Content about Package insert

January 22, 2013

The Food and Drug Administration on Friday approved the distribution of 2 million additional doses of Tamiflu (oseltamivir phosphate) 75 mg that contain an older version of the package insert.

ATLANTA — The Food and Drug Administration on Friday approved the distribution of 2 million additional doses of Tamiflu (oseltamivir phosphate) 75 mg that contain an older version of the package insert.

June 28, 2011

The Obama administration recently called on the public for ideas to streamline federal regulations. In response, the National Association of Chain Drug Stores has sent its suggestion to the Food and Drug Administration.

ALEXANDRIA, Va. — The Obama administration recently called on the public for ideas to streamline federal regulations. In response, the National Association of Chain Drug Stores has sent its suggestion to the Food and Drug Administration.

February 14, 2011

GlaxoSmithKline has changed prescribing information on the labeling for one of its Type 2 diabetes drugs to reflect new restrictions on the drug’s use, the drug maker said.

PHILADELPHIA — GlaxoSmithKline has changed prescribing information on the labeling for one of its Type 2 diabetes drugs to reflect new restrictions on the drug’s use, the drug maker said.

GSK said it revised the labeling for Avandia (rosiglitazone) to take into account the risks of heart attacks and heart failure in patients taking the drug.

The FDA moved to restrict access to Avandia last year and required GSK to create a risk evaluation and mitigation strategy for the drug.

December 7, 2010

ALEXANDRIA, Va. — Simplify, simplify.


September 26, 2010

Federal efforts to simplify and standardize the information that patients receive with their prescription medications...