Alembic Pharma stock gains over 6% after USFDA approval for drug

Alembic Pharma Share Price: Pharmaceutical company Alembic Pharma's stock surged more than 6 per cent in intraday trade today (Thursday, October 3, 2024), after getting approval from the global health regulator, the U.S. Food and Drug Administration (USFDA) for a seizure drug.

On Thursday, the stock gained 6.12 from the previous close at 1:10 pm, a piece on the BSE website.

Vadodara-based multinational pharmaceutical company informed that it got the US Food & Drug Administration (USFDA) final approval for its New Drug Application (ANDA), Lamotrigine Extended-Release Tablets USP, 200 mg, 250 mg, and 300 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) Lamotrigine Extended-Release Tablets USP, 200 mg, 250 mg, and 300 mg. The company has secured a total of 216 ANDA approvals from the regulator, comprising 188 final and 28 tentative approvals.

"The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Lamictal XR Extended-Release Tablets, 200 mg, 250 mg, and 300 mg, of GlaxoSmithKline LLC (GSK)," the company said.

Lamotrigine extended-release tablets are approved for treating primary generalized tonic-clonic and partial-onset seizures in patients 13 years and older.

It will be used for adjunctive therapy or converted from a single antiepileptic drug to monotherapy.

According to IQVIA, the drug has an estimated market size of $163 million for twelve months ending June 2024.

Alembic Pharm Stock: Past performance

The stock has gained 50.73 per cent in the last one year, outperforming the Nifty 50 index. The 50-share basket has given a return of over 30 per cent in the same period.