MNTA – That MYL planned to submit a Copaxone ANDA based on the product from NATCO, its Indian partner, has been known for more than a year (#msg-29902618). Thus, today’s news that MYL submitted an ANDA and the FDA decided to review it is not especially consequential for MNTA investors.
If the FDA ended up approving MYL’s Copaxone ANDA, that would of course be consequential.
Copaxone was mentioned in passing on MYL’s 4Q10 CC today.* COO Heather Bresch confirmed that the 30-month Hatch-Waxman stay on MYL’s Paragraph-IV challenge runs out in Mar 2012. We already knew this date by simple arithmetic insofar as the FDA accepted MYL’s Copaxone ANDA for review in Sep 2009 (#msg-41441618), when MYL notified Teva of the Paragraph-IV challenge triggering the start of the 30-month clock.
News 
Market Data 
Discover 
AI
