Upcoming PDUFAs in February 🗓️
Following approvals of JOURNAVX (Vertex) and SYMBRAVO (Axsome) last week, the FDA approved ONAPGO (Supernus) today! Three more PDUFAs are expected this February. See the summary below for details.
🗓️ Last Week’s PDUFAs:
VRTX: Approved ✅
➯ JOURNAVX (suzetrigine)
» Non-opioid pain signal inhibitor
» Indication: Moderate-to-severe acute pain
» PDUFA date: 1/30/25 (NDA)
AXSM: Approved ✅
➯ SYMBRAVO (meloxicam & rizatriptan) (AXS-07)
» NSAID & 5-HT1B/1D agonist combination
» Indication: Migraine
» PDUFA date: 1/31/25 (Resubmitted NDA)
SUPN: Approved ✅
➯ ONAPGO™ (apomorphine hydrochloride)
» subcutaneous apomorphine infusion device
» Indication: Parkinson’s Disease
» PDUFA date: 2/1/25 (NDA)
📌 Upcoming PDUFAs in February:
Check out the January & February PDUFA calendar below. 👇
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Article History:
MV/AV/DG (2/4/25)
This article is not investment, tax, or legal advice. Please do your own diligence and seek advice from professional advisors representing your interests.