Watson files lawsuit against FDA claiming approval delays for its generic version of Actos
The US Food and Drug Administration (FDA) has approved the first generic version of Takeda Pharmaceutical’s Actos (pioglitazone hydrochloride) tablets for the treatment of type 2 diabetes.
Actos works by decreasing insulin resistance, and is approved for use in the US to improve glycemic control, alongside diet and exercise.
‘Controlling blood sugar levels is very important in preventing or reducing the long-term health complications of diabetes,’ said Gregory Geba, director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research.
‘Generic versions of this widely used product will offer affordable treatment options for patients who must manage this chronic and potentially serious condition.’
Mylan Pharmaceuticals, based in Morgantown, West Virginia, US has been granted 180-day marketing exclusivity on 15mg, 30mg and 45mg pioglitazone tablets.
Pioglitazone tablets had US sales of approximately US$2.7bn for the 12 months ending 30 June, according to IMS Health. Watson Pharmaceuticals had been hoping to launch its own version of Actos tablets on 17 August, but claims it was held back by the FDA, against which it has filed a lawsuit.
Watson says the FDA ‘improperly denied it’ a share of the 180-day exclusivity, and that as a result its abbreviated new drug application (ANDA) could be delayed by up to six months.
Paul Bisaro, Watson’s president and ceo, said: ‘The FDA has refused to grant shared exclusivity, and seeks unnecessarily to 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.’