Pharmaceutical and biotechnology major Wockhardt has received final approval from the United States Food & Drug Administration (US FDA) for marketing 5mg/ 5ml of Oxycodone HCl liquid which is used in treatment of moderate to severe acute and chronic pain. Wockhardt is launching the product soon and will be amongst the few generic versions of this product in the market.
"We are delighted to receive this ANDA approval for our Oxycodone liquid," said Dr. Habil Khorakiwala, Wockhardt Founder Chairman & Group CEO. "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," he said.
According to IMS Health, the total market for this product in the US is about $58 million. Oxycodone is used extensively in management of pain, especially in opioid tolerant patients. Wockhardt already markets several other controlled substance products in the United States and generally has a leading presence in the liquid formulations segment.
In the US generic pharmaceutical market, Wockhardt has been consistently growing market shares for all its products. In many instances, Wockhardt, by virtue of being amongst the few players to market technically challenging products has reaped the advantage of being an early entrant.
Wockhardt will be manufacturing the Oxycodone HCl liquid at its facility in Morton Grove, IL. The technology for the product was developed in-house.
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