

Draft Oral Tablets, Extended Release 208624 7/2017

Dextroamphetamine sulfate (PDF -38KB)

Draft Oral Tablet 040361 7/2017

Diclofenac sodium (PDF - 60KB) 

Draft Topical Solution 204623 7/2017

Fluphenazine HCl (PDF - 41KB)

Draft Oral Tablet 089804 7/2017

Gentamicin sulfate (PDF - 38KB)

Draft Topical Cream 062307 7/2017

Glycopyrrolate (PDF - 123KB)

Draft

Inhalation

Powder

207923

7/2017

Obeticholic Acid (PDF - 41 KB)

Draft Oral Tablet 207999 7/2017

Silver sulfadiazine (PDF - 72KB)

Draft Topical Cream 017381 7/2017

Tenofovir alafenamide fumarate(PDF - 40KB)

Draft Oral Tablet 208464 7/2017

Tiopronin (PDF - 38KB)

Draft Oral Tablet 19569 7/2017

Trifluridine; Tipiracil (PDF - 41KB)

Draft Oral Tablet 207981 7/2017

Triamcinolone acetonide (PDF - 32KB)

Draft Topical Lotion 011602 7/2017

Triamcinolone acetonide  (PDF - 33KB)

Draft Topical Ointment 087356 7/2017

Uridine triacetate (PDF - 47KB)

Draft Oral Granules

208159

208169

7/2017
 

Newly Revised Guidances since July 1, 2017

Active Ingredient
(link to Specific Guidance)
Type Route of Administration Dosage Form RLD Application Number
(link to Orange Book)
Date Recommended
 
Brimonidine Tartrate (PDF - 87KB) Revised Draft Ophthalmic Solution/Drops

21262

7/2017
Dabigatran Etexilate Mesylate (PDF - 42KB) Revised  Draft  Oral Capsule 22512  7/2017

Dorzolamide HCl (PDF - 84KB) Revised

Draft Ophthalmic Solution/drops 20408 7/2017

Gefitinib (PDF - 39KB) Revised

Draft Oral Tablet 206995 7/2017
Latanoprost (PDF - 14KB) Revised Draft Ophthalmic Solution 20597 7/2017
Methoxsalen (PDF - 24KB) Revised Draft Oral Capsule 19600 7/2017
Metoprolol tartrate (PDF - 22KB) Revised Draft Oral Tablet 076704 7/2017
Minocycline HCl (PDF - 15KB) Revised Draft Oral Capsule

63009

63011

7/2017
Minocycline HCl (PDF - 29KB) Revised Draft Oral Tablet 50451 7/2017
Minoxidil (PDF - 15KB)
Revised
Draft Oral Tablet 71344
71345
7/2017
Pimozide (PDF - 18KB) Revised Draft Oral Tablet 17473 7/2017
Propafenone HCl (PDF - 35KB) Revised Draft Oral Tablet 19151 7/2017
Tetrabenazine (PDF - 46KB) Revised Draft  Oral Tablet 21894  7/2017

Newly Finalized Guidances since August 4, 2017

 

Active Ingredient
(link to Specific Guidance)
Type Route of Administration Dosage Form RLD Application Number
(link to Orange Book)
Date Recommended
 
Acarbose (PDF - 37 KB) Final Oral Tablet 20482 8/2017
Acetaminophen; Butalbital; Caffeine; Codeine phosphate (PDF - 20KB) Final  Oral

 

Capsule

20232 8/2017
Acetaminophen; Aspirin; Caffeine (PDF - 20KB) Final  Oral Tablet 020802 8/2017
Acitretin (PDF - 131 KB)  Final Oral Capsule 19821 8/2017

Amoxicillin; Clavulanate Potassium (PDF - 33KB)

Final Oral Tablet

50720

50564

8/2017

Amoxicillin (PDF - 23KB)

Final Oral Suspension

50460

8/2017

Amoxicillin (PDF - 23KB)

