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PITTSBURGH — Mylan has launched a generic drug for preventing rejection of transplanted organs, the company said Thursday.
The generic drug maker announced the launch of mycophenolic acid delayed-release tablets in the 180-mg and 360-mg strengths. The drug is a generic version of Novartis' Myfortic. As the first company to file a completed regulatory approval application for the generic, Mylan is entitled to 180 days in which to compete exclusively against Novartis' product before the Food and Drug Administration can approve additional generic versions.
The drug is used to prevent rejection of transplanted kidneys in adults and in children ages 5 years and older who are taking the drug at least six months after a transplant operation. Myfortic had sales of about $306.8 million during the 12-month period that ended in September, according to IMS Health.