Teva Preps For SD-809 Tardive Dyskinesia Filing By The End Of 2016
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.
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Neurocrine secured FDA approval for the first drug to treat tardive dyskinesia, a large market that crosses multiple diseases and has blockbuster potential.
Keeping Track: Xermelo, Odactra, Noctiva Approved; Second Submissions For Avelumab And Deutetrabenazine
The latest drug development news and highlights from our US FDA Performance Tracker.
Company no longer has to worry about a US FDA advisory committee review, which the agency cancelled. Launch preparations include hiring 140 sales reps.