Insys Therapeutics, Inc. (formerly NeoPharm, Inc.) announced the Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for Fentanyl SL Spray. The FDA will notify Insys of its PDUFA date in the 74-day letter, which is expected in the upcoming weeks.
“We are excited to have the FDA accept our filing, and we look forward to building a commercial infrastructure to launch this product for patients suffering from breakthrough cancer pain,” said Insys chief executive officer, Michael Babich. “The proprietary sublingual delivery system will provide us an opportunity to deliver pain relief to cancer patients who suffer from excruciating acute pain episodes that overcome the analgesia of chronic opioid medications.”
Release Date: May 11, 2011
Source: Insys Therapeutics, Inc.
Filed Under: Drug Discovery