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Mylan Sues FDA over Rights to Market Generic Celebrex

Apr 29, 2014

Mylan Inc. has filed a lawsuit against the U.S. Food and Drug Administration (FDA) over rights to exclusively market a generic version of Celebrex (celecoxib). According to Pittsburgh Business Times, the FDA would only permit exclusive 180-day market rights to the first company to file a Paragraph IV patent certification. Mylan says that this ruling has caused disarray for pharmaceutical companies’ plans. Pfizer’s patent on Celebrex expires on May 30th, and Mylan wants to be able to market their generic version of the drug then.

Celebrex is a pain medication used to treat osteoarthritis, adult rheumatoid arthritis and pain associated with menstrual cramping. It was approved by the FDA in 1999. It has been associated with several side effects, including 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.

A study published in the Journal of the American Medical Association compared a COX-2 inhibitor, Vioxx, to a traditional NSAID, and found that the risk of cardiovascular problems were twice as likely in patients who took Vioxx. Vioxx was recalled in 2004 when 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 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.

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