Purepac gabapentin approval on hold
Executive Summary
Purepac/Teva will not be able to market gabapentin capsules before December unless the companies reach an agreement with Apotex to settle a lawsuit challenging generic exclusivity rights to Pfizer's Neurontin. A federal appeals court granted Apotex' request to stay the ANDA approval of "first filer" Purepac pending resolution of Apotex' lawsuit against FDA. Purepac received approval in September 2003 but has not yet launched due to pending litigation; the company has selectively waived its 180-day exclusivity to Teva. The court's decision does not affect approvals Ivax has on tablet forms of gabapentin; Ivax says it is still considering when to launch...