martes, 8 de agosto de 2017

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

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

FDA has published 48 finalized product-specific guidances 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.

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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (Dec. 2013).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 Questions regarding submission of datasets to CDER may be sent to
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 OR mail your written comments to DDM (HFA-305), FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Please contact the 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)
TypeRoute of AdministrationDosage FormRLD Application Number
(link to Orange Book)
Date Recommended
Tablets, Delayed release
 Draft Oral
Capsule,  Extended Release
DraftOralPowder for Suspension0507497/2017
DraftOralTablets, Extended Release2086247/2017

Newly Revised Guidances since July 1, 2017

Active Ingredient
(link to Specific Guidance)
TypeRoute of AdministrationDosage FormRLD Application Number
(link to Orange Book)
Date Recommended
Brimonidine Tartrate (PDF - 87KB) RevisedDraftOphthalmicSolution/Drops7/2017
Dabigatran Etexilate Mesylate (PDF - 42KB) Revised Draft OralCapsule22512 7/2017
Latanoprost (PDF - 14KB) RevisedDraftOphthalmicSolution205977/2017
Methoxsalen (PDF - 24KB) RevisedDraftOralCapsule196007/2017
Metoprolol tartrate (PDF - 22KB) RevisedDraftOralTablet0767047/2017
Minocycline HCl (PDF - 15KB) RevisedDraftOralCapsule7/2017
Minocycline HCl (PDF - 29KB) RevisedDraftOralTablet504517/2017
Minoxidil (PDF - 15KB)RevisedDraftOralTablet71344713457/2017
Pimozide (PDF - 18KB) RevisedDraftOralTablet174737/2017
Propafenone HCl (PDF - 35KB) RevisedDraftOralTablet191517/2017
Tetrabenazine (PDF - 46KB) RevisedDraft OralTablet21894 7/2017

Newly Finalized Guidances since August 4, 2017

Active Ingredient
(link to Specific Guidance)
TypeRoute of AdministrationDosage FormRLD Application Number
(link to Orange Book)
Date Recommended
Acarbose (PDF - 37 KB)FinalOralTablet204828/2017
Acetaminophen; Butalbital; Caffeine; Codeine phosphate (PDF - 20KB)Final Oral

Acetaminophen; Aspirin; Caffeine (PDF - 20KB)Final OralTablet0208028/2017
Acitretin (PDF - 131 KB) FinalOralCapsule198218/2017
Aspirin; Butalbital; Caffeine (PDF-17 KB)FinalOralCapsule175348/2017
Aspirin; Butalbital; Caffeine (PDF-17 KB)FinalOralTablet175348/2017
Aspirin; Butalbital; Caffeine; Codeine Phosphate (PDF - 16 KB)FinalOralCapsule194298/2017
Atenolol (PDF - 16 KB)FinalOralTablet182408/2017
Cetirizine Hydrochloride (PDF - 34KB)FinalOralCapsule224298/2017
Chlorthalidone (PDF - 36 KB)FinalOralTablet8/2017
Citalopram HBr (PDF - 16KB)FinalOralCapsule776688/2017
Citalopram HBr (PDF - 21KB)FinalOralTablet208228/2017
Clarithromycin (PDF - 15KB)FinalOralTablet506628/2017
Clindamycin HCL (PDF -31KB)FinalOralCapsule501628/2017
Clomiphene Citrate (PDF - 33KB)Final OralTablet161318/2017
Clonazepam (PDF - 16KB)FinalOralTablet175338/2017
Clozapine (PDF - 22 KB)FinalOralTablet, Orally Disintegrating215908/2017
Cyclobenzaprine HCl (PDF - 25KB)FinalOralTablet178218/2017
Dapsone (PDF - 33KB)FinalOralTablet8/2017
Desipramine HCl (PDF -22KB)FinalOralTablet8/2017
Desmopressin Acetate (PDF-33KB)FinalOralTablet199558/2017
Diflunisal (PDF-15KB) FinalOralTablet184458/2017
Diphenhydramine HCl (PDF -23KB)FinalOralCapsule.0807388/2017
Dipyridamole (PDF-41KB)FinalOralTablet128368/2017
Disulfiram (PDF - 26 KB)FinalOralTablet8/2017
Donepezil HCl (PDF - 49KB)FinalOralTablet225688/2017
Doxazosin Mesylate (PDF - 35KB)FinalOralTablet196688/2017
Doxercalciferol (PDF-30KB)FinalOralCapsule208628/2017
Eprosartan Mesylate (PDF - 16KB)FinalOralTablet207388/2017
Ethambutol HCl (PDF - 18KB)FinalOralTablet163208/2017
Hydrochlorothiazide; Triamterene (PDF - 18KB)FinalOralCapsule8/2017
Hydrochlorothiazide; Losartan Potassium (PDF - 113KB)FinalOralTablet203878/2017
Hydrochlorothiazide; Valsartan (PDF - 41KB)
Hydrocodone bitartrate; Ibuprofen (PDF - 18KB)FinalOralTablet0207168/2017
Hydrocortisone (PDF - 22KB)FinalOralTablet086978/2017
Hydromorphone HCl (PDF - 16KB)FinalOralTablet198928/2017
Selegiline hydrochloride (PDF - 49KB)FinalOralCapsule0206478/2017
Tenofovir Disoproxil Fumarate (PDF - 17KB) FinalOralTablet213568/2017
Tiagabine HCl (PDF - 39KB) FinalOralTablet206468/2017
Valproic Acid (PDF - 26KB)FinalOralCapsule180818/2017
Verapamil HCl (PDF - 16KB)FinalOralTablet188178/2017


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