Sunday, February 3, 2008

Mylan Announces Final FDA Approval for Granisetron 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 Granisetron Hydrochloride Tablets, 1 mg (base).

Granisetron Hydrochloride Tablets are the generic version of Roche's Kytril Tablets, which had U.S. sales of approximately $89 million for the 12 months ending Sept. 30, 2007, according to IMS Health.

This product will be shipped immediately.

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