Alembic Pharma Gets U.S. FDA Nod To Market Generic Antidepressant Drug
The company's product is therapeutically equivalent to Otsuka Pharmaceutical Co's reference listed drug product Rexulti tablets.
Alembic Pharmaceuticals on Thursday said it has received an approval from the U.S. health regulator to market a generic antidepressant medication in the American market.
The company has received an approval from the U.S. Food & Drug Administration to market Brexpiprazole tablets in strengths of 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg, the drug firm said in a statement.
The company's product is therapeutically equivalent to Otsuka Pharmaceutical Co's reference listed drug product Rexulti tablets, it added.
Brexpiprazole tablets are indicated as an adjunctive therapy to antidepressants for the treatment of major depressive disorder and for the treatment of schizophrenia.
According to IQVIA data, Brexpiprazole tablets in strenghts of 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg have an estimated market size of USD 1.6 billion for 12 months ended Dec. 2022.
The U.S. market is the world's largest for pharmaceutical products.
In 2021-22 fiscal, India's total pharma exports to global markets, including the U.S., stood at around Rs 1,75,040 crore.
Shares of Alembic pharmaceutical were trading 0.82% down at Rs 508.10 apiece on the BSE.