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.

Barr Pharma receives FDA nod for generic Mirapex

Barr Pharmaceuticals Inc. has received FDA approval for pramipexole dihydrochloride in 0.125mg, 0.25mg, 0.5mg, 1mg and 1.5mg strengths. This drug is the generic version of Boehringer Ingelheim Pharmaceuticals Inc.’s Mirapex tablets, used for the treatment of the signs and symptoms of idiopathic Parkinson’s disease. Barr is currently challenging a patent protecting Mirapex and has agreed not to launch its generic Mirapex until 90 days following the conclusion of the presentation of evidence in the district court trial, a favorable judgment is entered by the district court or July 14, whichever comes earlier.

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.