Alembic Pharma gains on receiving US FDA nod for Lacosamide Tablets

Alembic Pharmaceuticals advanced 3.97% to Rs 755.35 after the company announced the receipt of final approval from the US Food & Drug Administration (USFDA) for its ANDA for Lacosamide Tablets.

The approved abbreviated new drug application (ANDA) is therapeutically equivalent to the reference listed drug product (RLD) Vimpat Tablets 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 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.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world.

On a consolidated basis, the company reported a 39.7% fall in net profit to Rs 176.42 crore on a 3.2% fall in net sales to Rs 1,271.7 crore in Q3 FY22 over Q3 FY21.

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