Migraine indication
This article was originally published in The Tan Sheet
Executive Summary
FDA "does not consider migraine a 'generally recognized' indication for OTC analgesic/antipyretic drug products" and the agency "has no plans to include the indication in the [analgesic] TFM in the near future," FDA tells Arnall Golden & Gregory in a Sept. 3 letter. The Atlanta-based law firm wrote the agency in May inquiring whether it intended to add migraine to the TFM, noting the firm had seen "one written statement that this amendment will occur" but was unable to receive confirmation from FDA. The firm refers to an Oct. 20, 1997 request to FDA's Labeling and Nomenclature Committee for a trademark review for Bristol-Myers' Excedrin Migraine, in which the committee notes "a tentative monograph will be written to include migraine" in the OTC statement of identity. "We strongly support this inclusion," AG&G says, adding it may file a citizen petition to that effect on behalf of an unnamed client