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FDA Allows Intellipharmaceutics to Skip Phase III Trials of Rexista Pain Reliever

May 22, 2015 By MedNews Leave a Comment

Toronto, Canada-based Intellipharmaceutics expects to file an NDA for its opioid painkiller Rexista XR within the next year, after receiving notification from the FDA that it won’t need to conduct Phase III clinical trials. [Read more…]

Filed Under: Drug Industry News Tagged With: Intellipharmaceutics, Pain Management, Rexista

FDA enters consent decree with Medtronic, Inc.

May 21, 2015 By MedNews Leave a Comment

The U.S. Food and Drug Administration announced today the filing of a consent decree against Medtronic, Inc., and two of the company’s officers—S. Omar Ishrak and Thomas M. Tefft —for repeatedly failing to correct violations, related to the manufacture of Synchromed II Implantable Infusion Pump Systems, medical devices that deliver medication to treat primary or metastatic cancer, chronic pain and severe spasticity. [Read more…]

Filed Under: FDA News & Alerts Tagged With: cancer, Medtronic, Pain Management, S. Omar Ishrak, Synchromed II Implantable Infusion Pump Systems, Thomas M. Tefft

FDA approves spinal cord stimulation system that treats pain without tingling sensation

May 21, 2015 By MedNews Leave a Comment

Today the U.S. Food and Drug Administration approved the Senza spinal cord stimulation (SCS) system (Senza System) as an aid in the management of chronic intractable pain of the trunk and/or limbs, including pain associated with failed back surgery syndrome, low back pain and leg pain. The Senza System can reduce pain without producing a tingling sensation called paresthesia by providing high frequency stimulation (at 10 KHz) and low stimulation amplitudes. [Read more…]

Filed Under: FDA News & Alerts Tagged With: Nevro Corp., Pain Management, Senza System

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