PharmaTher Holdings announced it has submitted a priority original Abbreviated New Drug Application, or ANDA, for KETARX, or racemic ketamine, to the FDA for expedited review of its ANDA. The Company anticipates KETARX approval and commercial launch in the U.S. in Q2-2024, followed by the pursuit of international approvals to support the growing global demand for ketamine. Ketamine is an essential medicine used for anaesthesia and analgesia listed on the WHO Essential Medicines List. Ketamine has been on the FDA’s drug shortage list since February 2018.
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
See today’s best-performing stocks on TipRanks >>
Read More on PHRRF:
- PharmaTher Submits Priority Original Abbreviated New Drug Application for KETARX™ (Ketamine) to the FDA
- PharmaTher to invest C$300,000 in Sairiyo Therapeutics for 49% ownership
- PharmaTher Announces Positive Research Results for PharmaPatch™ with N,N-dimethyltryptamine (DMT) and Strategic Investment into Sairiyo Therapeutics
- PharmaTher announces research results for PharmaPatch with DMT
