No GRASE For Ibuprofen, No Future In OTC Internal Analgesic Monograph
Executive Summary
Nonprescription products containing ibuprofen can now only be marketed in the US through NDAs. No companies took advantage of a proposed ibuprofen addition to the the internal analgesic, antipyretic and antirheumatic OTC monograph, issued in 2002.
You may also be interested in...
OTC Naproxen Labeling: US FDA Advisory Panel Finds Imprecise Direction In PRECISION
Safety study of celecoxib vs. ibuprofen and naproxen spurs advisory committees to recommend adding aspirin-interaction warning on OTC naproxen labels, but many panelist made clear that PRECISION results had not swayed their thinking on celecoxib CV safety or on the OTC ingredients' interaction with aspirin.
OTC NSAIDs Need Additional Label Warnings – FDA Advisory Panel
Labels for over-the-counter NSAIDS need additional information about potential risks, panel members in a joint meeting of FDA’s Arthritis and Drug Safety and Risk Management advisory committees say. Data do not show naproxen has a lower CV thrombotic event risk compared to other NSAIDs, they say.
FDA Expands Acetaminophen, NSAID Labeling Beyond Tentative Final Rule
FDA's final rule for OTC products containing acetaminophen or nonsteroidal anti-inflammatory drugs requires warnings and revisions that go beyond changes the agency proposed in a 2006 tentative final rule