Biotech Watch January 13-17: 4 Heavy Weight Events

Biotech Watch

IntelliPharmaceutics International (IPCIF): Aximris XR Advisory Committee Meeting


IntelliPharmaceutics International will also be sitting in on an FDA Advisory Committee Meeting of its own pretty soon, and for a pain killer of its own. However, the story here is far different.

The Advisory Committee Meeting for Aximris XR has been scheduled for January 15, 2020. The drug, also known as Oxycodone Hydrochloride extended release has a checkered past with the FDA.

In fact, on September 25, 2017, the FDA issued a CRL surrounding the drug, declining to approve it at the time. Nonetheless, the FDA accepted the response to the Complete Response Letter from the company in February of 2019.

While no new PDUFA date has been set, the Advisory Committee Meeting will likely set the stage for whether or not we can expect to see the drug approved this time around.

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