DUSA Pharmaceuticals, (DUSA), a wholly-owned subsidiary of Sun Pharmaceutical Industries 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.
The DOJ investigation was initiated after a complaint was filed by a former employee in September 2016.
“Under the civil settlement agreements signed with the DOJ, DUSA will pay $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,” said the company in a statement.
As part of the resolution, DUSA and SPII have entered into a corporate integrity agreement with the Office of Inspector General of the US Department of Health and Human Services. 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.