PHARMACY

Leavitt suggests FDA presence in Central America

BY Alaric DeArment

NEW YORK Health and Human Services secretary Michael Leavitt has expressed interest in opening Food and Drug Administration offices in Central America similar to the ones opening in China.

Though the statement was Leavitt’s opinion and not an official announcement, he said that large imports of fruits and vegetables from Central America made such office necessary. A shipment of cantaloupes from Honduras, for example, recently caused salmonella outbreaks in 16 states.

Leavitt announced the opening of FDA offices throughout China while speaking in Beijing on May 17. The offices will help ensure the safety of products bound for the U.S. before they are exported.

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FDA approves Teva’s generic Sarafem Pulvules

BY Alaric DeArment

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.

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FDA issues approvable letter for Wyeth osteoporosis drug

BY Alaric DeArment

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.

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