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 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.

FDA has granted approval to the Abbreviated New Drug Application (ANDA) filed by Taro Pharmaceutical Industries Ltd. for Lamotrigine Tablets. The product is used in the treatment of seizures and the tentative FDA approval means that the tablets meet the substantive requirements for approval, but can be marketed only after the final approval has been granted.