Sanofi-Aventis to resubmit application for heart medication
BRIDGEWATER, N.J. Sanofi-Aventis plans to resubmit its application for its atrial fibrillation treatment Multaq following positive clinical data for the previously not-approvable drug.
In 2006, the Food and Drug Administration issued a not-approvable letter for Multaq, and the company said it would resubmit its application in the first part of 2008 after completion of a new trial. That trial, ATHENA, shows the drug decreased patients’ risk of cardiovascular hospitalizations or death from any cause by 24 percent, according to the company.
In the ATHENA trial, Multaq showed a 30 percent decrease in the risk of cardiovascular death on top of standard therapy, including rate control and anti-thrombotic drugs, in patients with atrial fibrillation or atrial flutter, the company said.
Multaq also significantly decreased the risk for death from arrhythmia by 45 percent, and there were fewer deaths from any cause in the Multaq group compared with placebo, according to the company. First cardiovascular hospitalization was reduced by 25 percent in the Multaq group.
FDA approves Teva’s generic Sarafem Pulvules
JERUSALEM The Food and Drug Administration has granted final to Teva Pharmaceuticals to market a drug for treating premenstrual dysphoric disorder.
The drug, fluoxetine, is a generic version of Eli Lilly’s drug Sarafem Pulvules. The FDA granted approval for Teva’s application for 10 mg and 20 mg capsules of the drug Wednesday. The FDA granted a first-to-file 180-day marketing exclusivity to Teva. The drug will ship immediately.
Teva, headquartered in Israel, is a manufacturer of generic drugs and one of the 20 largest pharmaceutical companies in the world. Teva North America operates in California, Missouri, Florida, New York, New Jersey and Pennsylvania.
FDA issues approvable letter for Wyeth osteoporosis drug
WASHINGTON Wyeth Pharmaceuticals received an approvable letter from the Food and Drug Administration for a drug to treat postmenopausal osteoporosis, the company announced Friday.
The FDA requested further analysis concerning stroke and venous thrombosis for the drug, known as bazedoxifene. The FDA made similar requests when Wyeth Pharmaceuticals filed a new drug application in December 2007. The company expects to respond to the new letter by the end of this year.
Wyeth Pharmaceuticals is a division of Wyeth, a global company specializing in pharmaceuticals, consumer healthcare products and animal healthcare products.