Maker —
No US authorization
Decision—Studies450Trials49
Hylenex recombinant — FDA approval record and published evidence
HALOZYME THERAP · Injectables
BLA · approvedBLA021859
PathwayPathwayA BLA is a biologics licence application. FDA approved the biologic product; approved, not cleared. The application can cover therapeutic indications as well as cosmetic ones, and Drugs@FDA does not publish a per-indication date.
Methodology →BLA · approved
Methodology →BLA · approved
ClassClassDevice class does not apply: this is a drug approved under a BLA, not a device.
Methodology →—
Methodology →—
First approved2005
Years on marketYears on marketDerived: the data run date minus the first matched FDA decision date. Arithmetic on a real date, nothing else.
Methodology →21
Methodology →21
StudiesStudiesPubMed records for a fixed query about the MODALITY, not 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.
Methodology →—
Methodology →—
TrialsTrialsClinicalTrials.gov studies for a fixed query about the MODALITY, not the brand. 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.
Methodology →—
Methodology →—
A BLA product is approved, not cleared — the biologics route, not the device one. What this measuresA BLA is a biologics licence application. FDA approved the biologic product; approved, not cleared. The application can cover therapeutic indications as well as cosmetic ones, 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
- —
- Manufacturer
- HALOZYME THERAP
- Category
- Injectables
- 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(s) BLA021859. first_decision_date is the earliest APPROVED submission across those applications; latest_decision_date is the most recent approved submission of any type, including supplements. Drugs@FDA does not expose per-indication dates, so no cosmetic-indication date is claimed here. 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 |
|---|---|---|---|
| BLA021859 | BLA — approved | Primary | Open → |
Approved indication: not transcribed here — read it on BLA021859 → 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. A BLA is a biologics licence application. FDA approved the biologic product; approved, not cleared. The application can cover therapeutic indications as well as cosmetic ones, and Drugs@FDA does not publish a per-indication date.
Methodology →
Evidence
No modality is assigned to this product, so no literature or trial counts are shown.
Treatment areas
No treatment area could be derived: neither the modality's condition query nor the FDA product codes contained a term on the keyword list.
Sources
- openFDA query run for this producthttps://api.fda.gov/drug/drugsfda.json?search=openfda.brand_name:"HYLENEX"&limit=10
- FDA public record for BLA021859https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021859
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 →