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Company Launches Generic Sporanox Capsules

The product, a generic version of Janssen Pharmaceutical Inc.'s Sporanox, is indicated for the treatment of fungal infections that begin in the lungs, blastomycosis, histoplasmosis, and aspergillosis in patients who are intolerant of or refractory to treatment with amphotericin B. Itraconazole is also indicated for the treatment of fungal infections of the toenails and fingernails in non-immunocompromised patients.

Itraconazole Capsules, 100 mg, had U.S. sales of approximately $60 million for the 12 months ending March 31, 2012, according to IMS Health. Mylan is shipping the product immediately.

Itraconazole can cause congestive heart failure and should not be given to people with a history of congestive heart failure. The drug should be discontinued if signs or symptoms of congestive heart failure occur. Severe drug interactions, cardiac events, and even death can occur if itraconazole is coadministered with drugs that use the same metabolic pathway in the liver. Itraconazole has also been associated with rare cases of serious hepatotoxicity, including liver failure and death.

Visit the Mylan Web site for more information.

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