Aleor Dermaceuticals Limited receives USFDA Final Approval for Diclofenac Sodium Topical Gel, 3%

Alembic Pharmaceuticals Limited (Alembic) today announced that its wholly owned subsidiary, Aleor Dermaceuticals Limited (Aleor) has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Diclofenac Sodium Topical Gel, 3%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Solaraze Topical Gel, 3%, of fougera Pharmaceuticals Inc. (Fougera). Diclofenac Sodium Topical Gel, 3% is indicated for the topical treatment of actinic keratoses. Sun avoidance is indicated during therapy.

Diclofenac Sodium Topical Gel, 3% has an estimated market size of. US$10 million for twelve months ending Mar., 2022 according to IQVIA.

Alembic has received a cumulative total of 169 ANDA approvals (145 final approvals and 24 tentative approvals) from USFDA.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 701.15 as compared to the previous close of Rs. 700.05. The total number of shares traded during the day was 8056 in over 1379 trades.

The stock hit an intraday high of Rs. 705.45 and intraday low of 691.05. The net turnover during the day was Rs. 5633402.00.

Source : Equity Bulls

Keywords

AlembicPharmaceuticals INE901L01018 AleorDermaceuticals FinalApproval USFDA ANDA DiclofenacSodiumTopicalGel