19 October 2020 – PLC commends Neurelis on their recent FDA approval of extended expiration dating for VALTOCO®. PLC has supported the clinical development and regulatory pathway of VALTOCO from its early development phase and continues to provide clinical oversight of ongoing trials and regulatory support for Neurelis and their drug product development in the US. PLC also supported the development and filing of the Orphan Drug Exclusivity for VALTOCO to the US FDA.
NEURELIS ANNOUNCES FDA APPROVAL OF EXTENDED EXPIRATION DATING FOR VALTOCO® (DIAZEPAM NASAL SPRAY)
https://neurelis.com/neurelis-news/fda-approval-extended-expiration-dating