2023-11-28-Orexo announces FDA acceptance of New Drug …
WEBUppsala, Sweden – November 28, 2023 – Orexo AB (publ.), (STO:ORX) (OTCQX:ORXOY), today announces the New Drug Application (NDA) for OX124 has been accepted for review by the US Food and Drug Administration (FDA). OX124 is a nasal rescue medication for opioid overdose containing a high dose of naloxone and is the first product based on Orexo ...
Orexo announces FDA acceptance of New Drug Application filing …
WEBNov 28, 2023 · OX124 will meet the growing need for more powerful medications to improve the possibility of reviving individuals experiencing an overdose caused by use of synthetic opioids, such as fentanyl ...
Orexo shares new information on OX124, a high-dose naloxone …
WEBJul 16, 2024 · Orexo AB (publ.), (STO: ORX) (OTCQX: ORXOY), today announces that the company has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding the New Drug...
Pressreleases and News - Orexo
WEBMay 7, 2024 · News Release – Uppsala, Sweden, September 29, 2023. The year of 2023 marks 10 years on the US Pharma market for Orexo. In September 2013, after conscientious preparations and an FDA approval, ZUBSOLV®, became available for patients across the US.
Orexo shares new information on OX124, a high-dose naloxone …
WEBJul 16, 2024 · The requirement from FDA to provide additional technical data was unexpected, and Orexo will now work expeditiously in consultation with the FDA to address this to enable a resubmission of...
Orexo announces FDA acceptance of New Drug Application filing …
WEBNov 28, 2023 · Orexo AB (publ.), (STO: ORX) (OTCQX: ORXOY), today announces the New Drug Application (NDA) for OX124 has been accepted for review by the US Food and Drug Administration (FDA).
Orexo submits New Drug Application to FDA for OX124, a high
WEBSep 18, 2023 2:37am EDT. OX124 is based on Orexo´s world-class drug delivery platform amorphOX® and is designed to reverse the effect of the most powerful synthetic opioids, such as fentanyl....
Orexo submits New Drug Application to FDA for OX124, a high …
WEBUPPSALA, Sweden, Feb. 3, 2023 /PRNewswire/ -- Orexo AB (publ.), (STO: ORX) (OTCQX: ORXOY), today announces the submission of a New Drug Application (NDA) to the US Food and Drug Administration...
Orexo announces FDA acceptance of New Drug Application
WEBNov 28, 2023 · Orexo announces FDA acceptance of New Drug Application filing for OX124, a high-dose rescue medication for opioid overdose. Published: Nov 28, 2023. OX124 is based on Orexo´s world-class drug delivery platform, amorphOX®, and is designed to reverse the effects of the most powerful synthetic opioids, such as fentanyl.
FDA issues CRL to Orexo’s NDA for opioid overdose medication
WEBJul 17, 2024 · The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to Orexo regarding a new drug application (NDA) for its high-dose naloxone rescue medication, OX124, designed to counteract opioid overdoses. The company submitted the NDA to the FDA in September 2023.