PITTSBURGH, July 2 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. today 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., Mylan Technologies Inc. and UDL Laboratories Inc., and a controlling interest in Matrix Laboratories Limited, India. Mylan develops, licenses, manufactures, markets and distributes an extensive line of generic and proprietary products.
For more information about Mylan, please visit www.mylan.com.
Mylan Laboratories Inc.
CONTACT: Patrick Fitzgerald or Kris King of Mylan Laboratories Inc.,+1-724-514-1800
Web site: http://www.mylan.com//
