Wyeth withdraws pain product application from EMA review
This article was originally published in The Tan Sheet
Executive SummaryWyeth Consumer Healthcare withdraws its centralized marketing authorization application for ibuprofen/diphenhydramine hydrochloride 200 mg/ 25 mg soft capsules, the European Medicines Agency announces Jan. 15. The agency says Wyeth withdrew the application because the Committee for Medicinal Products for Human Use concluded the data submitted does not support a positive benefit-risk balance for the analgesic and sedating antihistamine combination to be used by adults whose pain keeps them awake. Wyeth applied for marketing authority for the product Dec. 4, 2008, and withdrew it while under review by CHMP
You may also be interested in...
Abbott is encouraged by results from two studies of its Proclaim XR neurostimulation system for chronic pain, presented at the annual North American Neuromodulation Society (NANS) meeting in Las Vegas. See what Steven Falowski of Neurosurgical Associates of Lancester in Pennsylvania said about it here.
While disappointing result will probably put an end to single-drug plans in ovarian cancer, the blockbuster anti-PD-1 immunotherapy remains in combination development for the indication.
According to the plaintiff, Unilever’s Pond’s Rejuveness Anti-Wrinkle Cream is defective insofar as tested product has been found to contain unlabeled mercury, constituting negligence that has resulted in user injuries. The plaintiff seeks certification of a transnational class and compensatory and punitive damages, among other relief.