Barr Would Share Generic Provigil Exclusivity Under FDA’s Revised Guidelines
Barr would share exclusivity for its generic version of Cephalon's narcolepsy agent Provigil (modafinil) with three other generic companies under FDA's new guidance redefining "first-to-file" status
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FDA's guidance defining "first-to-file" status for generic drug companies launching patent challenges offers some relief for ANDA applicants jockeying for position at the agency - and may offer a further impetus for changes to the current 180-day exclusivity system
Cephalon's Provigil (modafinil) sNDA to improve wakefulness in patients with excessive sleepiness associated with disorders of sleep and wakefulness will be reviewed by FDA's Peripheral & Central Nervous System Drugs Advisory Committee on Sept. 25. Cephalon filed the sNDA for the new indication Dec. 20, 2002; Provigil is currently approved for sleepiness associated with narcolepsy. The meeting will be held at the Holiday Inn in Bethesda, Md. beginning at 8 a.m. [To 1watch a webcast of this meeting, visit FDAAdvisoryCommittee.com]...