Mylan Laboratories Inc announced that the US Food and Drug Administration (FDA) has granted final approval for Mylan Pharmaceuticals' Abbreviated New Drug Application for Levothyroxine Sodium Tablets in 0.025 mg, 0.050 mg, 0.075 mg, 0.088 mg, 0.1 mg, 0.112 mg, 0.125 mg, 0.15 mg, 0.175 mg, 0.2 mg and 0.3 mg strengths.
Levothyroxine Sodium Tablets are the generic version of Abbott Laboratories' Synthroid Tablets.
"We are very pleased with this product approval," stated Robert J. Coury, Mylan's vice chairman and CEO. "This approval represents a very important addition to our product portfolio and finally brings closure to some of the tactics used by others to delay legitimate generic approvals," he added.
Mylan Laboratories Inc is a pharmaceutical company having four subsidiaries, Mylan Pharmaceuticals Inc, Mylan Technologies Inc, UDL Laboratories Inc and Mylan Bertek Pharmaceuticals Inc that develop, manufacture and market an extensive line of generic and proprietary products.