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Chokshi N.,Red Cross | Modi B.,Drug Information Association | Modi B.,Astron Research Pvt. Ltd
Journal of Generic Medicines | Year: 2011

Two routes are well known for fi ling the variation from the approved RLD as a generic player in the US market that is, fi ling an Abbreviated New Drug Application (ANDA) following the approval of Suitability Petition (SP) fi ling and another is fi ling New Drug Application (NDA) inline with 505(b)(2) of the act. The SP process is addressed in 21 CFR part 10.20 and 10.30, 314.54, 314.93. Most of the times it become confusing in selecting the appropriate route of fi ling and evaluating their common and uncommon requirements. Underlining information in this article helps in understating the fi ling requirement of each route and the way in which the US Food and Drug Administration (FDA) has recently begun using its authority for variations is critical for choosing the appropriate path. The differences between the SP and the 505(b)(2) NDA submission are also discussed in department. © 2011 SAGE Publications.

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