FDA Approves Mylan's Granisetron Hydrochloride Tablets

Armen Hareyan's picture

Mylan Pharmaceuticals has received final approval from FDA for its Abbreviated New Drug Application 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.

Mylan Inc. is one of the world's leading quality generic and specialty pharmaceutical companies. The Company offers one of the industry's broadest and highest quality product portfolios, a robust product pipeline and a global commercial footprint through operations in more than 90 countries.

Through its controlling interest in Matrix Laboratories Limited, Mylan has direct access to one of the largest active pharmaceutical ingredient (API) manufacturers in the world. Dey L.P., Mylan's fully integrated specialty business, provides the Company with innovative and diversified opportunities in the respiratory and allergy therapeutic areas.