Mylan (MYL) Unit Launches Generic Sporanox Caps
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Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. 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. This product is the generic version of Janssen Pharmaceutical Inc.'s Sporanox® and is 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(1).
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 this product immediately.
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 this product immediately.
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