MORRISTOWN, N.J., Feb. 27 /PRNewswire/ -- Actavis Group, the international generic pharmaceuticals company, has received approval on four new products from the U.S. Food & Drug Administration.
The four products include:
Phendimetrazine tartrate tablets, 35mg: the generic equivalent of Bontril(R) tablets by Valeant Pharmaceuticals, are indicated in the adjunct management of weight loss. Annual sales of Phendimetrazine tartrate tablets had annual sales of US$3.1 million for the 12 months ending December 2007 according to IMS Health data.
Buspirone tablets, 30mg: the generic equivalent of Bristol Myers Squibb's Buspar(R). Buspirone tablets, used in the treatment of anxiety disorders, had annual sales of US$15.4 million for the 12 months ending December 2007 according to IMS Health data.
Baclofen tablets: the generic equivalent of Lioresal(R) tablets by Novartis, will be available in 10mg and 20mg strengths. Baclofen tablets are used to relax muscles and relieve pain and discomfort associated with certain nerve disorders.
Benztropine Mesylate Tablets, 0.5mg, 1mg, 2mg: are the generic equivalent to Cogentin(R). Benztropine mesylate is an antidrykinetic, which reduces the symptoms of Parkinson's disease by improving muscle control and reducing stiffness. Annual sales of Benztropine mesylate were US$12.8 million for the 12 months ending December 2007 according to IMS Health data.
Commenting on the new approvals, Terry Fullem, Vice President of Marketing and Portfolio in the U.S. said:
"These approvals signify our commitment to provide our customers with a broad and expanding pipeline. We launched 19 products in the United States in 2007 and plan to increase that number in 2008. Actavis currently has over 70 pending applications at the FDA, including a growing list of first-to-file generic products. This momentum in our development pipeline will ensure that we continue to be on the forefront of bringing new generic products to market."
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 40 countries, with 11,000 employees. The United States is the company's single largest market. Actavis' 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 http://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.
|SOURCE Actavis Group|
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