Mylan Unveils Generic Avodart Capsules

Mylan N.V. MYL revealed Friday the launch of Dutasteride Capsules, 0.5 mg, the generic version of GlaxoSmithKline's Avodart Capsules in the United States. The company got the ultimate approval from the Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for this product. That is indicated as monotherapy for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms, reducing the risk of acute urinary retention and the risk of the need for BPH-related surgery.

Mylan indicated it might also be used with tamsulosin for the treatment of symptomatic BPH in men with an enlarged prostate. The company added that Dutasteride Capsules, 0.5 mg, had sales of about $297.2 million in the United States for the 12 months ending April 30, 2016.

The company quoted IMS Health and said it has 248 ANDAs pending FDA approval representing $107.6 billion in annual brand sales. The company added that forty-three of these pending ANDAs have the potential first-to-file opportunities, representing $37.2 billion in annual brand sales, for the 12 months ending December 31, 2015.

Shares of the company traded 5.94 percent down on Friday.