Ibuprofen Detailed Renal, GI Warnings Required For Monograph Inclusion
This article was originally published in The Tan Sheet
Executive Summary
Clinical study data and adverse event reports support inclusion of a warning on OTC ibuprofen labeling to alert consumers at risk for developing acute renal failure to consult a doctor, FDA says
You may also be interested in...
McNeil Supports Separate Alcohol, Stomach Bleeding Warnings For Ibuprofen
McNeil Consumer & Specialty Pharmaceuticals endorses separate warnings for alcohol-related stomach bleeding and general gastrointestinal bleeding for 200 mg ibuprofen because the statements would target separate populations, the firm states in Sept. 2 comments to FDA
Ibuprofen ANDA Status Backed By Dr. Reddy’s; Foreign-Sources Defended
Dr. Reddy's Labs claims "there is no need whatsoever" to include ibuprofen 200 mg in the Internal Analgesic, Antipyretic & Anti-rheumatic Drug Products Tentative Final Monograph, in recent comments to FDA
McNeil Supports Separate Alcohol, Stomach Bleeding Warnings For Ibuprofen
McNeil Consumer & Specialty Pharmaceuticals endorses separate warnings for alcohol-related stomach bleeding and general gastrointestinal bleeding for 200 mg ibuprofen because the statements would target separate populations, the firm states in Sept. 2 comments to FDA