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which type of data need to file ANDA submission in USA ?
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Answer / navinpatel
The 1984 Hatch-Waxman Act effectively extended the
Abbreviated New Drug Application (ANDA) processes that
existed for to all generic drugs. ANDA is filed for the
approval of Generic drug in US after the expiration of DATA
Exclusivity of innovator.
ANDAs do not contain clinical studies but are required to
contain information establishing bioequivalence to the
originator.
ANDA can be filed using the Para filing as below:
Para 1 – Drug has not been patented
Para 2 - Patent has already expired
Para 3 - Date on which the patent will expire and that the
generic drug will not go on the market until that date passes
Para 4 - Patent is not infringed or is invalid
Content of ANDA in ICH CTD format:
1. Application form
2. Table of contents
3. Basis for abbreviated new drug application submission
4. Conditions of use
5. Active ingredients
6. Route of administration, dosage form, and strength
7. Bioequivalence
8. Labeling
9. Chemistry, manufacturing, and controls
10.Samples
11.Patent information
ANDA submission with Para 4 certification will get 180 days
market exclusivity.
| Is This Answer Correct ? | 5 Yes | 0 No |
Answer / darose
information on drug substance- API (DMF)+ EXCIPIENTS
INFORMATION ON FINISHED PRODUCT, MANUFACTURING AND PACKAGING
(CMC)
INFORMATION ON DEVELOPMENT (R&D)
INFORMATION ON STABILITY OF FINISHED PODUCT
LABELING
| Is This Answer Correct ? | 3 Yes | 1 No |
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