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Table of Contents
GADPTRA - Public Law
Forms
Policy Letters
Guidance Documents
Federal Register Notices
CVM Updates
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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
(301) 827-3800
Generic Animal Drug and
Patent Term Restoration Act (GADPTRA)
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Public Law 100-670, Nov. 16, 1988, 102 Stat. 3971
Forms
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
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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
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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)
| pdf | | doc
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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 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 [TXT] [PDF] Comments on draft guidance due October 18, 2004
The Draft Guidance PDF Version
The Draft Guidance Word Version
CVM Updates
Updated Tuesday, August 3, 2004 @ 7:15 PM by swd
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