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news.Indian pharmaceutical firm Wockhardt has received final approval for its abbreviated new drug application (ANDA) from the US Food and Drug Administration (FDA) to market 5mg/ 5ml of Oxycodone HCl liquid to treat moderate to severe acute and chronic pain.
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Oxycodone is used in the management of pain, especially in opioid tolerant patients. The company will introduce the product soon and will be amongst the few generic versions of this drug in the market.
Wockhardt founder, chairman and group CEO Dr Habil Khorakiwala said: "We are delighted to receive this ANDA approval for our Oxycodone liquid.
"We have filed several ANDA’s over the last couple of years from our Morton Grove Pharmaceuticals facility in Illinois, USA, especially for liquid products. This is only the first of few others we expect soon."
Oxycodone HCl liquid technology was developed in-house and the company will carry out manufacturing of the product at its facility in Morton Grove, Illinois.
The company already markets several other controlled substance products in the US and generally has a leading presence in the liquid formulations segment.
In the US generic pharmaceutical market, the company has been consistently growing market shares for all its products.