Actavis Waits On Alimta Hybrid Following FDA Approval
Teva’s Actavis Obtains NDA Approval
Executive Summary
FDA approval for a hybrid 505(b)(2) new drug application referencing Alimta has been awarded to Teva’s Actavis, with a key patent expiring in May 2022 proving a barrier to market entry. Teva was itself shot down over attempts to launch an ANDA product several years ago.
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