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# J&J Subsidiary Pays $10 Million on Drug/Device Promo Violations
- URL: https://www.fdaweb.com/j-j-subsidiary-pays-10-million-on-drug-device-promo-violations/
- Published: 2020-11-20T12:00:00.000Z
- Updated: 2026-09-14T16:37:23.000Z
- Author: David McFarland
- Tags: Drugs, FDA Policy/General, Devices, #legacy-id-D5148137

Johnson & Johnson (J&J) subsidiary Medical Device Business Services has agreed to pay $10 million to settle allegations under the False Claims Act that former J&J subsidiary Therakos promoted Uvar XTS and Cellex extracorporeal photopheresis systems for unapproved uses in pediatric patients between 2006 and 2012\. The Gores Group also agreed to pay an additional $1.5 million to resolve allegations that Therakos continued those alleged improper sales and promotion practices after it acquired Therakos from J&J in 2012, according to a Justice Department [release](https://www.justice.gov/usao-edpa/pr/former-owners-therakos-inc-pay-115-million-resolve-false-claims-act-allegations?ref=fdaweb.com#:~:text=%28%E2%80%9CMDBS%E2%80%9D%29%20agreed%20to,patients%20between%202006%20and%202012.).  

In 1999, FDA approved Uvadex, the drug administered by the Therakos systems, for “the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma that is unresponsive to other forms of treatment.” The government alleges that between 2006 and 2015, Therakos marketed and promoted its systems to treat pediatric patients for indications that were not approved by FDA. It says that the drug and devices were not approved for use in the pediatric population.