Children's Motrin OTC switch endorsed by advisory committees for fever reduction, analgesia.
Executive Summary
CHILDREN'S MOTRIN50184 RX-TO-OTC SWITCH FOR FEVER REDUCTION, ANALGESIA recommended for approval March 28 at a joint meeting of FDA's Nonprescription Drugs and Arthritis Advisory Committees. The advisory committees endorsed Johnson & Johnson's prescription ibuprofen product, Motrin Suspension, as an over-the-counter fever reducer and analgesic. McNeil currently markets the OTC children's analgesic Children's Tylenol with acetaminophen. FDA approved the analgesic indication for prescription Motrin Suspension tablets and caplets on March 24.
You may also be interested in...
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Shire Hopes To Sow Future Deals With $50M Venture Fund
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth