Submit a New Drug Application to the FDA for XULANE LO low dose weekly dermal patch
Delivered by the deadline
AI-confirmed · human review in progress Independent AI checks agreed on primary SEC or regulator evidence. Records are now being reviewed by hand, starting with those our customers order.
- Announced
- 8 May 2025
- Due
- 31 Dec 2025
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“The Company plans to submit an NDA to the FDA in the second half of 2025.”
What we found
Evidence strength A What the grades mean
A December 2025 FDA acceptance for review of the NDA for the low-dose estrogen weekly patch implies the submission occurred by the year-end 2025 deadline; the exact submission date is not stated.
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A Viatris 8-K filed 2026-02-26
“In December 2025, the Company announced that the FDA accepted for review the New Drug Application (NDA) for the Company's investigational low-dose estrogen weekly patch (150 mcg norelgestromin and 17.5 mcg ethinyl estradiol) for contraception.” ✓ confirmed on the page
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A Viatris 8-K filed 2026-02-26
“The NDA was accepted under the FDA's 505(b)(2) regulatory pathway, and the FDA has assigned a PDUFA goal date of July 30, 2026.” ✓ confirmed on the page
Market reaction: the shares moved -1.4% against the S&P 500 over the three sessions around the disclosure (25 Feb 2026 to 2 Mar 2026). What this measures
Checked 11 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 submission
- Indicative materiality
- High rules
- Action
- Submit
- Deliverable
- XULANE LO New Drug Application
- Where
- United States
- Language
- Expected (“expects”, “plans”)
- 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.
- Second check: agreesA different AI model, Gemini (Google), re-read the evidence without being told the outcome and reached the same answer.
Confirmed. This outcome counts towards the company's Kept Score. How verification works
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Report an error in this entry Reference: KI-C-2025-VTRS-006570 · Corrections policy