Mylan launches generic Avodart capsules

HERTFORDSHIRE, England and PITTSBURGH -- Mylan announced Monday that it has launched Dutasteride Capsules, 0.5 mg, the generic version of GlaxoSmithKline's Avodart Capsules, in the U.S.

Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated as monotherapy for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms, reduce the risk of acute urinary retention and reduce the risk of the need for BPH-related surgery. It may also be used with tamsulosin for the treatment of symptomatic BPH in men with an enlarged prostate.

Dutasteride Capsules, 0.5 mg, had U.S. sales of approximately $297.2 million for the 12 months ending April 30, 2016, according to IMS Health.

Currently, Mylan has 248 ANDAs pending FDA approval representing $107.6 billion in annual brand sales, according to IMS Health. Forty-three of these pending ANDAs are potential first-to-file opportunities, representing $37.2 billion in annual brand sales, for the 12 months ending December 31, 2015, according to IMS Health.