Page updated ·next FDA decision on the calendar·Data as of Nov 5, 2026 5:03 AM ET
FDA decision (PDUFA) target Nov 14, 2026 · Teva Pharmaceutical Industries (acquired from BioXcel Therapeutics, Oct 26, 2026) · At-home agitation in bipolar disorder or schizophrenia (sNDA)
Source: BioXcel Therapeutics, Inc. 8-K 2026-05-15. “…New Drug Application (sNDA) for IGALMI for at-home use in the acute treatment of agitation associated with bipolar disorders or schizophrenia and assigned a PDUFA target action date of November 14, 2026”
Key facts
FDA PDUFA target date2026-11-14
Drug / candidateIGALMI (dexmedetomidine sublingual film)
IndicationAt-home agitation in bipolar disorder or schizophrenia (sNDA)
CompanyTeva Pharmaceutical Industries (acquired from BioXcel Therapeutics, Oct 26, 2026)
The FDA PDUFA target date for TEVA (Teva Pharmaceutical Industries (acquired from BioXcel Therapeutics, Oct 26, 2026)) is 2026-11-14 for IGALMI (dexmedetomidine sublingual film). Dates are company/FDA-sourced and can slip. Verify against primary filings.
What is TEVA's drug IGALMI?
IGALMI (dexmedetomidine sublingual film) is Teva Pharmaceutical Industries (acquired from BioXcel Therapeutics, Oct 26, 2026)'s candidate under FDA review for At-home agitation in bipolar disorder or schizophrenia (sNDA).