(By Balaseshan) Mylan Inc. (NASDAQ:MYL), a pharmaceutical company, said its subsidiary launched the generic version of Janssen Pharmaceutical Inc.'s anti-fungal drug Sporanox.
Mylan Laboratories Ltd. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Itraconazole Capsules, 100 mg. Mylan is shipping this product immediately.
Itraconazole capsules is the generic version of Janssen Pharmaceutical's Sporanox, which are indicated for the treatment of fungal infections that begin in the lungs, blatsomycosis, histoplasmosis, and aspergillosis in patients who are intolerant of or who are refractory to amphotericin B therapy.
Itraconazole capsules are also indicated for the treatment of fungal infections of the toenails and fingernails in non-immunocompromised patients. The capsules had U.S. sales of about $60 million for the twelve months ending March 31, 2012, according to IMS Health.
Previously in June, Mylan's subsidiary Mylan Pharmaceuticals ULC has received Health Canada approval for generic version of Actelion Pharmaceuticals Ltd.'s pulmonary arterial hypertension drug Tracleer.
On May 29, Mylan announced the launch of generic version of Pfizer Inc.'s (NYSE:PFE) top-selling cholesterol controlling drug Lipitor. Atorvastatin Calcium is indicated as an adjunct to diet in patients with primary hypercholesterolemia and mixed dyslipidemia to reduce elevated total cholesterol, LDL, triglycerides and to increase HDL cholesterol.
On May 24, Mylan announced the launch of generic version of Roche's osteoporosis treatment Bonviva in the UK and Italy. Osteoporosis is the thinning of bone tissue and loss of bone density over time, common in older women.
On May 23, Mylan said its subsidiary launched the generic version of Viramune tablets to treat patients living with HIV/AIDS, after final approval from the U.S. health regulators. This expands further the reach of Mylan's global antiretroviral portfolio.
Currently, Mylan has 166 ANDAs pending FDA approval representing $82.6 billion in annual sales, according to IMS Health. Thirty-five of these pending ANDAs are potential first-to-file opportunities, representing $25.1 billion in annual brand sales, for the 12 months ending December 31, 2011, according to IMS Health.
MYL ended Thursday's regular session at $22.75. The stock has been trading between $15.49 and $23.88 for the past 52 weeks.