5 march 2013
Alembic has announced that it has received an NDA approval for extended release version of Pfizer’s anti depressant drug Pristiq. Pristiq sell approximately $550m in the US. Alembic has outlicensed rights to Ranbaxy for marketing in the US. The company will start marketing the product immediately.
Alembic will manufacture and supply the drug to Ranbaxy for marketing in the US. Vadodara-based pharma player, Alembic Pharmaceuticals Limited has received the approval from the US Food and Drug Administration (USFDA) for a bioequivalent version of Pristiq by Pfizer.
In a statement filed with the Bombay Stock Exchange (BSE) on Tuesday, Alembic informed that it has received USFDA approval for its new drug application (NDA), desvenlafaxine base extended release tablets.
The company is the sponsor and manufacturer of the NDA. Desvenlafaxine base extended release tablets is a prescription medicine and it is Alimbic’s first 505 (B) (2) filing. The product is indicated for the treatment of major depressive disorder.”The company has entered into an out-licensing arrangement with Ranbaxy Pharmaceuticals Inc, a wholly-owned subsidiary of Ranbaxy Laboratories Limited for exclusively marketing the product in the US market,” the statement said.
The product will be available in 50 mg and 100 mg disage strengths. The product will be launched immediately.
As per the industry data, the current market size for Pristiq is approximately US $ 538 million (approx. Rs 2900 crore).