Protests over FDA delay of Provenge to take place Friday
NEW YORK Opposition to a decision by the Food and Drug Administration to delay approval of a drug for prostate cancer has sparked protests, scheduled to happen nationwide on May 30.
CareToLive, an organization based in Thorofare, N.J., is sponsoring protests in eight cities in light of the FDA’s decision last May to delay approval of Provenge, an immunotherapy treatment that has been shown to extend the lives of men with late-stage prostate cancer. Seattle-based Dendreon Corporation, the drug’s creator, announced the results in 2004.
CareToLive was founded in response to the FDA’s decision, though it has denied that it is affiliated with Dendreon. Protests will occur in New York, Seattle, Chicago, Philadelphia, Cleveland, Tampa, Fla., Dearborn, Mich., and Madison, Wis.
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.