PITTSBURGH, Jan. 3 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. (NYSE: MYL - News) today announced that the U.S. Food and Drug Administration (FDA) has granted the company approval to market its currently approved Levothyroxine Sodium Tablets, USP as a bioequivalent and, therefore, therapeutically equivalent (i.e. AB-rated) product to Levothroid® Tablets (manufactured by Lloyd Pharmaceuticals for Forest Laboratories Inc.).
The Mylan product is currently available in 0.025 mg, 0.050 mg, 0.075 mg, 0.088 mg, 0.100 mg, 0.112 mg, 0.125 mg, 0.137 mg, 0.150 mg, 0.175 mg, 0.200 mg and 0.300 mg strengths.
Total U.S. sales for all strengths of Levothroid® Tablets, USP were approximately $32.9 million for the 12-month period ended Sept. 30, 2006, according to data from IMS Health. Levothyroxine Sodium Tablets are approved for the treatment of hypothyroidism and pituitary TSH suppression.
Robert J. Coury, Mylan's Vice Chairman and CEO commented, "Once again, Mylan continues to lead the industry through our achievement of being the first and only company to offer an AB-rated generic alternative for all four Levothyroxine brands: Synthroid®, Levoxyl®, Unithroid® and Levothroid®."
Total U.S. sales for all Levothyroxine brands and generic equivalents were approximately $1 billion for the 12-month period ended Sept. 30, 2006, according to data from IMS Health.
Mylan Laboratories Inc. is a leading pharmaceutical company with three principal subsidiaries: Mylan Pharmaceuticals Inc., Mylan Technologies Inc. and UDL Laboratories Inc. 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.
Source: Mylan Laboratories Inc.