February 01, 2010
The FDA has approved Lamictal XR (lamotrigine extended-release tablets, from GlaxoSmithKline) as a once daily, add-on therapy for epilepsy in patients ≥13 years of age with primary generalized tonic-clonic seizures.
January 26, 2010
FDA notified healthcare professionals of a Class I recall of Exel/Exelint Huber needles, Exel/Exelint Huber Infusion Sets, and Exel/Exelint "Securetouch+" Safety Huber Infusion Sets due to 'coring,' the cutting or dislodging of silicone cores or slivers from the ports into which they are inserted).
January 04, 2010
Valeant has announced that the FDA has accepted for review the New Drug Application (NDA) for retigabine, a neuronal potassium channel opener for the adjunctive treatment for adult epilepsy patients with partial-onset seizures.
December 03, 2009
The FDA has notified healthcare professionals and patients about the increased risk of neural tube defects and other major birth defects (eg, craniofacial defects and cardiovascular malformations) in babies exposed to valproate sodium and related products (valproic acid and divalproex sodium) during pregnancy.
September 21, 2009
Lundbeck has made available Sabril (vigabatrin) powder for oral solution and tablets for the treatment of infantile spasms and refractory complex partial seizures.