GALDERMA LABS LP
Latisse — FDA approval record and published evidence
ABBVIE · Skin & Topicals · Bimatoprost for eyelash growth
Methodology →NDA · approved
Methodology →—
Methodology →18
Methodology →128
Methodology →28
An NDA product is approved, not cleared — the drug route, not the device one. What this measuresAn NDA is a new drug application. FDA approved the drug; approved, not cleared. The original approval can long predate any cosmetic indication, and Drugs@FDA does not publish a per-indication date. It measures how much has been published about a technique. It is not a quality score, not an efficacy measure, not a count of randomised trials, and not comparable between modalities of different ages. It says nothing about this brand specifically.
Methodology →
Overview
- Modality
- Bimatoprost for eyelash growth
- Manufacturer
- ABBVIE
- Category
- Skin & Topicals
- Latest decision
- FDA records
- 1
- Mapping
- Verified
Mapping is the weakest link on this page; the rule is published. What this measuresMatched openFDA Drugs@FDA application NDA022369 (NDA). first_decision_date is the ORIGINAL approved submission; latest_decision_date is the most recent approved submission of any type (including supplements for new indications). NOTE: the original approval may predate the COSMETIC indication -- Drugs@FDA does not expose per-indication dates, so this file does not claim one. A mapping is the weakest link on this page: if it is wrong, every number above it is about the wrong product. It is stated in full so it can be checked.
Methodology →
Regulatory
| Identifier | Type | Role | FDA record |
|---|---|---|---|
| NDA022369 | NDA — approved | Primary | Open → |
Approved indication: not transcribed here — read it on NDA022369 → Approved indicationopenFDA's release of this database does not return the indications-for-use text, and this Index will not paraphrase a regulatory statement it has not transcribed. An NDA is a new drug application. FDA approved the drug; approved, not cleared. The original approval can long predate any cosmetic indication, and Drugs@FDA does not publish a per-indication date.
Methodology →
Evidence
Counted for the modality, never the brand.
| Bimatoprost for eyelash growth | |
|---|---|
| 2016 | 6 |
| 2017 | 6 |
| 2018 | 5 |
| 2019 | 5 |
| 2020 | 6 |
| 2021 | 4 |
| 2022 | 8 |
| 2023 | 5 |
| 2024 | 7 |
| 2025 | 7 |
| 2026 | 3 |
PubMed counts publications; ClinicalTrials.gov counts registrations. Neither is a quality score. What this measuresPubMed record counts and ClinicalTrials.gov study counts for a fixed query about the MODALITY, never the brand. It measures how much has been published about a technique. It is not a quality score, not an efficacy measure, not a count of randomised trials, and not comparable between modalities of different ages. It says nothing about this brand specifically. Registration is not completion, not publication and not a result. Counts include studies of any status, size or sponsor, and the recruiting figure is a snapshot taken on the run date. Device studies are under-registered relative to drug studies. The trend line is the same fixed modality query windowed per publication year. Number of PubMed records matching each modality's fixed, hand-written title/abstract query, windowed to a single publication year. It measures publication volume about a TECHNIQUE, not a brand. It is NOT a quality score, NOT an efficacy measure, and NOT a count of randomised trials. 2026 is a partial year (run date 2026-07-26); its bar is short because the year is short, not because interest fell. 2026 contains only papers indexed by the run date (2026-07-26). Render it visually distinct (e.g. hollow/hatched) or annotate it; never let it read as a decline.
Methodology →
PubMed query, verbatim
(bimatoprost[tiab] OR "prostaglandin analog"[tiab]) AND (eyelash*[tiab] OR hypotrichosis[tiab] OR "lash growth"[tiab])
ClinicalTrials.gov query, verbatim
intervention: (bimatoprost) condition: ("eyelash hypotrichosis" OR eyelashes OR hypotrichosis OR cosmetic)
Treatment areas
What matched, and where
| Area | Matched term | Source string |
|---|---|---|
| Eyelashes | eyelash | ClinicalTrials.gov condition query for Bimatoprost for eyelash growth |
Derived by keyword rule, not the cleared or approved indication. What this measuresTreatment areas are DERIVED, not copied from an FDA field. A fixed keyword list is run over two real strings: the ClinicalTrials.gov condition query actually executed for this product's modality on the run date, and the device names of the FDA product codes attached to this product's records. The words "skin" and "cosmetic" are ignored because every query contains one of them. An area is not the cleared or approved indication — openFDA's 510(k) response does not carry the indications-for-use text, and this Index does not paraphrase it.
Methodology →
Sources
- openFDA query run for this producthttps://api.fda.gov/drug/drugsfda.json?search=openfda.brand_name:%22LATISSE%22&limit=10
- FDA public record for NDA022369https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022369
- PubMed count, all timehttps://eutils.ncbi.nlm.nih.gov/entrez/eutils/esearch.fcgi?db=pubmed&retmode=json&rettype=count&term=%28bimatoprost%5Btiab%5D%20OR%20%22prostaglandin%20analog%22%5Btiab%5D%29%20AND%20%28eyelash%2A%5Btiab%5D%20OR%20hypotrichosis%5Btiab%5D%20OR%20%22lash%20growth%22%5Btiab%5D%29
- PubMed count, last 10 yearshttps://eutils.ncbi.nlm.nih.gov/entrez/eutils/esearch.fcgi?db=pubmed&retmode=json&rettype=count&term=%28bimatoprost%5Btiab%5D%20OR%20%22prostaglandin%20analog%22%5Btiab%5D%29%20AND%20%28eyelash%2A%5Btiab%5D%20OR%20hypotrichosis%5Btiab%5D%20OR%20%22lash%20growth%22%5Btiab%5D%29%20AND%20%28%222016%2F01%2F01%22%5Bdp%5D%20%3A%20%222026%2F12%2F31%22%5Bdp%5D%29
- ClinicalTrials.gov, all studieshttps://clinicaltrials.gov/api/v2/studies?query.intr=%28bimatoprost%29&query.cond=%28%22eyelash%20hypotrichosis%22%20OR%20eyelashes%20OR%20hypotrichosis%20OR%20cosmetic%29&countTotal=true&pageSize=1&fields=NCTId
- ClinicalTrials.gov, recruiting onlyhttps://clinicaltrials.gov/api/v2/studies?query.intr=%28bimatoprost%29&query.cond=%28%22eyelash%20hypotrichosis%22%20OR%20eyelashes%20OR%20hypotrichosis%20OR%20cosmetic%29&filter.overallStatus=RECRUITING&countTotal=true&pageSize=1&fields=NCTId
No adverse-event data is published anywhere on this site. What this measuresNo adverse-event data appears anywhere on this site. MAUDE and FAERS were never queried: those counts have no denominator, reporting is voluntary and duplicated, and a report is not evidence of causation. Publishing them beside a brand name would mislead.
Methodology →