Actavis Receives Approval of Levetiracetam Oral Solution in the U.S.
MORRISTOWN, N.J., Jan. 21 -- Actavis Group, the international generic pharmaceuticals company, today announced that it has received approval from the U.S. Food & Drug Administration to market Levetiracetam Oral Solution. Distribution of the product has commenced.
Levetiracetam Oral Solution is available in the 100mg/mL strength and is the generic equivalent of Keppra(R) Oral Solution by UCB, Incorporated. Levetiracetam Oral Solution is used in the treatment of partial onset seizures in adults and children with epilepsy. Annual U.S. sales of Keppra(R) Oral Solution were US$95.9 million for the 12 months ending September 2008 according to IMS Health data.
Commenting on the new approval, Doug Boothe, CEO of Actavis in the United States said:
"The approval of Levetiracetam Oral Solution demonstrates our continuing commitment to introduce new generic products to the marketplace, as well as highlights our expertise in developing and manufacturing a wide range of dosage forms. Actavis' drive to be a leader in generic pharmaceuticals is supported by one of the largest product development pipelines in the industry. "
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 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 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.