Endo Withdraws Frova sNDA For Menstrual Migraine Prevention
This article was originally published in The Pink Sheet Daily
Action comes days after former Johnson & Johnson exec Holveck takes the helm as president and CEO.
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UK company's decision to lay off almost half its workforce, divest Parkinson's therapy Apokyn and shut down U.S. operations stems from "not approvable" letter for Frova last fall for menstrual migraine.
Agency indicates potential for vascular events is another reason frovatriptan is "not approvable" for short-term prevention of menstrual migraine.
Revlimid, Copaxone, Sensipar, Enbrel, Acthar Gel and Gleevec will be the subject of a US House Committee on Oversight and Reform in an upcoming drug price hearing.