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Mylan Inc.
MYL today
announced that its subsidiary Mylan Pharmaceuticals Inc. has resolved all
disputes with Teva Pharmaceuticals
TEVA stemming from litigation
brought by Mylan in federal court in the District of Columbia against the
U.S. Food and Drug Administration (FDA) concerning Mylan's abbreviated new
drug application (ANDA) for Modafinil Tablets, 100 mg and 200 mg. Modafinil
Tablets are the generic version of Cephalon's Provigil(R), indicated to
improve wakefulness in adult patients with excessive sleepiness associated
with narcolepsy, obstructive sleep apnea and shift work disorder.
Pursuant to the terms of the agreement with Teva, Mylan is permitted to
launch its Modafinil Tablets, 100 mg and 200 mg, on August 10, 2012, which
is prior to the expiration of the 180-day marketing exclusivity period
granted to Teva. Other details of the settlement are confidential, and the
agreement is subject to review by the U.S. Department of Justice and the
Federal Trade Commission.
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