Alembic Pharmaceuticals receives USFDA approval for Itraconazole Capsules

16 Dec 2016 Evaluate

Alembic Pharmaceuticals has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Itraconazole Capsules, 100 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Sporanox Capsules, 100 mg of Janssen Pharmaceuticals, Inc. Itraconazole capsules had an estimated market size of $42 million for twelve months ending December 2015, according to IMS.

Itraconazole capsules are indicated for the treatment of blastomycosis, histoplasmosis and aspergillosis in immunocompromised and non-immunocompromised patients and onychomycosis in non-immunocompromised patients.

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907. The company manufactures and markets generic pharmaceuticals products all over the world. It now has a total of 52 ANDA approvals (46 Final approvals and 6 tentative approvals) from USFDA.



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