GlaxoSmithKline Receives Okay From FDA For Lamictal

GlaxoThe FDA has approved GlaxoSmithKline’s Lamictal XR extended-release tablets as once-a-day, add-on therapy for epilepsy in patients over 13 years of age suffering from primary generalized tonic-clonic seizures. Lamictal XR is already approved for partial onset seizures for patients in this age group.

The study depicted that the addition of Lamictal XR in therapy reduced the seizure frequency more than placebo in patients with uncontrolled primary generalized tonic-clonic seizures.

FDA reaffirms Shire exclusivity on attention-deficit-hyperactivity disorder drug

ShireThe FDA has given Shire PLC reaffirmation on a prior decision to give the attention-deficit-hyperactivity disorder drug Vyvanse five years of market exclusivity. The drug was first approved in 2007 for children between 6 and 12 years old and then again in 2008 for adults. It has competition-free sales until February 23, 2012. GlaxoSmithKline’s sales force is helping in the promotion of the drug in the US.

GlaxoSmithKline launches new treatment for Parkinson’s disease

RequipGlaxoSmithKline PLC has launched a new treatment for Parkinson’s disease (PD) in the U.K. ReQuip XL® (ropinirole prolonged-release tablets) is the U.K.’s first and only once-daily non-ergot oral dopamine agonist available for the treatment of PD1, providing continuous delivery of ropinirole from a single daily dose. Ropinirole prolonged-release is approved for the treatment of idiopathic Parkinson’s disease (Monotherapy and Adjunct Therapy) in patients already taking ropinirole immediate release tablets and in whom adequate symptomatic control has been established.

FDA delays Requip approval

GlaxoSmithKline logoThe FDA has delayed the final approval of GlaxoSmithKline Plc’s Requip XL. The drug is a once-a-day oral treatment for Parkinson’s disease, a progressive neurological disorder that slows body movement. The delay affects SkyePharma Plc, since it uses the company’s slow release technology. The FDA is expected to announce a decision on the drug’s approval in the second quarter of this year.