Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing
🏛 Food and Drug Administration (FDA)FDA-2022-N-2390
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Rules, notices, and supporting material — the primary rule pinned first.
📄 Primary document
- Other· Jul 22, 2026No comment period
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- Other· Jul 22, 2026No comment period
- Other· Jul 22, 2026NEA→No comment period
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- Other· Jul 6, 2026No comment period
- Other· Jun 30, 2026No comment period
- Notice· Jun 3, 2026Closed on Jul 7, 2026