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Those could include "changes to the labeling and indications for existing products or a new product that might deliver nicotine at different rates, or through different delivery mechanisms," the post said.
After a few further changes to the labeling not related to intra-arterial injection, the FDA approved Wyeth's 1981 application in 1998, instructing that Phenergan's final printed label "must be identical" to the approved package insert.
As part of the settlement, the company created a $35 million fund to reimburse consumers and agreed to make changes to the labeling and marketing of Activia and DanActive products.
WASHINGTON — The Food and Drug Administration on Tuesday announced changes to the labeling requirements for long-acting painkillers, in a further effort to curb prescription drug abuse, which has been on the rise in recent years.
The devices, which deliver an electric shock as a presumed deterrent to these behaviors, "present an unreasonable and substantial risk to public health that cannot be corrected or eliminated through changes to the labeling," according to a news release from the agency.
On 7 April 2005, the FDA requested that valdecoxib be removed from the market and recommended a series of changes to the labeling for COX-2 inhibitors and NSAIDs.
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Eric Ende, a biotechnology analyst at Merrill Lynch, called the meeting "benign," saying he did not expect any changes to the labels of the drugs until more data was obtained.
Joseph P. Riccardo, a sell-side analyst at Bear Stearns, thinks Prempro sales have already bottomed out, and that the changes to the label won't further hurt sales.
Last year, the EPA tested multiple Hyundai and Kia models that had become the focus of consumer complaints about fuel-economy ratings, and ordered changes to the labels.
Key changes to the original labels include the use of a non-branded logo, high-contrast color bands for dosage strength, and an enhanced three-dimensional tablet image.
However, soon after alendronate release, an unexpected higher number of cases of oesophagitis and oesophageal strictures were encountered when the drug was prescribed to the general population, which resulted in changes to the alendronate label [ 22, 23].
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