logo
Share SHARE
FONT-SIZE Plus   Neg

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."

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Federal Aviation Administration said several pilots complained about pointing of strong green laser beams at planes flying over Long Island. The location was around Farmingdale, during 9.30 pm and 10 pm. Searches are on to locate the exact source of the laser beam. The Federal official suspects that the beam came from a hand-held device. Discount retailer Big Lots, Inc. Friday reported an increase in income from continuing operations for the first quarter, from last year. The company also registered a surge in net income particularly as it had carried a loss from discontinued operations last year. Taco Bell, a division of Yum! Brands Inc, is planning to test delivery of food items on college campuses, the Street reported. The move comes at a time the fast food chain seeks to leverage demand for its popular breakfast and dinner items.
comments powered by Disqus
Follow RTT