FDA WARNING_LETTER - Galt Pharmaceuticals LLC - September 13, 2019

The FDA's Office of Prescription Drug Promotion (OPDP) issued a Warning Letter to Galt Pharmaceuticals, LLC (Galt) regarding a professional email (GLT-DOR-016) for DORAL (quazepam) tablets. The email was found to contain false or misleading claims about Doral's risks and efficacy, thereby misbranding the drug and making its distribution violative under the Federal Food, Drug and Cosmetic Act (FD&C Act).

Key violations include: 1. **False or Misleading Risk Presentation:** The email omitted crucial warnings and precautions, such as benzodiazepine withdrawal syndrome, detailed CNS-depressant effects, severe anaphylactic/anaphylactoid reactions, abnormal thinking/behavior changes, and worsening of depression. It also misleadingly minimized abuse and dependence risks by suggesting Doral has a lower abuse potential than other prescription and OTC products, despite being a C-IV controlled substance. 2. **False or Misleading Claims about Efficacy:** The email falsely claimed Doral is the "only marketed medication for Insomnia that helps with all three important components of sleep," when other medications exist. 3. **Omission of Material Facts:** The email omitted information from the Indications and Usage section of the PI, specifically that prolonged administration is generally not necessary or recommended, and that insomnia may be a symptom of other disorders requiring specific treatment.

These violations are particularly concerning due to Doral being a controlled substance with a Boxed Warning