Mylan Launches Generic Version of Enlarged Prostate Drug

Mylan has launched a generic version of GlaxoSmithKline’s (dutasteride) Avodart capsules.

The 0.5 mg tablets are designed to be used as monotherapy for 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 a need for surgery related to the condition.

Avodart may also be used alongside tamsulosin for the treatment of symptomatic BPH in men with an enlarged prostate.

Mylan received approval from the FDA for its abbreviated new drug application (ANDA) on June 24, 2016. At the moment, Mylan has 248 ANDAs pending FDA approval, 43 of which are first-to-file opportunities.

For the fiscal year ending on April 30, 2016, IMS Health reported that dutasteride (0.5 mg) capsules had US sales of around $297 million.

The most common adverse reactions linked to the brand-name product are impotence, decreased libido, breast disorders, and ejaculation disorders.

Teva also launched a generic version of Avodart in October 2015.