New Delhi, February 24 Alembic Pharmaceuticals announced on Tuesday that it has received approval from the US health regulator to market a generic antifungal medication.
The company has received final approval from the US Food & Drug Administration (USFDA) for Efinaconazole Topical Solution (10%).
The approved abbreviated new drug application (ANDA) is therapeutically equivalent to Bausch Health Americas, Inc.'s Jublia Topical Solution (10%).
Efinaconazole Topical Solution is indicated for the topical treatment of onychomycosis of the toenails caused by Trichophyton rubrum and Trichophyton mentagrophytes.
Alembic was one of the first ANDA applicants to submit a substantially complete ANDA with a Paragraph IV certification, the drug firm said in a statement.
According to IQVIA, Efinaconazole Topical Solution has an estimated market size of USD 500 million for the 12 months ending December 2025.
Alembic shares on Tuesday closed down 2.69% at Rs 750.15 per share on the BSE.