USFDA guidance for petitioned ANDA [Regulatives / Guidelines]

posted by shahajan baig  – India, 2020-07-20 21:50 (799 d 00:36 ago) – Posting: # 21763
Views: 725

Under the guidance of USFDA "Determining Whether to Submit an ANDA or a 505(b)(2) Application Guidance for Industry" it is mentioned as:

"A petitioned ANDA is a type of ANDA for a drug product that differs from the RLD in its dosage form, route of administration, strength, or active ingredient (in a product with more than one active ingredient) and for which FDA has determined, in response to a petition submitted under section 505(j)(2)(C) of the FD&C Act (suitability petition), that studies are not necessary to establish the safety and effectiveness of the proposed drug product. A petitioned ANDA is generally expected to provide the same therapeutic effect as the listed drug that was relied on as the basis of the suitability petition."

I want to know that how can suitability petition can be filed without establishing the safety and effectiveness of the proposed drug.

Thanks in advance

Regards,

Baig Shahajan

Regards,

SHAHAJAN BAIG

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