Submit FINTEPLA application for Lennox-Gastaut syndrome in the U.S
Delivered by the deadline
AI-assessed · human review in progress Found and assessed by AI from the cited sources. Shown with its evidence; it is not counted in any Kept Score until confirmed.
- Announced
- 25 Feb 2021
- Due
- 30 Sep 2021
- Delivered
- September 2021
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“On track to submit applications for FINTEPLA in Lennox-Gastaut syndrome in the U.S. in Q3 2021”
What we found
Evidence strength A What the grades mean
Later filings say the U.S. sNDA for FINTEPLA in LGS was submitted to the FDA in late September 2021, before the Q3 2021 deadline. One 10-K describes the U.S. submission as fourth-quarter 2021.
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A Zogenix, Inc. 8-K filed 2021-11-04
“Submitted a supplemental NDA (sNDA) to the FDA in late September” ✓ confirmed on the page
-
A Zogenix, Inc. 10-K filed 2022-03-01
“In September and December 2021, we submitted a supplemental new drug application (sNDA) for LGS to the FDA” ✓ confirmed on the page
-
A Zogenix, Inc. 10-K filed 2022-03-01
“In the fourth quarter of 2021, we submitted applications in the U.S. and in the EU” ✓ confirmed on the page
Checked 27 Oct 2026.
Commitment DNA
The structured record of this commitment. Fields the company did not state are left blank rather than guessed.
- Event type
- Regulatory filing
- Indicative materiality
- Medium rules
- Action
- Submit
- Deliverable
- FINTEPLA Lennox-Gastaut syndrome U.S. application
- Where
- United States
- Language
- Firm (“will”, “on track to”)
- In the company’s control
- High
- Specificity
- High
How this entry was checked
- Commitment recordedThe company's words were matched word for word against the filing.
- First checkAn AI model, Claude (Anthropic), read the company's later filings and recorded the outcome with a quoted passage.
Not yet confirmed. Shown on the record, but it will not count in any score until it is confirmed. How verification works
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