Wockhardt gets FDA nod to market painkillers in US

Wockhardt Ltd said on Tuesday it has got US Food and Drug Administration's approval to market painkiller tablets containing a combination of Dextropropoxyphene napsylate and Acetaminophen in the US market.

"Wockhardt is the world's largest manufacturer of Dextropropoxyphene and our products based on this drug are sold all over the world. This is our 16th ANDA approval and our first painkiller to be sold in the US," company Chairman Habil Khorakiwala said.

Dextropropoxyphene combinations are one of the more potent analgesic drugs and is widely used all over the world for control of various kinds of pain, the company said it a filing to the Bombay Stock Exchange.

The US market for the Dextropropoxyphene combination is over $100 million and is sold under the brand name 'Darvocet-N'. Wockhardt USA Inc, the company's wholly-owned subsidiary, would be marketing the painkiller in the US.

The DPN+APAP tablets are manufactured at the US FDA-certified formulation plant at Aurangabad in Maharashtra and the active ingredient is manufactured at USFDA-approved bulk drug plant at Ankleshwar in Gujarat.

The company currently markets 15 products in the US, 10 of which were launched during 2006.