Guideline No. 6
Guidelines for Submitting NADA's for Generic Drugs Reviewed by NAS/NRC
Revised 3/19/76
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE
FOOD AND DRUG ADMINISTRATION
CENTER FOR VETERINARY MEDICINE
New animal drug applications for drugs reviewed under the NAS/NRC veterinary drug efficacy study may be submitted following publication of the report on the drug or drugs in the FEDERAL REGISTER.
NADA's for generic drugs will only be considered for those drugs reviewed by The Academy which were deemed:
a. Fully effective
b. Probably effective and which could be classed as effective based on deletion or revision of claims.
c. Probably effective for only those claims for which the drug was judged effective by NAS/NRC.
The following information must be included in the application:
1. Three copies of signed Form FDA 356V.
2. Chemistry requirements:
a. Composition of the drug including representative batch formula.
b. Supplier of the new drug substance.
c. Specification and test methods for raw materials.
d. Method of manufacture for the drug.
e. Specifications for the finished dosage form.
f. Stability data on the dosage form in the market container and a description of the analytical method used for the stability study. If only limited data are available, a commitment should be made to run post-approval studies on production batches.
If data indicate a need for an expiration date, a statement of an expiration date.
3. Certification that the firm is in compliance with Good Manufacturing Practices.
4. Bioequivalency data which compares and establishes the similarity of the generic drug to that reviewed by The Academy preferably in the target animal.
5. Tissue residue data and/or milk-out data including analytical methodology and toxicological data, when applicable.
6. Proposed draft labeling and eventually final printed labeling.
7. Drug Experience Reports if the drug has had a history of prior marketing.
This is a guideline only. It is suggested to those firms planning to submit an application, consult with a representative of CVM/NADE prior to submission of an application.
Date Issued: Oct. 20, 1971 (Editorial Revisions 3/19/76)
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