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Mylan Laboratories Inc. (MYL) Announces Final FDA Approval for Ropinirole Hydrochloride Tablets


5/7/2008 6:48:50 AM

PITTSBURGH, May 7 /PRNewswire-FirstCall/ -- Mylan Inc. (NYSE: MYL - News) today announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Ropinirole Hydrochloride Tablets, 0.25 mg (base), 0.5 mg (base), 1 mg (base), 2 mg (base), 3 mg (base), 4 mg (base) and 5 mg (base).

Ropinirole Hydrochloride Tablets are the generic version of GlaxoSmithKline's Requip® Tablets, which had total U.S. sales of approximately $518 million for the 12 months ending Dec. 31, 2007, for the same strengths, according to IMS Health.

This product will be shipped immediately.

Mylan Inc., with a presence in more than 90 countries, ranks among the leading diversified generic and specialty pharmaceutical companies in the world. The company maintains one of the industry's broadest-and highest quality-product portfolios, supported by a robust product pipeline; owns a controlling interest in the world's second largest active pharmaceutical ingredient manufacturer; and operates a specialty business focused on respiratory and allergy therapies.

Source: Mylan Inc.

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