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Mylan gets tentative US FDA approval for Lamotrigine tabs
Pittsburgh | Saturday, December 15, 2007, 08:00 Hrs  [IST]

Mylan Inc has received tentative US FDA approval for its Abbreviated New Drug Application (ANDA) lamotrigine tablets, 25 mg, 100 mg, 150 mg and 200 mg.

Lamotrigine tablets are the generic version of GlaxoSmithKline's Lamictal tablets, which had US sales of approximately $1.97 million for the 12 months ending September 30, 2007.

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.

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