Drug firm Wockhardt on Wednesday said it has received the final approval from the U.S. Food and Drug Administration (FDA) for marketing Nicardipine HCI injections in 25mg/10 ml strength, used in the treatment of hypertension.
Nicardipine is the generic name for the U.S.-based drug firm EKR Therapeutics’ patented drug Cardene and the patent covering the drug expired on November 17, 2009.
Wockhardt is launching the product immediately in the U.S. market, the company said in a filing to the Bombay Stock Exchange (BSE).
“This is our 17th sterile product approval in the U.S., based on a variety of technologies like liquid injections in vials and pre-filled syringes, powder for injections and ophthalmic solutions,” Wockhardt Chairman Habil Khorakiwala said.
According to market research firm IMS, the total market for Nicardipine in the U.S. is more than $200 million.
The company would manufacture these injections at its U.S. FDA-certified formulation plant at Waluj, Aurangabad.