CRANFORD, N.J., March 2 /PRNewswire/ -- Actavis U.S., the United States manufacturing and marketing division of the international generic pharmaceutical company Actavis Group (ICEX: ACT), announced that it has received approval from the U.S. Food & Drug Administration to market Hydrochlorothiazide Tablets USP, 12.5 mg. Distribution of the product will begin immediately.
Hydrochlorothiazide 12.5 mg tablets are therapeutically equivalent to the reference listed drug (RLD), Hydrochlorothiazide Tablets USP 12.5 mg, of Mylan Pharmaceuticals, Inc. The newly approved 12.5mg strength joins Actavis’ current line of Hydrochlorothiazide 25mg and 50 mg tablets. Hydrochlorothiazide is used to treat high blood pressure and fluid retention caused by various conditions, including heart disease.
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 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.
Actavis U.S.
CONTACT: Halldor Kristmannsson, VP of Corporate Communications of ActavisU.S., +354-535-2325, +354-840-3425, hkristmannsson@actavis.com
Web site: http://www.actavis.com/
