Granted through the small business waiver provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the waiver will save Cingulate approximately $4.3 million as the company prepares to submit its NDA at the end of this month.
"We are pleased to receive this significant waiver as we approach the submission of our NDA in the coming days and look forward to continuing to work with the FDA throughout the submission and review process," said Cingulate Chairman and CEO Shane J. Schaffer. "This waiver will save Cingulate more than $4 million and strengthen our financial position as we prepare to commercialize CTx-1301."
About Attention Deficit/Hyperactivity Disorder (ADHD)ADHD is a chronic neurobiological and developmental disorder that affects millions of children and often continues into adulthood. The condition is marked by an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development. In the U.S., over 20 million patients have been diagnosed with ADHD. Among this group, 12 million are adults and over 8 million are under the age of 17. According to the CDC, just 53.6 percent of all children and teens with ADHD reported they were actively treating their symptoms with medication in 2022, with 65–90 percent demonstrating clinical ADHD symptoms that persist into adulthood. Current market trends demonstrate that adult ADHD prevalence ...
