PITTSBURGH, Feb. 1 Mylan Inc. (NYSE: MYL) todayannounced that Mylan Pharmaceuticals Inc. has received final approval from theU.S. Food and Drug Administration (FDA) for its Abbreviated New DrugApplication (ANDA) for Granisetron Hydrochloride Tablets, 1 mg (base).
Granisetron Hydrochloride Tablets are the generic version of Roche'sKytril Tablets, which had U.S. sales of approximately $89 million for the 12months ending Sept. 30, 2007, according to IMS Health.
This product will be shipped immediately.
Mylan Inc. is one of the world's leading quality generic and specialtypharmaceutical companies. The Company offers one of the industry's broadestand highest quality product portfolios, a robust product pipeline and a globalcommercial footprint through operations in more than 90 countries. Through itscontrolling interest in Matrix Laboratories Limited, Mylan has direct accessto one of the largest active pharmaceutical ingredient (API) manufacturers inthe world. Dey L.P., Mylan's fully integrated specialty business, provides theCompany with innovative and diversified opportunities in the respiratory andallergy therapeutic areas.
SOURCE Mylan Inc.