NDA 211723

EPIZYME INC

FDA Drug Application

Application #211723

Documents

• Letter: 2020-01-24
• Label: 2020-01-24
• Medication Guide: 2020-01-24
• Review: 2020-02-19

Application Sponsors

NDA 211723

EPIZYME INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 200MG BASE

1

TAZVERIK

TAZEMETOSTAT HYDROBROMIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2020-01-23

PRIORITY

Submissions Property Types

ORIG

1

Null

6

CDER Filings

EPIZYME INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211723
            [companyName] => EPIZYME INC
            [docInserts] => ["Medication Guide","http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/211723s000lbl.pdf#page=14"]
            [products] => [{"drugName":"TAZVERIK","activeIngredients":"TAZEMETOSTAT HYDROBROMIDE","strength":"EQ 200MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"01\/23\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/211723s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/23\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/211723s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/211723Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2020\\\/211723Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-01-23
        )

)