Mylan Pharmaceuticals has won final FDA approval for its abbreviated new drug application (ANDA) of Itraconazole capsules, 100mg, the generic version of Janssen Pharmaceutical's Sporanox capsules.
The generic Sporanox 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 and also for the treatment of fungal infections of the toenails and fingernails in non-immunocompromised patients.
Mylan is shipping Itraconazole Capsules, 100mg, which had US sales of approximately $60m for the 12 months ending 31 March 2012, according to IMS Health.
At present, Mylan has 166 ANDAs pending FDA approval out of which, thirty-five are potential first-to-file opportunities, representing $25.1bn in annual brand sales, for the 12 months ending 31 December 2011, according to IMS Health.
Itraconazole can cause congestive heart failure and should not be given to people with a history of congestive heart failure and should be discontinued if signs or symptoms of congestive heart failure occur, according to Mylan.
