DUSA Pharmaceuticals Inc., a wholly owned subsidiary of Sun
Pharmaceutical Industries Inc. announced that it has reached a resolution with the United States Department of Justice (DOJ) concerning the promotion of LEVULAN® KERASTICK® (aminolevulinic acid HCL) and
BLU-U®.
DUSA fully cooperated with DOJ in its investigation of a complaint filed by a former employee in September 2016.
Under the civil settlement agreements signed with the DOJ, DUSA will pay US$20.75 million to resolve allegations related to the promotion of LEVULAN® KERASTICK® and BLU-U ®. DUSA had already made a provision towards this in its Q4 financials for the year ended March 31, 2020. The settlement does not constitute any admission by DUSA of any liability or wrongdoing.
As part of the resolution, DUSA and SPII have entered into a corporate integrity agreement with the Office of
Inspector General of the U.S. Department of Health and Human Services. This agreement supplements SPII's
existing compliance program, which is based upon established best practices and industry standards as well as the
company's global code of conduct, which can be found here. Under the settlement agreement, the DOJ has
agreed not to bring any action seeking to exclude DUSA or SPII from participating in Federal health care programs.
In a separate agreement, DUSA also fully resolved all allegations made by the former employee.