Has the FDA approved gelatide for any medical uses as of 2025?
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Executive summary
Available FDA databases and 2025 approval roundups in the provided sources list many new drug approvals and review calendars but do not mention any product named “gelatide” as approved by the FDA through 2025; none of the cited FDA pages, news recaps, or industry trackers list gelatide among novel drug approvals or orphan-drug PDUFA items [1] [2] [3] [4].
1. What the official FDA records and 2025 approval roundups show — and don’t show
Comprehensive FDA approval pages and industry summaries from 2024–2025 document dozens of novel approvals and the agency’s searchable databases for approvals and labels, but the supplied FDA “Novel Drug Approvals” pages and CDER database links make no mention of a product called gelatide among listed approvals [1] [2]. Independent trackers and press summaries that recap multiple 2025 approvals (for example, semaglutide, suzetrigine and pediatric epinephrine spray) also do not list gelatide [4] [3].
2. Why absence from these lists matters — how approvals are normally recorded
When the FDA approves a new drug, it appears in Drugs@FDA and in CDER’s “Novel Drug Approvals” summaries and is widely reported by health press and industry trackers [1] [2]. The sources you provided include such repositories and multiple independent recaps of 2025 approvals; gelatide does not appear in any of them, which indicates it is not recorded among the documented FDA approvals in these sources [1] [4].
3. Possible explanations for why gelatide isn’t listed in these sources
There are several nonexclusive reasons a name might be absent from public approval lists: the product may not have been submitted to the FDA; the application could be pending, withdrawn, or rejected; it could be an alternate trade name not used in FDA filings; or it may be a non-U.S. product not seeking FDA approval. The supplied reporting and databases discuss accepted NDAs, priority reviews, and PDUFA calendars — tools where an actively reviewed product would normally appear — but none of the provided items mention gelatide in those contexts [3] [5] [6].
4. What the sources say about where to check and next steps for verification
The FDA’s Drugs@FDA and CDER databases are the authoritative public records for approvals and labels; the Novel Drug Approvals pages and Drug Approvals & Databases landing page pointed to in the provided sources are the places to confirm approvals and prescribing information [1] [2]. For an authoritative determination about gelatide, consult Drugs@FDA or the FDA’s approval announcements directly; the sources you supplied recommend those repositories for definitive prescribing information [1] [2].
5. Limitations of this check and what we cannot conclude from these sources
Available sources do not mention any FDA approval status for gelatide, but they also do not document every FDA submission, CRL, or company press release that might reference gelatide; absence from the supplied summaries is strong but not absolute proof of no activity outside these records [1] [2] [3]. The provided materials include high-level approval lists and 2025 news recaps but do not contain a full audit of every regulatory interaction or non-U.S. approvals [1] [4].
6. How to proceed if you need a definitive answer
Check the FDA’s Drugs@FDA database and the CDER Novel Drug Approvals pages for gelatide and the latest prescribing information; those are explicitly cited as the authoritative sources in the FDA pages included above [1] [2]. If an FDA decision is expected, monitor PDUFA calendars and specialty reporting that list accepted applications and review deadlines [3] [5] [6].
Summary: based on the FDA pages and 2025 approval roundups provided, gelatide is not listed as an FDA‑approved product through 2025 [1] [2] [3] [4].