Actavis Waits On Alimta Hybrid Following FDA Approval

Teva’s Actavis Obtains NDA Approval

 
• By Dean Rudge

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.

FDASignBldg21Entrance_1200x675
The FDA has approved Actavis' pemetrexed NDA but launch if off the cards for now • Source: Shutterstock

More from Products

More from Generics Bulletin