FDAnews
www.fdanews.com/articles/89116-fda-approves-mylan-s-generic-levothroid

FDA APPROVES MYLAN'S GENERIC LEVOTHROID

January 5, 2007

Mylan Laboratories announced that the FDA has granted the company approval to market levothyroxine sodium tablets, which are therapeutically equivalent to Forest Laboratories' Levothroid Tablets.

Levothroid is indicated for the treatment of hypothyroidism and pituitary TSH suppression. The Mylan product will be available in dosages of 0.025, 0.05, 0.075, 0.088, 0.1, 0.112, 0.125, 0.137, 0.15, 0.175, 0.2 and 0.3 mg.

Total U.S. sales for all strengths of Levothroid were approximately $32.9 million for the 12-month period ending in September 2006, according to data from IMS Health.

"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," Robert Coury, Mylan's vice chairman and CEO, said.