Company Failed to Check Out Patient’s Drug Complaint, FDA Says

A Texas drugmaker was flagged by the FDA for failing to follow up on a patient’s complaint.

The company, Neos Therapeutics, of Grand Prairie, did not investigate a complaint of dizziness and difficulty sleeping after taking Adzenys (amphetamine), an extended-release tablet for treating attention deficit hyperactivity disorder in patients 6 years and above.

The company also did not document why it didn’t look into the complaint, the FDA said in a Form 483 report.