Warnings Page: Meridia, Biaxin, Accutane, Fenfluramine Updates

FDA Warning Letter States Abbott Laboratories Did Not Submit Adverse Drug Reports

A warning letter from the FDA to Abbott Laboratories states that the drug manufacturer failed to submit adverse event reports to the agency within the designated 15-day period. Some of the adverse event reports pertained to the obesity drug Meridia and the antibiotic Biaxin.

The July 19 letter states that the company failed to comply with Section 505(k)(1) of the Food, Drug and Cosmetic Act, which "requires an applicant to establish and maintain records, and report data relating to clinical experience and other data or information …