Insys Therapeutics, Inc. (formerly NeoPharm, Inc.) (Other OTC:NEOL.PK) today announced that the Food and Drug Administration (FDA) has 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”
"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 CEO 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."
Aspirin shows no benefit in preventing breast cancer recurrence, study finds