Mylan Launches Generic Version Of Glaxo's Avodart In U.S.

Mylan N.V. (NASDAQ:MYL) announced that it has launched dutasteride capsules, 0.5 mg -- the generic version of GlaxoSmithKline’s (NYSE:GSK) Avodart -- after receiving an FDA approval for an abbreviated New Drug Application (ANDA) of the drug.

Avodart is approved 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 lowering the chances of surgery need. The drug can also be used in combination with tamsulosin for the treatment of symptomatic BPH in men with an enlarged prostate.

As per IMS Health, the drug generated sales of approximately $297.2 million during the last 12 months (ended Apr 30, 2016).

We remind investors that Mylan currently has 248 ANDAs pending FDA approval, representing a total of $107.6 billion in annual brand sales, as per IMS Health. Of these, 43 are potential first-to-file opportunities which representing $37.2 billion in annual sales.

Mylan is a leading generic drug company in terms of both total and new prescriptions. The company has been making efforts to solidify its pipeline through strategic deals.

The company recently acquired the non-sterile, topicals-focused specialty and generics business of privately held Renaissance Acquisition Holdings. The deal gave Mylan access to a complementary portfolio of approximately 25 branded and generic topical products, an active pipeline of approximately 25 products, and an established U.S. sales and marketing infrastructure targeting dermatologists.

The transaction is expected to be immediately accretive to the company’s bottom-line. In Feb 2015, Mylan acquired Abbott Laboratories’ (NYSE:ABT) non-U.S. developed markets’ specialty and branded generics business.

Mylan is a Zacks Rank #3 (Hold) stock. A couple of better-ranked stocks in the health care sector are Bristol-Myers Squibb Company (NYSE:BMY) and Johnson & Johnson (NYSE:JNJ) . Both stocks carry a Zacks Rank #2 (Buy).