NDA 213793

RHYTHM PHARMACEUTICALS INC

FDA Drug Application

Application #213793

Documents

• Letter: 2020-11-27
• Label: 2020-11-30
• Review: 2020-12-23
• Label: 2022-06-16
• Letter: 2022-06-17

Application Sponsors

NDA 213793

RHYTHM PHARMACEUTICALS INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;SUBCUTANEOUS

10MG/ML

2

IMCIVREE

SETMELANOTIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2020-11-25

PRIORITY

Submissions Property Types

ORIG

1

Null

6

TE Codes

001

Prescription

TBD

CDER Filings

RHYTHM PHARMACEUTICALS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213793
            [companyName] => RHYTHM PHARMACEUTICALS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"IMCIVREE","activeIngredients":"SETMELANOTIDE","strength":"10MG\/ML","dosageForm":"SOLUTION;SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"11\/25\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213793s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/25\/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\\\/213793s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/213793Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-11-25
        )

)