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Corporate - Regulatory Bodies & Rulings
Wockhardt gets nod for sale of painkiller in US

Our Bureau

Mumbai March 21 Wockhardt Ltd has announced that it has got approval from the United States Food and Drug Administrator to sell its painkiller tablets that combine Dextropropoxyphene napsylate and Acetaminophen (DPN + APAP) in the US.

The approval is Wockhardt's 16th Abbreviated New Drug Application that has got regulatory clearance in the US.

The US market for the Dextropropoxyphene combination is over $100 million and is sold under the brand name Darvocet-N, a note from the company said.

Wockhardt USA Inc, a wholly-owned subsidiary of the Mumbai-based drug company, will market the painkiller in the US.

The painkiller will be made at the US FDA-certified formulation plant at Aurangabad, Maharashtra and the active ingredient in the medicine will be manufactured at its bulk drug plant at Ankleshwar, Gujarat.

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

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