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Roxane wins FDA approval for ropinirole hydrochloride tablets

Roxane Laboratories has announced the approval of its abbreviated new drug application for ropinirole hydrochloride tablets, 0.25mg, 0.5mg, 1mg, 2mg, 3mg, 4mg, and 5mg by the FDA.

The product is available in bottles of 100 and is available for immediate shipment to wholesalers and pharmacies nationwide.

Roxane’s ropinirole hydrochloride tablets are AB rated to Requip tablets and indicated for the treatment of moderate-to-severe primary restless leg syndrome.