FDA Hands Mallinckrodt Letter of Non-Compliance With PREA

The FDA has handed Mallinckrodt Pharmaceuticals a non-compliance letter after the firm failed to submit a pediatric assessment under the post-marketing requirements for its opioid Xartemis XR.

The notice states that the company’s failure to conduct the assessment violates the Pediatric Research Equity Act and gives the company 45 days to respond.