Alembic Pharmaceuticals receives USFDA Final Approval for Lacosamide Tablets USP, 50 mg, 100 mg, 150 mg, and 200 mg

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) for Lacosamide Tablets USP, 50 mg, 100 mg, 150 mg, and 200 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Vimpat Tablets, 50 mg, 100 mg, 150 mg, and 200 mg, of UCB, Inc.

Lacosamide Tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older. It may not be indicated for certain other uses due to unexpired exclusivities for the RLD for such uses.

Lacosamide Tablets, 50 mg, 100 mg, 150 mg, and 200 mg, have an estimated market size of US$ 1.67 billion for twelve months ending December 2021 according to IQVIA. Alembic has received year to date (YTD) 23 approvals (16 final approvals and 7 tentative approvals) and a cumulative total of 161 ANDA approvals (139 final approvals and 22 tentative approvals) from USFDA.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 726.50 as compared to the previous close of Rs. 733.80. The total number of shares traded during the day was 7363 in over 518 trades.

The stock hit an intraday high of Rs. 740.55 and intraday low of 724.65. The net turnover during the day was Rs. 5406137.00.

Source : Equity Bulls

Keywords

AlembicPharmaceuticals INE901L01018 ANDA FinalApproval USFDA LacosamideTablets