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FDA accepts Insys Fentanyl SL Spray NDA

Insys Therapeutics, a developer of pharmaceutical products, has received the US Food and Drug Administration's (FDA) acceptance for Fentanyl SL Spray new drug application (NDA).

Insys uses proprietary technologies for the development of product candidates that address the clinical shortcomings of existing commercial products.

Insys CEO Michael Babich said they are excited to have the FDA accept their filing, and they look forward to building a commercial infrastructure to launch this product for patients suffering from breakthrough cancer pain.

"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," Babich said.