RADIUS HEALTH INC FDA Approval NDA 208743

NDA 208743

RADIUS HEALTH INC

FDA Drug Application

Application #208743

Documents

Label2017-04-28
Letter2017-04-28
Medication Guide2017-04-28
Review2017-06-08
Summary Review2017-06-08
Label2018-02-05
Letter2018-02-09
Letter2018-06-27
Label2018-07-04
Label2018-10-18
Letter2018-10-23
Letter2020-10-27
Label2020-10-27
Medication Guide2020-10-27
Label2021-09-21
Medication Guide2021-09-21
Letter2021-09-21
Letter2021-10-29
Label2021-12-23
Label2022-12-21
Medication Guide2022-12-21

Application Sponsors

NDA 208743RADIUS HEALTH INC

Marketing Status

Prescription001

Application Products

001SOLUTION;SUBCUTANEOUS3.12MG/1.56ML (2MG/ML)1TYMLOSABALOPARATIDE

FDA Submissions

TYPE 1/4; Type 1 - New Molecular Entity and Type 4 - New CombinationORIG1AP2017-04-28STANDARD
EFFICACY; EfficacySUPPL3AP2018-10-17STANDARD
LABELING; LabelingSUPPL4AP2018-06-20STANDARD
LABELING; LabelingSUPPL7AP2020-10-23STANDARD
EFFICACY; EfficacySUPPL9AP2021-09-20STANDARD
EFFICACY; EfficacySUPPL10TA2021-10-28STANDARD
EFFICACY; EfficacySUPPL13AP2022-12-19STANDARD

Submissions Property Types

ORIG1Null40
SUPPL3Null7
SUPPL4Null15
SUPPL7Null15
SUPPL9Null7
SUPPL10Null6
SUPPL13Null6

CDER Filings

RADIUS HEALTH INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208743
            [companyName] => RADIUS HEALTH INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/208743s007lbl.pdf#page=18"]
            [products] => [{"drugName":"TYMLOS","activeIngredients":"ABALOPARATIDE","strength":"3.12MG\/1.56ML (2MG\/ML)","dosageForm":"SOLUTION;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/23\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208743s007lbl.pdf\"}]","notes":""},{"actionDate":"10\/17\/2018","submission":"SUPPL-3","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208743s003lbl.pdf\"}]","notes":""},{"actionDate":"06\/20\/2018","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208743s004lbl.pdf\"}]","notes":""},{"actionDate":"02\/05\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208743s001lbl.pdf\"}]","notes":""},{"actionDate":"04\/28\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208743lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/28\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity and Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208743lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208743Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/208743Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/208743Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"10\/23\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208743s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/208743Orig1s007ltr.pdf\"}]","notes":">"},{"actionDate":"06\/20\/2018","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208743s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/208743Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"10\/17\/2018","submission":"SUPPL-3","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208743s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/208743Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"02\/05\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208743s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/208743Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-10-23
        )

)
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