Final Oral Suspension 065119 8/2017
Aspirin; Butalbital; Caffeine (PDF-17 KB) Final Oral Capsule 17534 8/2017
Aspirin; Butalbital; Caffeine (PDF-17 KB) Final Oral Tablet 17534 8/2017
Aspirin; Butalbital; Caffeine; Codeine Phosphate (PDF - 16 KB) Final Oral Capsule 19429 8/2017
Atenolol (PDF - 16 KB) Final Oral Tablet 18240 8/2017

Atenolol and Chlorthalidone (PDF - 22KB)

Final Oral Tablet

018760

8/2017
Cetirizine Hydrochloride (PDF - 34KB) Final Oral Capsule 22429 8/2017
Chlorthalidone (PDF - 36 KB) Final Oral Tablet

12283

8/2017
Citalopram HBr (PDF - 16KB) Final Oral Capsule 77668 8/2017
Citalopram HBr (PDF - 21KB) Final Oral Tablet 20822 8/2017
Clarithromycin (PDF - 15KB) Final Oral Tablet 50662 8/2017
Clindamycin HCL (PDF -31KB) Final Oral Capsule 50162 8/2017
Clomiphene Citrate (PDF - 33KB) Final  Oral Tablet 16131 8/2017
Clonazepam (PDF - 16KB) Final Oral Tablet 17533 8/2017
Clozapine (PDF - 22 KB) Final Oral Tablet, Orally Disintegrating 21590 8/2017
Cyclobenzaprine HCl (PDF - 25KB) Final Oral Tablet 17821 8/2017

Cycloserine (PDF -22KB)  

Final Oral Capsule

60593

8/2017
Dapsone (PDF - 33KB) Final Oral Tablet

86841 

86842

8/2017
Desipramine HCl (PDF -22KB) Final Oral Tablet

14399

8/2017
Desmopressin Acetate (PDF-33KB) Final Oral Tablet 19955 8/2017
Diflunisal (PDF-15KB)  Final Oral Tablet 18445 8/2017
Diphenhydramine HCl (PDF -23KB) Final Oral Capsule. 080738 8/2017
Dipyridamole (PDF-41KB) Final Oral Tablet 12836 8/2017
Disulfiram (PDF - 26 KB) Final Oral Tablet

007883

8/2017
Donepezil HCl (PDF - 49KB) Final Oral Tablet 22568 8/2017
Doxazosin Mesylate (PDF - 35KB) Final Oral Tablet 19668 8/2017

Doxepin HCl (PDF - 40KB)

Final Oral Capsule 16798 8/2017
Doxercalciferol (PDF-30KB)
Final Oral Capsule 20862 8/2017
Eprosartan Mesylate (PDF - 16KB) Final Oral Tablet 20738 8/2017
Ethambutol HCl (PDF - 18KB) Final Oral Tablet 16320 8/2017
Hydrochlorothiazide; Triamterene (PDF - 18KB) Final Oral Capsule

16042

73191

8/2017
Hydrochlorothiazide; Losartan Potassium (PDF - 113KB) Final Oral Tablet 20387 8/2017
Hydrochlorothiazide; Valsartan (PDF - 41KB)
Final Oral Tablet 20818 8/2017
Hydrocodone bitartrate; Ibuprofen (PDF - 18KB) Final Oral Tablet 020716 8/2017
Hydrocortisone (PDF - 22KB) Final Oral Tablet 08697 8/2017
Hydromorphone HCl (PDF - 16KB) Final Oral Tablet 19892 8/2017
Selegiline hydrochloride (PDF - 49KB) Final Oral Capsule 020647 8/2017

Sotalol HCl (PDF - 39KB)

Final Oral Tablet 21151 8/2017
Tenofovir Disoproxil Fumarate (PDF - 17KB)  Final Oral Tablet 21356 8/2017
Tiagabine HCl (PDF - 39KB)  Final Oral Tablet 20646 8/2017
Valproic Acid (PDF - 26KB) Final Oral Capsule 18081 8/2017
Verapamil HCl (PDF - 16KB) Final Oral Tablet 18817 8/2017

 

 

Page Last Updated: 08/15/2017
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