Wednesday, May 7, 2008

Mylan Announces Final FDA Approval for Ropinirole Hydrochloride Tablets

Mylan Inc. 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(R) 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.

(Source:http://www.pharmalive.com/News/index.cfm?articleid=537991&categoryid=24)

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