Posted by Michael Wonder on 10 Nov 2020
Supernus provides regulatory updates for SPN-812 and SPN-830
9 November 2020 - The U.S. FDA has issued a complete response letter regarding the new drug application for SPN-812 for the treatment of ADHD in paediatric patients 6 to 17 years of age.
The primary issue cited in the SPN-812 complete response letter relates to the Company’s in-house laboratory that conducts analytical testing, which recently moved to a new location.
