Mylan Launches Generic Provigil, Lithium Carbonate

Mylan is launching a generic version of sleep disorder drug Provigil after receiving FDA approval of the follow-on treatment and resolving its tumultuous first-filer fight with Teva. The FDA approval follows approvals by the U.S. Department of Justice and FTC of Mylan and Teva’s June settlement agreement. The settlement stems from a lawsuit Mylan filed earlier this year against the FDA over its decision to grant Teva sole first-filer status for generic Provigil (modafinil). Mylan alleged the agency overlooked an anti-competitive legal loophole in making its decision. That suit has been settled and dismissed, Mylan spokeswoman Nina Devlin told Generic Line.
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