PHARMACY

FDA alerts consumers over concerns regarding Cephalon’s Fentora

BY Drew Buono

WASHINGTON The Food and Drug Administration is alerting consumers and health care professionals over concerns of the use of the drug Fentora after reports of deaths and other adverse events.

The deaths reported were the result of improper selection of patients, dosing, or improper product substitutions. The FDA, through its Public Health Advisory and Health Care Professional Sheet warned physicians and other health care professionals that it is vital to follow product labeling when administering Fentora. The FDA also warned about the dangers of using the drug for short-term pain like headaches and migraines, and that is was also important that Fentora not be used in patients who are not opioid tolerant.

“FDA is monitoring this issue very closely,” said Steven Galson, director of FDA’s Center for Drug Evaluation and Research. “We are working with the manufacturer [Cephalon] to ensure the safest use of this medicine. Health care professionals and patients need to be aware of the potential for fatal overdose with the improper use of Fentora.”

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A new clinical data recently showed that patients with uncontrolled Type 2 diabetes treated with metformin were four times more likely to achieve recommended blood sugar control levels by adding Galvus to their treatment compared to those who took a place

BY Drew Buono

BASEL, Switzerland New clinical data recently showed that patients with uncontrolled Type 2 diabetes treated with metformin were four times more likely to achieve recommended blood sugar control levels by adding Galvus to their treatment compared to those who took a placebo, according to Novartis.

Galvus was approved last year by the Food and Drug Administration. The drug is a member of a new class of diabetes medicines called DPP-4 inhibitors, which also includes the drug Januvia, made by Merck.

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FDA bill currently in consideration to regulate prescription drug advertising

BY Drew Buono

WASHINGTON A new user fee program for Direct-To-Consumer broadcast ads will soon be put into law as part of a Food and Drug Administration bill working its way through Congress.

As a result, sponsors will soon have to tell the FDA how many of these ads it expects to submit for pre-view during the fiscal year 2008. Otherwise, you can be charged 50 percent for late penalty fees or lose your payment if you underestimate the number of ads you’ll run.

The FDA will be given power to determine what is acceptable and what is not, so it will be the job of the sponsors to conform to the FDA’s requirements to avoid those extra fees. The ads could be priced anywhere from $62,500 to $83,000, depending on how much money the FDA will need to keep the program going.

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