FDA accepts Vernalis' Frova filing

UK-headquartered Vernalis says that the US Food and Drug Administration has accepted itssupplemental New Drug Application for Frova (frovatriptan succinate) 2.5mg tablets for the short-term (six days per month) prevention of menstrual migraine. The decision 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 for this indication, the company notes.

Under the Prescription Drug User Fee Act guidelines, the FDA is expected to complete its review within 10 months from the sNDA submission date. Vernalis' partner, Endo Pharmaceuticals, submitted the application on July 19 and the FDA has confirmed May 19, 2007, as the review completion date.