Mylan Inc. (Nasdaq: MYL) today announced that its U.S.-based subsidiary Mylan Pharmaceuticals Inc. has launched Repaglinide Tablets, 0.5 mg, 1 mg and 2 mg. This product is the generic version of Novo Nordisk's Prandin®, which is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The company received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product.
Repaglinide Tablets, 0.5 mg, 1 mg and 2 mg, had U.S. sales of approximately $212.95 million for the 12 months ending Sept. 30, 2013, according to IMS Health.
Currently, Mylan has 187 ANDAs pending FDA approval representing $93.7 billion in annual sales, according to IMS Health. Forty-one 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. When including ANDAs associated with Mylan's recent acquisition of Agila, the company now has a total of 287 ANDAs pending FDA approval.