Healthcare Industry News:  Actavis  

Biopharmaceuticals Generics FDA

 News Release - March 1, 2007

Actavis Receives Approval for Ranitidine Syrup in the U.S.

FDA grants 180 day marketing exclusivity

REYKJAVIK, Iceland, March 1 (HSMN NewsFeed) -- 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 ZantacŪ 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."

About Actavis

Actavis is one of the world's leading generic pharmaceutical companies specializing in the development, manufacture and sale of generic pharmaceuticals. Based in Iceland, the company has operations in over 30 countries, with 11,000 employees. The company's market capitalization is approximately EUR3bn (US$3.8 billion) and is listed in the Iceland Stock Exchange. Actavis expects 2007 sales to total EUR1.6bn, with approximately one-third of these sales coming from the United States, the company's single largest market. In the US alone, the company made 38 ANDA filings in 2006 and expects to file 40-45 in the year 2007 along with 18-20 new product launches. The company's US operations are located in New Jersey, Maryland and North Carolina.

More information about Actavis can be found at http://www.actavis.com.

Information in this press release may contain forward-looking statements with respect to the financial condition, results of operations and businesses of Actavis. By their nature, forward-looking statements and forecasts involve risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. There are a number of factors that could cause actual results and developments to differ materially from that expressed or implied by these forward-looking statements. These factors include, among other things, exchange rate fluctuations, the risk that research and development will not yield new products that achieve commercial success, the impact of competition, price controls and price reductions, the risk of loss or expiration of patents or trade marks, difficulties of obtaining and maintaining governmental approvals for products, the risk of substantial product liability claims, exposure to environmental liability.


Source: Actavis

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