Mylan Inc.'s subsidiary Mylan Pharmaceuticals Inc. has received final approval from the US 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.
Itraconazole capsules, 100 mg, had US sales of approximately $60 million for the 12 months ending March 31, 2012, according to IMS Health. Mylan is shipping this product immediately.
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 Dec. 31, 2011, according to IMS Health.
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