Glenmark Generics Receives Approval From The USFDA For Ropinirole Hydrochloride Tablets (02-Mar-2010)
Glenmark Generics Inc., USA (GGI), a subsidiary of Glenmark Generics Limited (GGL), has received ANDA approval from the United States Food and Drug Administration (U.S. FDA) for Ropinirole Hydrochloride tablets 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg , 4 mg and 5 mg and will immediately commence marketing and distribution the approved product. Ropinirole Hydrochloride tablet is the generic version of GSK''s Requip® tablet in the U.S. market.
Ropinirole hydrochloride is indicated for treatment of the signs and symptoms of idiopathic Parkinson''s disease as well as the treatment of moderate to severe primary restless leg syndrome (RLS). Total sales for Ropinirole Hydrochloride tablets in the twelve month period ending December 2009 were USD 104 million*, as reported by IMS Health.
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