Alembic Pharmaceuticals receives USFDA Final Approval for Diclofenac Sodium Topical Solution USP, 2% w/w

Alembic Pharmaceuticals Limited (Alembic) has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Diclofenac Sodium Topical Solution USP, 2% w/w. The ANDA was filed by Aleor Dermaceuticals Limited (Aleor) which was amalgamated with Alembic. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pennsaid Topical Solution, 2% w/w, of Horizon Therapeutics Ireland DAC (Horizon). Diclofenac Sodium Topical Solution is indicated for the treatment of the pain of osteoarthritis of the knee(s). Refer to our label for full indication. Aleor had previously received tentative approval for this ANDA.

Diclofenac Sodium Topical Solution USP, 2% w/w has an estimated market size of US$512 million for twelve months ending Sep 2022 according to IQVIA.

Alembic has received a cumulative total of 177 ANDA approvals (154 final approvals and 23 tentative approvals) from USFDA.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 593.65 as compared to the previous close of Rs. 595.00. The total number of shares traded during the day was 5904 in over 627 trades.

The stock hit an intraday high of Rs. 606.50 and intraday low of 591.35. The net turnover during the day was Rs. 3526782.00.

Source : Equity Bulls

Keywords

AlembicPharmaceuticals INE901L01018 USFDA ANDA FinalApproval DiclofenacSodium