Genentech, Inc. has submitted an application to the U.S. Food and Drug Administration  for its product Avastin® as a therapy for patients of glioblastoma who have received a treatment previously. If the supplemental Biologics License Application (sBLA) is accepted by the FDA, the drug can be considered for a provisional approval for treatment of cancer and other such deadly diseases. Glioblastoma is the most aggressive form of brain cancer. It has no cure. The study found that Avastin, when as evaluated as a single agent, showed that 43 percent of patients experienced no progression of disease.

The U.S. Food and Drug Administration has given the approval to UCB’s Vimpat® (lacosamide) for use as an adjunct therapy in the treatment of partial-onset seizures in epilepsy patients older than 17 years of age. The novel anti-epileptic drug has an innovative mechanism of action which involves the modulation of activity of sodium channels in the nervous system. It prolongs the long-lasting resting condition of the channel, thereby controlling the hyperactive nerve cells.

The U.S. Food and Drug Administration has cleared US Spine’s Preference 2 Complex Spine System™ for use in the United States. With this approval, US Spine makes an entry into the deformity and trauma market. Designed by some of the leading spine surgeons for the treatment of complex spinal conditions, the system is featured by a number of new components that include hooks, screws and rods. The anchoring implants in the system are featured by Helical Flange® Closure mechanism that reduces cross threading drastically and eliminates head splay.

The U.S. Food and Drug Administration has approved AstraZeneca’s once-daily Extended-Release Tablets, SEROQUEL XR (quetiapine fumarate) for the acute treatment of episodes of depression and mania related to bipolar disorder. In the long term, patients suffering from this disease may experience depressive symptoms as long as three times to that of manic symptoms. It must be noted that this is the first such medication approved buy the regulatory authority for treating the serious psychiatric illness.

The U.S. Food and Drug Administration has cleared Neuronetics, Inc.’s NeuroStar Transcranial Magnetic Stimulation (TMS) system for treating Major Depressive Disorder in adults whose condition did not improve by the intake of minimally effective dose of an antidepressant. A non-systemic and non-invasive solution for depression, the NeuroStar TMS device delivers magnetic pulses to stimulate nerve cells of that area of the brain which is associated with depression. Patients do not need to be anesthetized and the whole outpatient procedure is over in 40 minutes.

The U.S. Food and Drug Administration has granted 510(k) clearance to NeuroMetrix, Inc.’s UNIVERSAL Electrodes. NeuroMetrix can, now, launch the electrodes which are to be used in conjunction with the company’s ADVANCE(TM) NCS/EMG System to perform studies in nerve conduction. The UNIVERSAL Electrodes are for single patient use and are disposable. These electrodes will allow doctors to stimulate and record from any peripheral nerve at both proximal and distal sites.

The U.S. Food and Drug Administration has approved Life Recovery Systems‘ ThermoSuit(R) System, a rapid patient cooling device for use in a clinical study of patients suffering from traumatic brain injury. Till now, the system has been in use to induce rapid cooling of heart patients only.The study which will be conducted at the University of Texas Health Science Center in Houston will investigate whether the induction of hypothermia will result in higher number of patients coming up with good outcomes at six months and 12 months after injury as compared to patients who were randomized to normothermia.

The FDA has approved the first generic versions of Requip (ropinirole hydrochloride) tablets for the treatment of moderate to severe Restless Legs Syndrome. Requip tablets have been approved in the 0.25 milligram, 0.5 milligram, 1 milligram, 2 milligram, 3 milligram, and 4 milligram dosages. Roxane Laboratories Inc., Teva Pharmaceuticals USA, Par Pharmaceuticals Inc., and Mylan Pharmaceuticals Inc. have received approval to market the ropinirole hydrochloride tablets.

The FDA has granted approval for the Abbreviated New Drug Application (ANDA) filed by Sun Pharmaceutical Industries Ltd. to market the generic Cerebyx®, fosphenytoin sodium injection. The drug is used in generalized convulsive status epilepticus and for the prevention and treatment of seizures when neurosurgery is being performed. The fosphenytoin sodium injection is available in 100 mg Phenytoin sodium equivalents/2 mL and 500 mg Phenytoin sodium equivalents/10 mL single dose vials.

  Pozen Inc. and GlaxoSmithKline Inc. have received the FDA approval for their Treximet drug, a combination of naproxen sodium and sumatriptan, for the treatment of migraine. The drug is a follow-up to GlaxoSmithKline’s blockbuster migraine drug, Imitrex. GlaxoSmithKline said that clinical trials of Treximet indicate that the drug provided migraine relief at two hours for a significantly greater percentage of patients than Imitrex 85 mg or naproxen sodium 500 mg alone.