Mylan Inc. is suing the U.S. Food and Drug Administration (FDA) over a ruling about rights to exclusively market a generic version of Celebrex (celecoxib). Pittsburgh Business Times reports that, according to Myland, the FDA would only permit exclusive 180-day market rights to the first company to file a Paragraph IV patent certification. Mylan alleges in its lawsuit that this ruling has caused disarray for pharmaceutical companies’ plans, including their own. The company wants to be able to market their generic version of Celebrex on May 30th, when Pfizer’s patent expires.
Celebrex is a pain medication that was approved by 1999. It is often used to treat conditions such as osteoarthritis, adult rheumatoid arthritis and pain associated with menstrual cramping. Side effects associated with Celebrex include heart attack, blood clots and strokes. Celebrex is part of a class of drugs known as COX-2 inhibitors, which have been linked to a higher risk of stroke and heart attack. One top researcher at the University of Pennsylvania told a US regulatory panel that the body reacts the same way to all drugs in this class, and that COX-2 inhibitors create an imbalance in the body’s cardiovascular system. In the past, the Journal of the American Medical Association published a study comparing a COX-2 inhibitor, Vioxx, to a traditional NSAID. The study found that the risk of cardiovascular problems were twice as likely in patients who took Vioxx. In 2004, Vioxx was recalled after a study found that it doubled the risk of heart attack and stroke after 18 months.
In March 2006, a group of New Zealand researchers reevaluated previous studies and found that Celebrex can increase the risk of a heart attacks. The analysis involved data from six studies and 12,780 patients. The results were published in the Journal of the Royal Society of Medicine.