Elan Miguard
Executive Summary
"Approvable" letter received for frovatriptan. FDA is requesting additional data from an ongoing preclinical study involving higher-than-previous doses in mice and supplementary data from long-term pharmaceutical stability and clinical studies of the drug. Submission of the data is anticipated by the end of the third quarter. An NDA for the anti-migraine drug was submitted in January 1999 by Vanguard Medical Group, which licensed North American rights for the product to Elan
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