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The therapeutic recommended dosages were 12.5, 25, and 50 mg with an approximate bioavailability of 93%. [12] [13] [14] Rofecoxib crossed the placenta and blood–brain barrier, [12] [13] [15] and took 1–3 hours to reach peak plasma concentration with an effective half-life (based on steady-state levels) around 17 hours.
Drugs or medicines may be withdrawn from commercial markets because of risks to patients, but also because of commercial reasons (e.g. lack of demand and relatively high production costs).
Pharmaceutical giant Merck & Co. recalled the pain relief drug Vioxx in 2004 after the FDA determined that the drug may have contributed to 27,785 heart attacks and sudden cardiac deaths between ...
Zocor, Vioxx, Pepsid: False Claims Act, Medicaid Rebate Statute 2007 Purdue Pharma [15] $601 million Off-label promotion Oxycontin: False Claims Act 2010 Allergan [16] $600 million Off-label promotion Botox: False Claims Act, FDCA 2010 AstraZeneca [17] $520 million Off-label promotion, kickbacks Seroquel: False Claims Act 2007 Bristol-Myers ...
On November 18, 2004, Dr. Graham testified before the U.S. Senate Committee on Finance about Merck's withdrawal of the popular anti-inflammatory drug Vioxx the previous month because of serious safety concerns. In his testimony, he asserted his personal belief that the policies within the U.S. Food and Drug Administration were insufficient to ...
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Product recalls are one of a number of corrective actions that can be taken for products that are deemed to be unsafe. The recall is an effort to limit ruination of the corporate image and limit liability for corporate negligence, which can cause significant legal costs. It can be difficult, if not impossible, to determine how costly can be ...
FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.