21 October 2022 – PLC congratulates ARS Pharmaceuticals on their recent announcement of FDA acceptance of the NDA for neffy® for the treatment of allergic reactions including anaphylaxis. PLC filed the NDA on ARS Pharmaceuticals’ behalf and has supported Regulatory filings and clinical oversight since the program’s inception. ARS Pharmaceuticals announces FDA acceptance of NDA
24 September 2018 – PLC is pleased to announce that a New Drug Application for seizure rescue treatment VALTOCO® (Diazepam nasal spray) has been filed on behalf of Neurelis with the US FDA. PLC has supported Neurelis with VALTOCO from program inception and supported their IND filings, clinical development programs and provided clinical oversight for
29 July 2015 – PLC would like to recognize Adapt Pharma and Lightlake Therapeutics, partners developing a naloxone-based nasal spray for opioid overdose reversal, on their recent NDA submission to the US FDA. PLC has worked with both Adapt and Lightlake on their US regulatory filings and submitted the NARCAN® (naloxone hydrochloride) nasal spray NDA