Posted by Michael Wonder on 13 Jan 2020
Aquestive Therapeutics receives FDA response to Citizen’s Petition
12 January 2020 - Aquestive Therapeutics today reported that the U.S. FDA issued a response letter dated 10 January 2020 denying Aquestive’s Citizen’s Petition received by the FDA on 1 November 2019, including the supplement to the Citizen’s Petition received by the FDA on 4 December 2019.
The Petition requested, among other things, that the FDA stay approval of a new drug application for Valtoco (diazepam nasal spray) submitted by Neurelis until additional clinical studies were conducted. In the response, the FDA indicated that it had approved Neurelis’s NDA for Valtoco on 10 January 2020.
Valtoco has received orphan drug exclusivity from the FDA’s Center for Drug Evaluation and Research commencing as of 10 January 2020 for the labeled indication of acute treatment of intermittent stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy six years of age and older.
