Wockhardt gets FDA approval for Nicardipine injections

Wockhardt said it has received the final approval from the US FDA for marketing Nicardipine HCI injections.

Drug firm Wockhardt on Wednesday said it has received the final approval from the US 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 US-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 US market,the company said in a filing to the Bombay Stock Exchange.

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“This is our seventeenth sterile product approval in the US based on a variety of technologies like liquid injections in vials and pre-filled syringes,powder for injection and opthalmic solutions,” Wockhardt Chairman Habil Khorakiwala said.

According to market research firm IMS,the total market for Nicardipine injection in the US is more than $200 million.

The company would manufacture these injections at its US FDA-certified formulation plant at Waluj,Aurangabad.

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