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Article: Vernalis plc Announces FDA Acceptance for Filing of Frova(R) for Short-Term Prevention of Menstrual Migraine.
- Article from:
- PR Newswire
- Article date:
- September 20, 2006
CopyrightCOPYRIGHT 2006 PR Newswire Association LLC. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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WINNERSH, England, Sept. 20 /PRNewswire-FirstCall/ -- Vernalis plc today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the supplemental New Drug Application (sNDA) for Frova(R) (frovatriptan succinate) 2.5 mg tablets for the short-term (six days per month) prevention of menstrual migraine (MM). Acceptance for filing indicates recognition by the FDA that the submission is complete and warrants full review of the data needed to assess the safety and efficacy of Frova(R) for the short-term prevention of MM.
Under the Prescription Drug User Fee Act (PDUFA) guidelines, the FDA is expected to complete its review within ten months ...