Mylan launches generic Avodart Capsules

Product 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.

Mylan received final approval from the 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 US sales of approximately $297.2 million for the 12 months ending 30 April 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 31 December 2015, according to IMS Health.