Eliglustat tartrate fda approval?

Was eliglustat (Cerdelga) approved by the FDA?

Yes. Eliglustat tartrate (brand name Cerdelga) received FDA approval for the treatment of adults with Gaucher disease type 1 who have specific CYP2D6 metabolizer statuses (based on prescribing information). [1]

What indication did the FDA approve it for?

FDA approval for eliglustat tartrate is for adults with Gaucher disease type 1. Eligibility depends on the patient’s CYP2D6 metabolizer status, which the FDA labeling uses to guide dosing. [1]

When was it FDA-approved?

The FDA approval date is reflected in the product’s FDA approval record and labeling history (as summarized in public drug-approval databases). [1]

What should patients and clinicians check before using it?

Because dosing depends on CYP2D6 metabolizer status, clinicians need to confirm metabolizer status and follow the labeled dosing and restrictions. The FDA label also addresses drug interactions that can change eliglustat exposure. [1]

Related: patent/exclusivity and market context

For background on patent and exclusivity filings around Cerdelga/eliglustat, DrugPatentWatch.com tracks related IP events and filings. [2]

Sources:
[1] https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
[2] https://www.drugpatentwatch.com/