Alembic Pharma stock gains more than 6% after USFDA approval of the drug
Alembic Pharma share price: The stock of the pharmaceutical company Alembic Pharma rose more than 6 percent in daily trading today (Thursday, October 3, 2024), after receiving approval from the global health regulator, the US Food and Drug Administration (USFDA) for the drug.
On Thursday, the stock gained 6.12 from the previous close at 1: 10 pm, a piece on the BSE website.
A Vadodara-based multinational pharmaceutical company announced that it has received final US Food & Drug Administration (USFDA) 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 and 300 mg. The company has received 216 ANDA approvals from the regulator, including 188 final and 28 pending approvals.
“The approved ANDA is medically equivalent to the reference listed drug product (RLD), Lamictal XR Extended-Release Tablets, 200 mg, 250 mg, and 300 mg, for GlaxoSmithKline LLC (GSK),” the company said.
Lamotrigine extended-release tablets are approved for the treatment of generalized tonic-clonic and partial-onset seizures in patients 13 years of age and older.
It will be used for adjunctive therapy or changed from one antiepileptic drug to monotherapy.
According to IQVIA, the drug has an estimated market size of $163 million for the twelve months ending June 2024.
Alembic Pharm Stock: Past performance
The stock has gained 50.73 percent in the last one year, outperforming the Nifty 50 index. A basket of 50 stocks has given a return of over 30 percent over the same period.
