Mylan receives FDA approval for generic version of thyroid deficiency treatment Cytomel

Jul 16 2009

Mylan Inc. has announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Liothyronine Sodium Tablets USP, 5 mcg (base), 25 mcg (base) and 50 mcg (base).

Liothyronine Sodium Tablets are the generic version of King Pharmaceuticals' thyroid deficiency treatment Cytomel , which had total U.S. sales of approximately $54 million for the 12 months ending March 31 for the same strengths, according to IMS Health. Mylan has begun to ship this product.

Currently, Mylan has 120 ANDAs pending FDA approval representing $84.7 billion in annual brand sales, according to IMS Health. Thirty-five of these pending ANDAs are potential first-to-file opportunities, representing $16.6 billion in annual brand sales, according to IMS Health.