Synergetics USA, Inc. has announced the signing of an addendum to its three year agreement with Codman & Shurtleff, Inc. Under the terms of the revised agreement, Codman will have the exclusive right to market and distribute a Spetzler-Malis branded disposable bipolar forceps produced by Synergetics. This arrangement supports their ongoing efforts to reduce commercial expenses associated with our neurosurgery product lines.

Shire has received approval from the FDA for INTUNIV (guanfacine) Extended Release Tablets for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents aged 6 to 17 years. The once-daily INTUNIV drug is expected to be available in the US pharmacies by November and will come in four dosage strengths (1 mg, 2 mg, 3 mg, and 4 mg).

Lundbeck Inc has received approval from the FDA for its two New Drug Applications (NDA), Sabril (vigabatrin) Tablets and Oral Solution. Lundbeck will be launching Sabril in the US during the third quarter. Sabril is indicated as a monotherapy for pediatric patients, aged between one month and two years, with infantile spasms for whom the potential benefits outweigh the potential risk of vision loss. The drug is also indicated as an add-on therapy for adult patients with refractory complex partial seizures who have failed other available treatments and for whom the potential benefits outweigh the risk of vision loss.

The Food and Drug Administration (FDA) has given the approval to Neuronetics Inc.’s Neurostar [a transcranial magnetic stimulation (TMS) device] for use in the treatment of depression. The non-invasive tool stimulates the brain by transmitting magnetic pulses to the skull. The device will help the adult patients who have not benefited from anti-depressants. Also, this therapy has no risks as associated with electric shock therapy and surgically implanted electrodes.

The 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.

Israel-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 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.