Archive for the 'Neurology Products' Category

FDA confirms safety and efficacy of generic Wellbutrin

Teva LogoThe FDA has concluded that Teva Pharmaceutical’s bupropion XL 300 mg, a generic version of Wellbutrin XL, is a safe and effective treatment for patients suffering from depression. Questions about the safety and efficacy of Teva’s bupropion XL arose after the agency received 85 postmarketing reports of patients experiencing side effects after switching from GlaxoSmithKline’s Wellbutrin (bupropion HCl) to the generic version.

Noninvasive treatment for depression passes test

Brainsway clinical trialsIsrael-based Brainsway Ltd. reported positive results from the final stage of testing its noninvasive Transcranial Magnetic Stimulation (TMS) treatment for depression. TMS is a noninvasive technique for applying brief magnetic pulses to the brain. The company said that it had obtained satisfactory results from its first efficacy test on 64 patients. Brainsway now intends to file for an application for CE Mark certification from the EU and subsequently aim for an FDA approval.

Medtronic receives FDA approval for RestoreULTRA

RestoreUltra from MedtronicMedtronic Inc. has received FDA approval for RestoreULTRA, an implantable neurostimulation system device for the treatment of chronic, troublesome pain in the back and leg. Patients can adjust the stimulations produced by the rechargeable device according to fluctuations in pain through a remote control, apart from directing the stimulations at a specific point in the spinal cord. The company plans to make the device available in the U.S. by the end of February.

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