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news.Met Joint FDA Advisory Committee to discuss new drug application
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Purdue Pharma is working with the FDA for the development of a new version its OxyContin pain medication. It has met with the Joint FDA Advisory Committee for its new drug application (NDA) for OxyContin tablets with harder shells. The new drug with harder shells aims to make the drug abuse free.
John Stewart, president and CEO of Purdue Pharma, said: “We will continue to work with the FDA to seek approval of our NDA. We will also continue our ongoing discussions with the agency on the development and implementation of a risk evaluation and mitigation strategy as well as a carefully designed surveillance program to assess the impact of the new formulation in the market, should it be approved.”
OxyContin tablets are available by prescription from licensed professionals. The tablets were approved by FDA in 1995, for the management of moderate to severe pain as a continuous pain management medication.