TOTOWA, N.J., April 27 /PRNewswire/ -. Actavis U.S., the United States manufacturing and marketing division of the international generic pharmaceutical company Actavis Group (OMX: ACT), today announced that Carlsbad Technology, Inc. (CTI) has received approval of its ANDA for Zolpidem Tartrate tablets from the U.S. Food & Drug Administration. Actavis will market the product under an agreement with CTI in the United States. Distribution of the product will commence immediately.
Zolpidem Tartrate tablets, the generic equivalent of Sanofi Aventis’ Ambien(R) tablets, will be available in 5 mg and 10 mg strengths. Zolpidem Tartrate tablets are indicated for the short-term treatment of insomnia.
Annual sales of Zolpidem Tartrate tablets in the U.S. were approximately $2.2 billion for the twelve months ending December 2006 according to IMS Health data.
Terry Fullem, Senior Director of Marketing and Portfolio Management, said, “The introduction of Actavis Zolpidem tablets in the United States represents a valued addition to the expanding portfolio of products we can offer our customers.”
About Actavis
Actavis is one of the world’s leading generic pharmaceutical companies specializing in the development, manufacture and sale of generic pharmaceuticals. With headquarters in Iceland, Actavis has operations in over 30 countries, with 11,000 employees. The company’s market cap is approximately euro 3 billion ($3.8 billion) and is listed in the Iceland Stock Exchange. Actavis expects 2007 sales to total euro 1.6 billion, with approximately one- third of these sales coming from the United States, the company’s single largest market. In the U.S. 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 U.S. operations are located in New Jersey, Maryland, North Carolina, and Florida.
More information about Actavis in the United States can be found at www.actavis.us.
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
CONTACT: David Myers, Jr., Manager, Products and Communications,+1-410-277-1235, or dmyers@actavis.com, or Halldor Kristmannsson, VicePresident of Corporate Communications and IR, +1-354-535 2325, or+1-354-840 3425, or hkristmannsson@actavis.com, both of Actavis
