https://www.citizen.org/news/fda-failures-result-in-wider-approval-of-orphan-medication-for-sleep-disorder/
FDA Failures Result in Wider Approval of Orphan Medication for Sleep Disorder - Public Citizen
Rather Than Correct Labeling Error, FDA Retroactively Issued a Second Approval Letter Changing the Approved Use
result inorphan medicationfor sleeppublic citizenfda