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Pharmacy NewsMonday 8 September 2008
Actavis Receives Approval For Ranitidine Syrup In The U.S.
Actavis U.S., the United States manufacturing and marketing division of the international generic pharmaceuticals company Actavis Group (ICEX: ACT), today announced that it has received approval from the U.S. Food & Drug Administration (FDA) to market Ranitidine Oral Solution USP. Due to Actavis's 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 GlaxoSmithKline's Zantac(R) Syrup, will be available in the 15 mg/mL strength. Ranitidine Syrup is indicated for the treatment and prevention of ulcers, gastroesophageal reflux disorder (GERD), and to treat conditions due to high acid secretion.
Annual brand sales of Ranitidine Syrup in the U.S. were approximately US$121 million for the twelve months ending December 2006, according to IMS Health data.
Robert Wessman, President and CEO of Actavis, commented, "The FDA approval for Ranitidine represents one of the most significant product launches in the U.S. market. We are excited about the 180-day marketing exclusivity, and we plan to take full advantage of our unique position in the market to realize the sales potential of the product."
Doug Boothe, EVP of US Commercial and Administration, said, "The Ranitidine final approval and marketing exclusivity is a great achievement for our U.S. organization. We expect this product to be among our key products in our dynamic U.S. product portfolio, and this approval represents a visible milestone in Actavis' revitalized U.S. development efforts."
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