Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

US FDA Granted Approval For 32 Mg EXALGO Tablets, Reveal Zalicus - Quick Facts

Zalicus Inc (ZLCVS) Monday announced that the U.S Food and Drug Administration, or the FDA, has granted its approval for the supplemental new drug application filed by Mallinckrodt Inc., a subsidiary of Covidien plc, for the 32 mg dose strength of EXALGO Extended-Release Tablets, for the management of moderate to severe pain in opioid-tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time.

The biopharmaceutical company stated that the rights to EXALGO were acquired by Mallinckrodt LLC, the pharmaceuticals business of Covidien plc, in June 2009 for $15 million in upfront payments, additional development funding of up to $16 million and a $40 million FDA approval milestone payment. Zalicus receives tiered royalties on net sales of EXALGO by Mallinckrodt.

"More than one hundred million Americans1 suffer from debilitating chronic pain that negatively impacts their quality of life; including their ability to work, attend school and care for their families," commented Mark H.N. Corrigan, MD, President and CEO of Zalicus. "By providing a variety of tablet strengths of EXALGO, physicians and patients can work together to develop and tailor a treatment regimen that optimally controls their pain."

Register
To receive FREE breaking news email alerts for Zalicus Inc. and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Beverages giant Coca-Cola Co. reported Tuesday a profit for the third quarter that decreased 14 percent from last year, despite higher worldwide volumes, reflecting a revenue drop. Adjusted earnings per share matched analysts' expectations, even as quarterly revenues missed their estimates. Following the announcement, the company's shares are trading more than five percent lower in early deals. Apple Inc. said Monday that its fourth quarter profit rose 13% from last year, driven by strong sales of its iPhones and Mac computers. The company's quarterly earnings per share also came in above analysts' expectations as did its quarterly sales. At the same time, the company gave an upbeat revenue forecast for the current quarter, which includes the all important holiday season. Programmable chipmaker Xilinx Inc. (XLNX) said Thursday after the markets closed that its second quarter profit rose 21% from last year, helped by higher revenue and better cost control. The company's quarterly earnings per share also came in above analysts' expectations as did its quarterly revenue....
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.