FDA Gives 7 Companies Go Ahead To Market Generic Plavix

FDA Gives 7 Companies Go Ahead To Market Generic PlavixThe U.S. Food & Drug Administration (FDA) just gave seven companies the go-ahead to market generic Plavix.

Plavix is a blood thinner prescribed for the prevention of blood clots, heart attacks, and which has been linked to serious side effects such as the heart attacks and strokes it is supposed to prevent, as well as gastrointestinal bleeding, bleeding ulcers, cerebral bleeding, thrombotic thrombocytopenic purpura (TTP), and other problems.

According to CBS/AP the Plavix patent just expired, which will give patients a number of lower cost options now that the FDA is permitting seven companies to sell generic Plavix—clopidogrel–in the standard 75-milligram dose. Four other generic drug makers have also received approval to sell the medication in a 300-milligram dose, which is typically used in the treatment of patients who have suffered a heart attack.

Brand name Plavix is marketed jointly by Bristol-Myers Squibb Co. and Sanofi SA. The drug makers are now offering coupons for huge discounts off the brand price, said CBS/AP. Plavix typically costs about $200 per month.

The FDA said that the 75-milligram generic version of Plavix can be sold by Apotex Corp., Aurobindo Pharma, Mylan Pharmaceuticals, Roxanne Laboratories, Sun Pharma, Teva Pharmaceuticals and Torrent Pharmaceuticals. The 300-milligram dose can be sold by Dr. Reddy’s Laboratories, Gate Pharmaceuticals, Mylan, and Teva, said CBS/AP. The generics are expected to be immediately available in pharmacies and will cost about $40 per month or a $10 co-payment, with insurance, said CBS/AP.

Meanwhile, national law firm, Parker Waichman LLP, has just filed several new lawsuits on behalf of individuals who allegedly injured by life-threatening Plavix bleeding side effects. Each alleges that use of Plavix caused the plaintiffs to suffer serious gastrointestinal bleeds.

This is not the first time patients have complained of side effects from the popular blood thinner. Parker Waichman LLP filed an additional six Plavix bleeding lawsuits on April 30, 2012, also in the Supreme Court of the State of New York, County of New York. Those complaints also allege that the plaintiffs’ use of Plavix caused them to suffer from a number of bleeding side effects, including gastrointestinal hemorrhage, cerebral hemorrhage, and the blood condition TTP. The FDA first approved Plavix (clopidogrel) in 1997 for the prevention of heart attack and stroke.

The Plavix lawsuits filed by Parker Waichman LLP claim that defendants Bristol-Myers Squibb and Sanofi-Aventis falsely touted the drug as being more effective and safer in reducing the risk of ischemic events versus a less expensive daily aspirin regimen.

The lawsuits allege that Plavix users are at a significantly increased risk for suffering serious, dangerous, and potentially fatal side effects that include heart attack, stroke, internal bleeding, blood disorder, and/or death. The complaints further allege that Plavix use caused severe and permanent personal injuries; physical pain; mental anguish, including diminished enjoyment of life and fear of developing other health consequences; and the need for lifelong medical treatment, monitoring, and/or medications. Plavix has also been linked to dangerous side effects that include ulcers and bone marrow damage.

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