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.
"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."
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