Author(s):
Goli Vinitha, Mukesh Dua, Muddukrishna BS
Email(s):
krishna.mbs@manipal.edu
DOI:
10.5958/0974-360X.2019.01039.4 
Address:
Goli Vinitha1, Mukesh Dua2, Muddukrishna BS1*
1Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences (MCOPS), MAHE, Manipal, Karnataka, India.
2Associate Vice President, Regulatory affairs, Biological E Limited, Telangana, India.
*Corresponding Author
Published In:
Volume - 12,
Issue - 12,
Year - 2019
ABSTRACT:
Suitability Petition (SP) is a petition (request) to Food and Drug Administration to permit the filing of an Abbreviated New Drug Application for a drug that differs from the Reference Listed Drug. According to FDA, response timeline is 90 days. While submitting the Suitability petition to the FDA the applicant should submit in the following format: a) Action Requested, b) Statement of Grounds, c) Environmental Assessment d) Economic Impact e) Certification by applicant. A type of citizen petition submitted in compliance with 21 CFR 10.30 requesting FDA to approve or disapprove a specific change. If FDA approves a SP, the generic manufacturer can file for approval of ANDA or 505(b) 2 or 351k application for the requested change. Suitability Petition contains information of the RLD and Proposed change (Comparisons) by Generics.
Cite this article:
Goli Vinitha, Mukesh Dua, Muddukrishna BS. Current Scenario on pending Abbreviated new drug Application’s Suitability Petition. Research J. Pharm. and Tech. 2019; 12(12): 5985-5990. doi: 10.5958/0974-360X.2019.01039.4
Cite(Electronic):
Goli Vinitha, Mukesh Dua, Muddukrishna BS. Current Scenario on pending Abbreviated new drug Application’s Suitability Petition. Research J. Pharm. and Tech. 2019; 12(12): 5985-5990. doi: 10.5958/0974-360X.2019.01039.4 Available on: https://rjptonline.org/AbstractView.aspx?PID=2019-12-12-62