Drug Development

Mylan Announces Final FDA Approval for Terbinafine Hydrochloride Tablets

Published in Lab Business Week, July 22nd, 2007

Mylan Laboratories Inc. (NYSE:MYL) announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Terbinafine Hydrochloride (HCl) Tablets, 250 mg (base).

Terbinafine HCl Tablets are the generic version of Novartis' Lamisil(R) Tablets. Terbinafine HCl Tablets had U.S. sales of approximately $685 million for the 12 months ending March 31, 2007, for the same strength.

This product will be shipped immediately.

Mylan Laboratories Inc. is a leading pharmaceutical company with three principal subsidiaries, Mylan Pharmaceuticals Inc.,...

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Source: Lab Business Week (2007-07-22)

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