WEZLANA — FDA application BLA761285
Listed sponsor: AMGEN INC · AMGN company profile · exact_unique
Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.
FDA application facts
| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
|---|---|---|---|---|---|---|---|---|
| 001 | WEZLANA | USTEKINUMAB-AUUB | INJECTABLE | INTRAVENOUS, SUBCUTANEOUS | 45MG/0.5ML | Prescription | not listed | not listed |
| 002 | WEZLANA | USTEKINUMAB-AUUB | INJECTABLE | INTRAVENOUS, SUBCUTANEOUS | 90MG/ML | Prescription | not listed | not listed |
Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.
Orange Book patent and exclusivity listings
Patent/exclusivity listings: not applicable — the FDA Orange Book covers NDA and ANDA small-molecule applications, not BLA biologics.
Compound cross-links
- USTEKINUMAB · UNII FU77B4U5Z0 · no lmmol compound match
Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.
Related pages
Sponsor company · FDA-approved application index
Peer clusters: Large-cap biopharma
Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.
Regulatory listing data as published by FDA; not medical or investment advice.