New FDA Approvals
New FDA Approvals
FDA approves blood thinner
Lovenox (enoxaparin sodium), was recently approved as a blood-thinning agent for the prevention of life-threatening blood clots in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illnesses. Aventis Pharma in Parsippany, NJ, makes the low-molecular-weight heparin drug.
"Now, with the FDA approval of enoxaparin sodium, health care providers have an easy-to-use, convenient clinical approach to prevent blood clots that is highly effective and safe," says Alexander G. Turpie, MD, professor of medicine at McMaster University in Hamilton, Ontario, Canada, and a principal investigator of the MEDENOX (Medical patients with Enoxaparin) study, which evaluated the effectiveness of low-molecular-weight heparin on reducing the risk of venous thromboembolic events.
Full prescribing information for Lovenox is available by calling (800) 477-9626. Also, for more information, visit the Aventis web site at www.aventispharma-us.com.
Gastric ulcer proton pump OK’d
TAP Pharmaceutical Products in Lake Forest, IL, recently received FDA approval for its proton pump inhibitor Prevacid (lansoprazole), for healing and risk reduction of gastric ulcers associated with nonsteroidal anti-inflammatory drug (NSAID) use .
The FDA approval was based on three large, multicenter, double-blind clinical trials. Two studies indicate that Prevacid heals NSAID- associated gastric ulcers. The third indicates that Prevacid reduces the risk of gastric ulcers in patients with a history of gastric ulcer who require chronic use of NSAIDs.
TAP is a joint venture between Abbott Laboratories in Abbott Park, IL, and Takeda Chemical Industries in Osaka, Japan. For more information and full prescribing information, visit www.prevacid.com.
Company ends heart drug trial
SmithKline Beecham in Philadelphia recently announced it has ceased clinical investigation of lotrafibran, an experimental cardiovascular drug. Lotrafibran was in a Phase III study to evaluate its utility in preventing recurrent strokes and heart attacks. The decision to terminate the study was taken on the recommendation of an independent data and safety monitoring board, which found a lack of efficacy and raised safety concerns. For more information, visit www.sb.com.
Subscribe Now for Access
You have reached your article limit for the month. We hope you found our articles both enjoyable and insightful. For information on new subscriptions, product trials, alternative billing arrangements or group and site discounts please call 800-688-2421. We look forward to having you as a long-term member of the Relias Media community.