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# FDA Accepts BioMarin Vosoritide NDA
- URL: https://www.fdaweb.com/fda-accepts-biomarin-vosoritide-nda/
- Published: 2020-11-05T12:00:00.000Z
- Updated: 2026-09-14T16:35:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148025

FDA has accepted a BioMarin NDA for vosoritide, an investigational, once-daily injection analog of C-type natriuretic peptide for children with achondroplasia, described as the most common form of disproportionate short stature in humans. The company says this is the first marketing application accepted by FDA for a treatment for achondroplasia in humans. The agency set 8/20/21 as the PDUFA action date for the NDA.

Vosoritide has already received orphan drug designation from FDA for treating children with achondroplasia.