FDA Approval for Abstral (Fentanyl) Sublingual Tablets - US launch planned for Q1 2011
Uppsala, January 10, 2011 - Orexo AB (STO: ORX) announces today that its partner ProStrakan Group plc (LSE: PSK) has received approval from the US Food and Drug Administration (FDA) for Abstral®. Abstral® is licensed for the treatment of breakthrough pain in cancer patients, 18 years of age and older, who are already receiving, and are tolerant to, opioid analgesics for their underlying persistent cancer pain. “This is an important step for patients with cancer pain to have options for the treatment of their breakthrough pain,” said John Jenkins, M.D., director of FDA’s Office of New Drugs