How suitable are the suitability petition and 505(b)(2)?

Abstract

Two routes are well known for filing the variation from the approved RLD as a generic player in the US market that is, filing an Abbreviated New Drug Application (ANDA) following the approval of Suitability Petition (SP) filing and another is filing 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 filing and evaluating their common and uncommon requirements. Underlining information in this article helps in understating the filing 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.

Keywords

suitability petition 505(b)(2)ANDA NDA filing procedure

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References

1.21 CFR part 10.20 and 10.30, 314.54, 314.93, http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm.

2.Ken's Kennel ‘ANDA Suitability Petition Vs 505 (b)(2)’, Published 12 June 2009, http://www.camargoblog.com/2009/06/12/anda-suitability-petition-vs-505b2/.

3.US FDA Petition Docket No. 86P-0386/CP.

4.US FDA Petition Docket No. 86P-0386/CP and Petition 92P-0224/CP.

5.US FDA Petition Docket No. 85P-0025/CP.

6.US FDA Petition Docket No. 85P-0075/CP.

7.US FDA Petition Docket No. 85P-0492/CP.

8.21 CFR part 314.55(a).

9.63 Fed. Reg. at 66641 (FDA response to Comment 10).

10.

10.Regulatory Affairs Journal (RAJ) Pharma February 2010, 75–78.

11.

11.Withdrawal of Approval of 128 SPs, Federal Register, 23 February 2007, 72(36), 8184–8189 & Withdrawal of Approval of 128 SPs; Corrections, Federeal Register, 7 October 2008, 73(195), 58606, http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-23721.pdf.