The F.D.A. had approved a label, the first of its kind, that included a claim about the drug's "abuse deterrent" properties.
The Agriculture Department has approved a label for meat and liquid egg products that includes a claim about the absence of genetically engineered products.
The U.S.D.A. has approved a label for meat and liquid egg products that includes a claim about the absence of genetically engineered products.
Wyeth appealed, contending that federal drug regulators did not call for such a forceful warning and instead approved a label that simply stated a preference for a less risky method of administering the drug.
The F.D.A. approved a label saying Brilinta was more effective than Plavix in preventing deaths and heart attacks in patients with acute cardiovascular syndrome — the efficacy label AstraZeneca dreamed of, overcoming discrepancies in its pivotal trial.
As part of Tuesday's decision, the F.D.A. also said it had approved a label for the new version of OxyContin stating that it was less prone to abuse through inhaling or injecting it.
But after complaints by an animal welfare group that the labels were misleading consumers into thinking that hens were receiving indisputably humane care, the Federal Trade Commission approved a labeling change last week.
Connecticut recently became the first state to approve a provisional labeling law, though it will take effect only if four other states do the same.
SERONO SA, Geneva, a pharmaceutical company, and its marketing partner Pfizer Inc., New York, said that federal regulators had approved a new label for Serono's multiple sclerosis drug Rebif that says patients are less likely to relapse than those taking a rival drug.
Recently, the US Food and Drug Administration approved a new label for ketolides, removing specific indications (acute bacterial sinusitis and acute exacerbation of chronic bronchitis) and adding warnings and contraindications [47].
