Catalyst

Slingshot members are tracking this event:

Tesaro (TSRO) has submitted New Drug Application (NDA) for an intravenous (IV) formulation of rolapitant to the FDA

Source Link:
http://ir.tesarobio.com/releasedetail.cfm?ReleaseID=960409

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Additional Information

Additional Relevant Details The NDA for IV rolapitant is supported by data from a clinical program that enrolled more than 400 subjects and included a bioequivalence study and several other supportive non-clinical and clinical studies. TESARO anticipates a standard 12-month review timeline for the IV rolapitant NDA.
http://ir.tesarobio....
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Catalyst Date
Occurred on:
Mar 14, 2016
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Related Keywords Nda Filing, Fda Review, Rolapitant, Intravenous Administration
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