Actavis Receives Approval of Generic Adderall XR® CII in the US
MORRISTOWN, N.J., June 25, 2012 /PRNewswire/ — Actavis Group, an international generic pharmaceuticals company, today announced that it has received approval from the US Food & Drug Administration to market Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-Release Capsules CII, (hereafter referred to as Mixed Amphetamine Salts ER Capsules), in all available strengths: 5mg, 10mg, 15mg, 20mg, 25mg, and 30mg. Distribution of the product has commenced.
Adderall XR®, and its generic equivalents, had US sales of approximately $1.99 billion for the 12 months ending March 31st, 2012, according to IMS Health.
Commenting on the new approval, Doug Boothe, CEO of Actavis in the US, said:
“The approval of Mixed Amphetamine Salts ER Capsules offers a significant value to our customers and patients. With ADHD class medications experiencing shortages in 2012, this important product will offer value and supply to the marketplace.This approval also underscores Actavis’ emphasis and commitment to bringing complex controlled-release products to the marketplace.”
Please see prescribing information at www.actavis.us/mixedamphetaminesalts.
Actavis Inc. is the U.S. subsidiary of Actavis Group hf. Approximately one third of Actavis’ sales are generated in North America, Actavis’ single largest market. Based in Morristown, NJ, Actavis has U.S. manufacturing and packaging facilities in Elizabeth, NJ; a manufacturing facility in Lincolnton, NC; and research and development facilities in Owings Mills, MD and Sunrise, FL. Please visit www.actavis.us for more information.
Adderall XR® is a registered trademark of a party other than Actavis.
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