FDA Approves Generic Version of Requip XL

Actavis Group May 18 announced that the Food and Drug Administration has approved its generic version of GlaxoSmithKline’s Requip XL (ropinirole extended-release) 2 mg, 4 mg, 6 mg, 8 mg, and 12 mg tablets.

Requip XL, which was approved by FDA in 2008, is indicated for the treatment of the signs and symptoms of idiopathic Parkinson’s disease (6 PLIR 720, 6/20/08).

Actavis said it believes this is the first generic Requip XL available in the United States. Distribution of the product has commenced, the Switzerland-based company said.