Alembic Pharma gets USFDA nod for antidepressant tablets

NEW DELHI: Alembic Pharmaceuticals today said it has received approval from the US health regulator for Desvenlafaxine base extended release tablets used for treating major depressive disorder and has entered into an agreement with Ranbaxy to market the product in the American market.

The company has received approval from the US Food and Drug Administration (USFDA) for Desvenlafaxine base extended release tablets, Alembic Pharmaceuticals said in a BSE filing.

The company has entered into an out-licensing agreement with Ranbaxy Pharmaceuticals Inc, a wholly-owned subsidiary of Ranbaxy for exclusively marketing the product in US, it added.

"The product will be available in 50 mg and 100 mg dosage strengths. The parties will launch the product immediately," Alembic Pharmaceuticals said.

The tablets are a bio equivalent version of Pfizer's Pristiq tablet, it added.

"The current market size for Pristiq is approximately USD 538 million," the company said.

Shares of Alembic Pharmaceuticals were today quoting at Rs 92 apiece on the BSE in later afternoon trade, up steep 14.93 per cent from their previous close.