USFDA guidance for petitioned ANDA [Regulatives / Guidelines]

posted by shahajan baig  – India, 2020-07-20 21:50 (20 d 15:11 ago) – Posting: # 21763
Views: 197

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


Baig Shahajan



Complete thread:

 Admin contact
20,992 posts in 4,375 threads, 1,460 registered users;
online 16 (0 registered, 16 guests [including 8 identified bots]).
Forum time: Monday 13:02 CEST (Europe/Vienna)

[Those] who have an excessive faith in their theories or in their
ideas are not only poorly disposed to make discoveries, but they
also make very poor observations.    Claude Bernard

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz