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# FDA Denies Jame Fine Reconsideration Petition
- URL: https://www.fdaweb.com/fda-denies-jame-fine-reconsideration-petition/
- Published: 2016-08-02T12:00:00.000Z
- Updated: 2026-09-14T21:20:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136367

FDA has denied a 1/10/14 Jame Fine Chemicals (JFC) petition asking the agency to reconsider its decision to close a drug efficacy study implementation docket that left standing a prior determination that certain products identified in the docket were less than effective and could be introduced into interstate commerce after 1/10/14 without an approved NDA or ANDA. The petition referenced JFC manufacturing of isometheptene mucate, an active pharmaceutical ingredient in Midrin.

The denial [letter](https://www.regulations.gov/contentStreamer?documentId=FDA-1975-N-0355-0035&attachmentNumber=1&disposition=attachment&contentType=pdf&ref=fdaweb.com) says that JFC is not entitled to reconsideration because it failed to request a timely hearing in 2014 and because its request does not meet the legal requirements for reconsideration of such an agency decision.