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TEVA FDA decision dates

Page updated ·next FDA decision on the calendar ·Data as of Nov 5, 2026 5:03 AM ET

TEVA has 1 upcoming FDA decision date; the nearest is Nov 14, 2026 for IGALMI (dexmedetomidine sublingual film) - (SERENITY At-Home. 7 past decisions are on record below, each on its own page. One event, one page: past decisions never share a URL with a live catalyst.

TEVA catalyst hub · full calendar

Upcoming

Nov 14, 2026 in 9 daysIGALMI (dexmedetomidine sublingual film) - (SERENITY At-Home)

Decided

Oct 8, 2026 ✓ ApprovedWeltruza (olanzapine) extended-release injectable suspensionSep 25, 2026 ✓ ApprovedDegevma (denosumab-adet), biosimilar to and interchangeable with XgevaMar 30, 2026 ✓ ApprovedPONLIMSI (denosumab-adet)Oct 10, 2025 ✓ ApprovedUZEDYAug 28, 2025 ✓ Approvedprice-onlyAug 6, 2025 ✓ ApprovedAJOVYMay 5, 2025 ✓ ApprovedSELARSDI
Facts and dates only; not investment advice. Verify against primary FDA, SEC and company filings. pdufa.bio is not affiliated with the FDA.
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