22 May 2023 – Congratulations to Indivior on the US FDA approval of their opioid overdose rescue medication for natural and synthetic opioids, OPVEE® (nalmefene) Nasal Spray. PLC has been involved with the regulatory development of this product from the early stages with both Opiant Pharmaceuticals, the previous holder of OPVEE, and Indivior. OPVEE was
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
13 January 2020 – Congratulations to Neurelis on their recent NDA approval for seizure rescue treatment VALTOCO® (Diazepam nasal spray). PLC has supported the clinical development and regulatory pathway of VALTOCO from the beginning and supported their IND and NDA filings. In addition, PLC supported the development and filing of the Orphan Drug Exclusivity for
06 March 2017 – PLC is proud to announce Izun Pharmaceuticals has received FDA approval of their 510(k) application for Curastie™ Hydrogel Wound Care. PLC directed the preparation and filing of the 510(k) application on Izun’s behalf. Izun Pharmaceuticals Announces Approval of Curasite™ Hydrogel Wound Care Product by FDA Product approved for prescription and over
22 December 2015 – PLC wishes to congratulate Neurelis on their recent approval of Orphan Drug Designation for NRL-1. PLC has worked with Neurelis on the clinical and regulatory pathway of NRL-1 from its early stages and filed the Orphan Drug Designation application on behalf of Neurelis to the US FDA. NEURELIS RECEIVES FDA ORPHAN