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Healthtrust
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Generated: April 23, 2018

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Details for New Drug Application (NDA): 205494

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NDA 205494 describes CERDELGA, which is a drug marketed by Genzyme Corp and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the CERDELGA profile page.

The generic ingredient in CERDELGA is eliglustat tartrate. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the eliglustat tartrate profile page.
Summary for 205494
Tradename:CERDELGA
Applicant:Genzyme Corp
Ingredient:eliglustat tartrate
Patents:3
Pharmacology for NDA: 205494
Mechanism of ActionGlucosylceramide Synthase Inhibitors
P-Glycoprotein Inhibitors
Cytochrome P450 2D6 Inhibitors
Suppliers and Packaging for NDA: 205494
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CERDELGA eliglustat tartrate CAPSULE;ORAL 205494 NDA Genzyme Corporation 58468-0220 N 58468-0220-2
CERDELGA eliglustat tartrate CAPSULE;ORAL 205494 NDA Genzyme Corporation 58468-0220 N 58468-0220-1

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 84MG BASE
Approval Date:Aug 19, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 19, 2021
Regulatory Exclusivity Use:LONG-TERM TREATMENT OF ADULT PATIENTS WITH GAUCHER DISEASE TYPE 1 WHO ARE CYP2D6 EXTENSIVE METABOLIZERS (EMS), INTERMEDIATE METABOLIZERS (IMS), OR POOR METABOLIZERS (PMS) AS DETECTED BY AN FDA-CLEARED TEST.
Regulatory Exclusivity Expiration:Aug 19, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Try a Free TrialPatent Expiration:Apr 29, 2022Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF GAUCHER DISEASE TYPE 1

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