Alembic receives USFDA approval for Itraconazole capsules


Mumbai, Dec 16: Alembic Pharmaceuticals Ltd today announced that the company has received approval from US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Itraconazole capsules.

“We have received approval from USFDA for our ANDA for Itraconnazole capsules 100 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Sporanox capsules 100 mg of Janssen Pharmaceuticals Inc,” a company statement said here.

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

Itraconazole capsules had an estimated market size of USD 42 million for twelve months ending December 2015.

Alembic, one of the leaders in branded generics in the country, now has a total of 52 ANDA approvals of which 46 are final approvals and 6 tentative approvals from USFDA, it said.