Alembic Pharmaceuticals Limited (Alembic) today announced that its joint venture Aleor Dermaceuticals Limited (Aleor) has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Efinaconazole Topical Solution, 10%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Jublia Topical Solution, 10%, of Bausch Health Americas, Inc. (Bausch). Efinaconazole Topical Solution, 10% is indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.
Efinaconazole Topical Solution, 10% has an estimated market size of US$ 233 million for twelve months ending December 2020 according to IQVIA. Aleor has settled the case with Bausch Health and. will launch its generic as per the terms of settlement.
Alembic has a cumulative total of 140 ANDA approvals (123 final approvals and 17 tentative approvals) from USFDA.
Shares of ALEMBIC PHARMACEUTICALS LTD. was last trading in BSE at Rs.975.85 as compared to the previous close of Rs. 972.55. The total number of shares traded during the day was 6494 in over 551 trades.
The stock hit an intraday high of Rs. 986.1 and intraday low of 970. The net turnover during the day was Rs. 6349774.