Treats Gaucher disease type 1 (GD1). NDA 205494, held by Genzyme Corp. Eliglustat Tartrate.
As of Nov 15, 2026, NDA 205494 (Cerdelga), held by Genzyme Corp, was first approved by FDA on Aug 19, 2014, with 3 approved supplements and 0 published complete response letters.
CERDELGA is indicated for the long-term treatment of adult patients with Gaucher disease type 1 (GD1) who are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs) as detected by an FDA-cleared test.
| Aug 29, 2018 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Aug 19, 2014 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| CerdelgaEQ 84MG BASE · capsule;oral | Eliglustat Tartrate | RxReference drug |
| Aug 29, 2018 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| May 11, 2015 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Nov 5, 2014 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Aug 19, 2014 | Original applicationNew molecular entity · Priority 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
