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.
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.
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.
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].
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.
Therefore, this study aims to address two topics: (1) to evaluate the outcomes of PSUR evaluations and identify determinants for PSURs that lead to regulatory actions, defined as safety-related changes, to the product labeling; (2) to assess the outcomes of safety-related follow-up requirements that resulted from PSUR assessment.
Aricept remains safe, Ms. Shuler said, and the company is not recommending any changes to the drug's label.
The Food and Drug Administration is considering changes to the Nutrition Facts label to help consumers make more healthful choices.
WASHINGTON -- First lady Michelle Obama announced sweeping changes to the "Nutrition Facts" label on most packaged foods on Thursday, marking a major victory against some of the most powerful lobbies in Washington: the sugar farming and refining and processed food industries.
