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Table of Contents
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Under the provisions of the Generic Animal Drug and Patent Term Restoration Act (GADPTRA), the sponsor of a generic animal drug product must submit an Abbreviated New Animal Drug Application (ANADA) for review and approval before the product can be legally marketed. The generic product and its uses must be the same as those of an approved animal drug, with certain exceptions, and it must be demonstrated that the generic product is bioequivalent to the approved product. This page lists the laws, forms, Policy Letters, and Guidance Documents necessary for the submission of a generic animal drug application.
A brief explanation of the process is provided in CVM Memo 50 "Information on Approval of Generic Animal Drugs"
Information on the review and approval process for a New Animal Drug Application can be found on the New Animal Drug Application Page.
Please note that many of the documents are not posted on the CVM Home Page due to their age. Paper copies are available from:
Food and Drug Administration
Center for Veterinary Medicine
Communications Staff
7519 Standish Place, HFV-12
Rockville, Maryland 20855
(240) 276-9300
Generic Animal Drug and Patent Term Restoration Act (GADPTRA)
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Public Law 100-670, Nov. 16, 1988, 102 Stat. 3971
Forms
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New Animal Drug Application - FDA Form 356V | pdf | | doc |
Policy Letters
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Describes patent and exclusivity information to be submitted to FDA by holders of approved NADAs and NADA applicants. (11/23/88)
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Describes format and content for suitability petitions, format and content for ANADAs, manufacturing requirements for ANADAs, and environmental review of generic animal drugs. (6/7/89) | pdf |
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"Exclusivity for human food safety data submitted in supplemental application"
"Withdrawal period for generic drugs"
"Substitution of an active ingredient in a combination drug or in a feed use combination"
"Labeling Requirements for Generic Drugs"
"Can a generic animal drug sponsor obtain exclusivity for an innovation approved under a supplement to an ANADA and can the pioneer drug sponsor copy the generic innovation without submitting additional data?" (8/2/89) | pdf | | doc |
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"Actions concerning ANADAs when a pioneer drug has been withdrawn from sale"
"Effect of GADPTRA on approval of pre-62 drugs under the DESI program"
"Generic feed use combination drugs" (11/2/89) | pdf | | doc |
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"Letter introducing the Revised Bioequivalence Guideline" (4/12/90)"
Revised Bioequivalence Guideline, (revised 10/09/02) |pdf| |doc|
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"Withdrawal period for generic animal drug products"
"Eligibility of a new salt or ester for a pioneer animal drug" (10/17/90)
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"Guidance for analytical methods for ANADAs"
"ANADAs, NADAs and supplemental approvals for subtherapeutic antibiotics"
"Hybrid applications"
"Waivers of In Vivo bioequivalence studies for topical products"
(3/20/91) |pdf | | doc |
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Generic copying of certain drugs that were subject to review under the Drug Efficacy Study
Implementation (DESI) program.
(7/23/91) | pdf | | doc |
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Guidance Documents
Federal Register Notices
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Docket No. 2004D-0283, CVM 200521. Guidance for Industry on Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles; Availability. Page 8596 [FR Doc. E6-02291 ] February 17, 2006 | htm | | pdf | | pre-pub |
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Docket No. 2004D-0283, CVM 200432. Draft Guidance for Industry: Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles; Availability. Pages 46553-46555 [FR Doc. 04-17627] August 3, 2004 | htm | | pdf | Comments on draft guidance due October 18, 2004
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The Draft Guidance PDF Version
The Draft Guidance Word Version
CVM Updates/FDA News
Web Page Updated by hd - April 28, 2008, 11:00 AM ET
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