In Europe, information about this analysis was placed into the approved product labeling for Avandia.
Brand-name drugmakers, though, can update warnings and precautions on product labeling before obtaining FDA approval.
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Right now, there is no reason to change the product labeling for either Zetia or Vytorin, they said.
These conditions include product labeling, patient education information and a small pharmacokinetic study.
Product labeling requirements, as well as marketing, branding and retail display restrictions, are proven to reduce youth access to tobacco products and impulse tobacco purchases.
To educate prescribers about the risk of hepatotoxicity associated with the use of KYNAMRO, and the need to monitor patients during treatment with KYNAMRO as per product labeling.
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Meanwhile, though, the issue may be decided by the FDA. The agency recently disclosed plans to revise its regulations so that generic drugmakers can update product labeling and warn patients about risks associated with their drugs.
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The product labeling is available here.
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He thinks those previous trials should be barely mentioned in the product's labeling, and that the FDA should require a registry of patients on Provenge to collect more data.
When a drug is likely to cause a severe side effect--say, an increased risk of heart attack, an allergic reaction that causes the skin to burn or liver failure--the standard practice is to warn patients and doctors about the product's labeling, and to send out warning letters to physicians who might prescribe the medicine.
But Odabashian said the agency has also vetoed efforts by private companies to carry out their own testing, at their own expense, and then labeling their product as BSE-free.
The 27-nation bloc must agree on binding origin disclosures for food product ingredients, starting with a better labeling of meat products, German Agriculture Minister Ilse Aigner said.
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