Alembic Pharma gets final USFDA nod for Lacosamide Tablets USP; stock climbs 3.5%

21 Mar 2022 , 01:52 PM

Alembic Pharmaceuticals 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.

In the regulatory filing, the pharma company said that 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.

Reacting to this news, the stock is currently trading at Rs752.05 up by Rs25.55 or 3.52% from its previous closing of Rs726.50 on the BSE. The scrip opened at Rs728.30 and has touched a high and low of Rs765 and Rs728.30 respectively.

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, it added.