Actavis Group, the
international generic pharmaceuticals company, announced that it has
received final approval of amlodipine besylate tablets from the U.S. Food &
Drug Administration. Distribution of the product will commence immediately.
Amlodipine besylate tablets, the generic equivalent of Pfizer's
Norvasc(R) tablets, will be available in 2.5 mg, 5 mg and 10 mg strengths
and are indicated for the treatment of hypertension, chronic stable angina
and vasospastic angina.
Annual sales of amlodipine besylate tablets in the U.S. were
approximately US$2.5 billion for the twelve months ending June 2007
according to IMS Health data.
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 39
countries, with 11,000 employees. 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 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
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 Group
actavis