Dec 5 2013
Mylan Inc. (Nasdaq: MYL) today announced that its U.S.-based subsidiary Mylan Pharmaceuticals Inc. has launched Cabergoline Tablets USP, 0.5 mg. Cabergoline Tablets USP are indicated for the treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product.
Cabergoline Tablets USP, 0.5 mg, had U.S. sales of approximately $41.67 million for the 12 months ending Sept. 30, 2013, according to IMS Health.
Currently, Mylan has 178 ANDAs pending FDA approval representing $90.3 billion in annual sales, according to IMS Health. Forty of these pending ANDAs are potential first-to-file opportunities, representing $24.1 billion in annual brand sales, for the 12 months ending June 30, 2013, according to IMS Health.