Alembic Pharmaceuticals Limited receives USFDA Final Approval for Dapsone Gel, 5%

Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Dapsone Gel, 5%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Aczone Gel, 5%, of Almirall, LLC. Dapsone Gel is indicated for the topical treatment of acne vulgaris. Refer label for a detailed indication.

Alembic has a cumulative total of 244 ANDA approvals (224 final approvals and 20 tentative approvals) from USFDA.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 771.50 as compared to the previous close of Rs. 780.65. The total number of shares traded during the day was 4702 in over 397 trades.

The stock hit an intraday high of Rs. 781.90 and intraday low of 768.00. The net turnover during the day was Rs. 3639912.00.

Source : Equity Bulls

Keywords

AlembicPharmaceuticals INE901L01018 USFDA FinalApproval ANDA DapsoneGel