Watson Pharmaceuticals has filed a lawsuit against the FDA for denying shared exclusivity, despite the fact that the drug company followed all the FDA’s requirements.
Watson planned to release the generic version of Takeda Pharmaceutical’s controversial Actos drug on August 17th. In 2010, Watson got approval to market the generic pioglitazone hydrochloride from the Japanese drug company, along with Mylan Inc and India’s Ranbaxy Laboratories. The first company to file for approval of an off-patent drug gets exclusive marketing rights for 180 days.
President and CEO of Watson, Paul Bisaro, said: “When we learned of FDA’s position regarding our application, we made efforts to work cooperatively with FDA to resolve the situation. FDA has refused to grant shared exclusivity, and seeks to unnecessarily delay the launch of Watson’s generic Actos product, with potential harm to consumers who may face constraints on supply as a result of this action. We believe that we have sound arguments that refute FDA’s position and will seek the court’s intervention to enable approval.”
Watson Pharmaceuticals has filed this lawsuit at a time when Actos, manufactured by Takeda Pharmaceuticals, is under heavy fire from patients claiming the diabetes drug caused severe complications. Recent studies have linked use of Actos for 2 years or more to an increased chance of developing bladder cancer, as well as heart disease, liver failure, and diabetic macular edema.
If you or a loved one has taken Actos to treat your Type 2 diabetes, and you have now been diagnosed with serious health issues, you may be entitled to compensation. The experienced lawyers at Strom Law, LLC, are accepting cases nationwide against Actos. Please contact us today for a free consultation to discuss the facts of your case. 803.252.4800.