Teva CRL Response For Huntington’s Drug Targeted For September
Teva is on track to respond to FDA’s complete response letter for deutetrabenazine by the end of September, with a potential for approval and launch in early 2017.
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Company no longer has to worry about a US FDA advisory committee review, which the agency cancelled. Launch preparations include hiring 140 sales reps.
A second Phase III study testing the VMAT2 inhibitor in the indication was positive, positioning Teva for a neck-and-neck race to market against Neurocrine.
Keeping Track: Sandoz Erelzi Is Third Biosimilar To Clear FDA; Expanded Labels For Arzerra, Blincyto
The latest drug development news and highlights from our FDA Performance Tracker.