Watson Received Approval for Generic Actos Drug After Judge Orders FDA to Approve It
Posted Oct 27 2012 11:26pm
It was just in August that Mylan pharmaceuticals received approval for their generic and a court case came afterwards, filed by Watson. Side effects include cold-like symptoms, headache, sinus infection, muscle pain, and sore throat and is a treatment for those with Diabetes 2. Now there’s a second generic of the drug available. It is usually not the first drug of choice though due to side effects and is prescribed as other drugs either don’t work for the patient or another need arises to change drugs.
Mylan may have wanted the market for themselves here but the judge ruled in favor of Watson. ANDA is the product name for the Watson generic of ACTOS. The drug and even the generic versions are not necessarily cheap and a prescription for ACTOS can run over $300.00 but now with one more option for the generic, possibly we could see the price drop. Below is what consumer news has to say. BD
PARSIPPANY, N.J., Oct. 26, 2012 -- /PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) today announced that Watson has launched a generic version of Actos® (Pioglitazone Hydrochloride 15mg, 30mg and 45mg tablets) after receiving final approval today from the U.S. Food and Drug Administration (FDA). Watson began shipping the product immediately.
On August 15, 2012, Watson announced that it had filed suit against the FDA challenging the Agency's decision regarding Watson's entitlement to shared exclusivity for its generic version of Actos®. Mylan Pharmaceuticals, Inc. subsequently intervened as a defendant in the action. On October 22, 2012, the U.S. District Court for the District of Columbia granted summary judgment in favor of Watson and ordered the FDA to approve Watson's ANDA. Mylan appealed the judgment to the U.S. Court of Appeals for the District of Columbia Circuit. The Court of Appeals has denied Mylan's motion for a stay of the judgment pending the appeal.