Mylan Laboratories Inc. announced that the US Food and Drug Administration (FDA) has granted 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, a company press release said.
Total US sales for all strengths of Levothroid tablets, USP were approximately $32.9 million for the 12-month period ended September. 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 US sales for all Levothyroxine brands and generic equivalents were approximately $1 billion for the 12-month period ended September. 30, 2006, according to data from IMS Health.