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In Brief: Pharmavene

Executive Summary

Pharmavene: FDA denies Pharmavene's Oct. 24 petition to file an ANDA for selegiline (Somerset's Eldepryl) 10 mg extended-release tablets. Somerset manufactures selegiline in 5 mg immediate-release tabs. In a May 8 letter to Pharmavene, FDA declares that "the proposed change in dosing interval...must be supported with trials that establish effectiveness at the new dosing interval." Somerset had responded to Pharmavene's petition on Dec. 9, arguing that Pharmavene had not shown bioequivalence to Eldepryl and that Pharmavene's studies were "incapable by design of acquiring the necessary evidence." Somerset maintains that "no petition for a controlled release generic formulation has been approved for an immediate release innovator formulation"...
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PS026278

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