For achondroplasia with open epiphyses. NDA 214938, held by Biomarin Pharm. Vosoritide.
As of Nov 13, 2026, NDA 214938 (Voxzogo), held by Biomarin Pharm, was first approved by FDA on Nov 19, 2021, with 2 approved supplements and 0 published complete response letters.
VOXZOGO is indicated to increase linear growth in pediatric patients with achondroplasia with open epiphyses. This indication is approved under accelerated approval based on an improvement in annualized growth velocity. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 20, 2023 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Nov 19, 2021 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Voxzogo0.4MG/VIAL · powder;subcutaneous | Vosoritide | RxReference drug |
| Voxzogo0.56MG/VIAL · powder;subcutaneous | Vosoritide | RxReference drug |
| Voxzogo1.2MG/VIAL · powder;subcutaneous | Vosoritide | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 4, 2024 | Supplement 4Labeling · Standard review | Approved | |
| Oct 20, 2023 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Nov 19, 2021 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
