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FDA declines to approve Intellipharma's opioid painkiller
2017年9月25日 / 上午11点16分 / 1 个月前

FDA declines to approve Intellipharma's opioid painkiller

Sept 25(Reuters) - Intellipharmaceutics International Inc said on Monday that the U.S. Food and Drug Administration declined to approve its long-acting opioid painkiller in its current form, backing its independent advisory panel that had raised concerns over the drug’s abuse-deterrence capabilities.

The decision comes at a time when the United States is battling with the opioid abuse crisis, which claimed more than 33,000 people in 2015, according to the Centers for Disease Control and Prevention.

The FDA asked Intellipharma to complete additional studies to assess the abuse-deterrent properties of the drug when used via oral and nasal methods, the company said.

A panel of independent advisers to the FDA had voted 22-1 against approving the drug in July. (Reporting by Divya Grover in Bengaluru; Editing by Sriraj Kalluvila)

我们的标准:汤森路透“信任原则”
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