Is neurocept an FDA-approved medication or a dietary supplement?

1. What the available reporting covers — and what it doesn’t

The supplied documents focus on FDA calendars, PDUFA dates and lists of recent 2025 approvals and expected decisions; they include Drugs.com new approvals and FDA pages on novel drug approvals but none reference a product or company named Neurocept. Because the search results you supplied revolve around FDA decision schedules and 2025 approvals, they establish the reporting context but do not provide any direct information about Neurocept ^{[1] [2] [3]}.

2. Why absence in these sources matters

Major public records of FDA approvals and recent drug approvals (Drugs.com listings and FDA “Novel Drug Approvals” pages) are the primary, citable places to confirm whether a product has an FDA drug approval. The absence of Neurocept from those sources in your dataset means we cannot conclude it is FDA‑approved from the supplied reporting; we also have no evidence here that it exists as a marketed dietary supplement ^{[2] [3]}.

3. How to read FDA and industry lists for status clues

When a company gains FDA approval the action typically appears on the FDA’s approvals pages and aggregated trackers like Drugs.com or specialty outlets that compile PDUFA calendars. Your supplied items show that these outlets are being used for tracking approvals (including PDUFA dates and recent approvals), so a missing product in these sources is a signal — in this dataset — that approval status for Neurocept is not documented here ^{[1] [2] [3]}.

4. Possible alternative explanations (based on standard patterns)

There are several common reasons an item might not appear on these lists: the product may be pre‑clinical or in clinical trials (not yet filed or under review), the product name could be different from its corporate or chemical name, it could be a dietary supplement that is not reviewed/approved by FDA as a drug, or it may be marketed outside the U.S. The provided sources list products that have reached FDA review/approval stages and those under review; they do not confirm any of these alternatives for Neurocept ^{[1] [3]}.

5. What you should do next to get a definitive answer

To determine whether Neurocept is FDA‑approved or a dietary supplement you need to check primary sources not in this dataset: the FDA’s Drugs@FDA database, the FDA Center for Food Safety and Applied Nutrition (CFSAN) dietary supplement notifications, and company regulatory filings or press releases. The supplied materials point to Drugs@FDA / FDA novel approvals as the authoritative registries for approvals; because Neurocept isn’t in your supplied results, consulting those primary registries is the necessary next step ^{[3] [2]}.

6. Caveats, competing perspectives and hidden agendas to watch for

Industry press and paid news aggregators often preview expected approvals and PDUFA dates (as the supplied items do), but they can omit smaller companies or products with different naming conventions ^{[1] [4]}. If a company or vendor markets a product as a treatment but it lacks an FDA approval listing, the seller has incentive to emphasize alternative claims (supplement status, compassionate‑use or investigational use). The supplied articles do not discuss Neurocept, so any promotional claims about approval or supplement status are not supported by these sources (available sources do not mention Neurocept) (p1_s1–^[1]5).

7. Bottom line for a reader seeking to rely on this dataset

From the materials you gave me — FDA calendars, Drugs.com approval lists and healthcare‑trade coverage of 2025 regulatory actions — there is no evidence here that Neurocept is FDA‑approved as a medication or documented as a dietary supplement; the sources simply do not mention it (available sources do not mention Neurocept) (p1_s1–^[1]5). For a definitive determination, consult the FDA’s approval database and the company’s regulatory filings directly; those authoritative registries are cited in the provided coverage as the places to verify approvals ^{[3] [2]}.