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Drugmaker Sues FDA for Rights to Sell Generic Actos

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Watson Pharmaceuticals, one of three drugmakers set to introduce the generic form of Actos, sued the U.S. Food and Drug Administration (FDA) to gain approval for its version of the type 2 diabetes medication.

The generic drugmaker had planned to launch its version of Actos (pioglitazone) on Friday, Aug. 17, following a 2010 settlement that allowed three companies, including Watson, shared marketing exclusivity for 180 days after the drug goes off patent. That means that the three companies alone would be allowed to sell the drug exclusively through December. Now, the FDA won’t grant Watson the exclusivity, which would  keep the company from selling the drug for six months.

Following FDA Rules

Without disclosing the details of the FDA dispute, Watson executives said it followed the FDA’s rules to sell the drug. Watson’s lawsuit argues that the company filed paperwork in a timely manner but the FDA still denied the company’s right to sell the drug in a shared-exclusivity agreement. The company said that the FDA “improperly denied the company’s shared exclusivity,” according to Reuters. The company is going to court to try to force the FDA to allow it to launch a generic Actos.

“We believe that we have sound arguments that refute FDA’s position and will seek the court’s intervention to enable approval,” Watson CEO Paul Bisaro said in a written statement.

In 2010, Actos manufacturer Takeda Pharmaceuticals gave Watson, Mylan Inc. and Ranbaxy Laboratory shared exclusivity rights. For these three companies, this means big bucks considering the drug had total U.S. sales near $3 billion in just the past year. Once that 180-day time frame ends, other companies are already lined up with their own versions of generic Actos. In a press release, Watson tried to calm its investors by saying it believes it can still hit the 2012 projected earnings.

Severe Side Effects of Actos

The newest twist in the long-continuing saga surrounding Actos and pioglitazone underscores how the drug will continue to be a cash cow for Big Pharma worldwide. Meanwhile, questions remain over the Actos tie to bladder cancer, congestive heart failure and other debilitating side effects. By the end of 2012, Takeda will have finished its study reviewing the drug’s tie to bladder cancer. Even though those results won’t be available until 2013, several independent studies have shown a marked increase in bladder cancer risk for those taking the drug for longer than 12 months.

Already, hundreds of injured patients have filed lawsuits in courtrooms nationwide. In the multidistrict litigation based in Louisiana, recent legal filings give a preview of how the cases may play out in court. The judge overseeing the case recently signed an order protecting the confidentiality of discovery materials. Some of the things that fall under the confidential protection order are Takeda’s unpublished clinical studies, production information and information concerning competitors. The judge has also set dates for the first test trials to begin in late 2014 and early 2015. These trials are aimed at showing attorneys on both sides how future cases will proceed.

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