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Article: FDA Responds to Eon Labs' Metaxalone Biostudy.
- Article from:
- Business Wire
- Article date:
- March 24, 2003
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Business Editors
LAURELTON, N.Y.--(BUSINESS WIRE)--March 24, 2003
Eon Labs, Inc. (Nasdaq: ELAB) announced today that it received a letter from the FDA regarding its Metaxalone 400mg product, the generic alternative for Skelaxin(R)*.
In the letter, the FDA advised Eon Labs that it considers the bioequivalence study for Eon's Metaxalone under food conditions not acceptable. The request by the FDA for this food study was triggered by a citizens petition by Elan, which was filed months after Eon Labs' original application was accepted by the FDA for filing. Eon Labs addressed the inconsistencies in the process in a pending citizens petition to the ...