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Drug firm Wockhardt has received approval from the US health regulator to market its Oxycodone HCl liquid, used for treating chronic pain, in the American market.
The company has received final approval from the US Food and Drug Administration (USFDA) to market 5mg/5ml of Oxycodone HCl liquid, Wockhardt Ltd said in a filing to the BSE.
Wockhardt is launching the product soon and will be amongst the few generic versions of this product in the market, it added.
“We have filed several abbreviated new drug applications (ANDAs) over the last couple of years from our Morton Grove Pharmaceuticals facility in Illinois, especially for liquid products. This is only the first of few others we expect soon,” Wockhardt Chairman and Group CEO Habil Khorakiwala said.
According to IMS Health data, the total market for Oxycodone HCl liquid in the US is estimated to be about $58 million.
Oxycodone is used extensively in relieving pain, especially in opioid tolerant patients. Wockhardt would be producing the drug at its Morton Grove facility in the US.
Wockhardt shares were trading at Rs 1,439 a piece on the BSE, up 2.96 per cent from the previous close.
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