(IFN) Icelandic generic pharmaceuticals company Actavis Group said Thursday its U.S. manufacturing and marketing division, Actavis U.S., has received approval from the U.S. Food & Drug Administration to market Ranitidine Oral Solution USP.
Due to Actavis first-to-file status, the FDA has granted Actavis a 180-day marketing exclusivity that will commence with the distribution of the product in the coming weeks.
Ranitidine Syrup, the generic equivalent of GlaxoSmithKlines Zantac Syrup, will be available in the 15 mg/mL strength. Ranitidine Syrup is indicated for the treatment and prevention of ulcers, gastroesophageal reflux disorder, and to treat conditions due to high acid secretion.
Annual brand sales of Ranitidine Syrup in the U.S. were approximately USD121 million for the 12 months ending December 2006, according to IMS Health data.
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Icelandic Financial News (IFN) is available on Factiva, a joint venture between Reuters and Dow Jones Newswires, FT.COM, LexisNexis, Comtex, Gale and Thomson via the Nordic Business Report.
Due to Actavis first-to-file status, the FDA has granted Actavis a 180-day marketing exclusivity that will commence with the distribution of the product in the coming weeks.
Ranitidine Syrup, the generic equivalent of GlaxoSmithKlines Zantac Syrup, will be available in the 15 mg/mL strength. Ranitidine Syrup is indicated for the treatment and prevention of ulcers, gastroesophageal reflux disorder, and to treat conditions due to high acid secretion.
Annual brand sales of Ranitidine Syrup in the U.S. were approximately USD121 million for the 12 months ending December 2006, according to IMS Health data.
(END)
Icelandic Financial News (IFN) is available on Factiva, a joint venture between Reuters and Dow Jones Newswires, FT.COM, LexisNexis, Comtex, Gale and Thomson via the Nordic Business Report.
