Documents
Application Sponsors
| BLA 125274 | IPSEN BIOPHARM LTD | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE; INJECTION | 500 UNITS/VIAL | 0 | DYSPORT | abobotulinumtoxinA |
| 002 | INJECTABLE; INJECTION | 300 UNITS/VIAL | 0 | DYSPORT | abobotulinumtoxinA |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2009-04-29 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2010-09-27 | STANDARD |
| LABELING; Labeling | SUPPL | 52 | AP | 2012-05-22 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 102 | AP | 2015-07-15 | |
| EFFICACY; Efficacy | SUPPL | 105 | AP | 2016-07-29 | |
| EFFICACY; Efficacy | SUPPL | 107 | AP | 2016-12-09 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 109 | AP | 2017-06-14 | STANDARD |
| LABELING; Labeling | SUPPL | 112 | AP | 2018-11-05 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 115 | AP | 2019-09-25 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 118 | AP | 2020-07-08 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 123 | AP | 2023-01-12 | STANDARD |
Submissions Property Types
| ORIG | 1 | Orphan | 5 |
| SUPPL | 52 | Null | 7 |
| SUPPL | 102 | Null | 15 |
| SUPPL | 105 | Null | 7 |
| SUPPL | 107 | Null | 7 |
| SUPPL | 109 | Null | 6 |
| SUPPL | 112 | Null | 15 |
| SUPPL | 115 | Null | 7 |
| SUPPL | 118 | Null | 15 |
| SUPPL | 123 | Null | 6 |
CDER Filings
IPSEN BIOPHARM LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 125274
[companyName] => IPSEN BIOPHARM LTD
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/125274s115lbl.pdf#page=31"]
[products] => [{"drugName":"DYSPORT","activeIngredients":"abobotulinumtoxinA","strength":"500 UNITS\/VIAL","dosageForm":"INJECTABLE; INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"DYSPORT","activeIngredients":"abobotulinumtoxinA","strength":"300 UNITS\/VIAL","dosageForm":"INJECTABLE; INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"09\/25\/2019","submission":"SUPPL-115","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125274s115lbl.pdf\"}]","notes":""},{"actionDate":"11\/05\/2018","submission":"SUPPL-112","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125274s112lbl.pdf\"}]","notes":""},{"actionDate":"06\/14\/2017","submission":"SUPPL-109","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125274s109lbl.pdf\"}]","notes":""},{"actionDate":"12\/09\/2016","submission":"SUPPL-107","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125274s107lbl.pdf\"}]","notes":""},{"actionDate":"07\/29\/2016","submission":"SUPPL-105","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125274s105lbl.pdf\"}]","notes":""},{"actionDate":"05\/22\/2012","submission":"SUPPL-52","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125274s0052lbl.pdf\"}]","notes":""},{"actionDate":"04\/29\/2009","submission":"SUPPL-1","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/125274s0000s0001lbl.pdf\"}]","notes":""},{"actionDate":"04\/29\/2009","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/125274s0000s0001lbl.pdf\"}]","notes":""}]
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[supplements] => [{"actionDate":"07\/08\/2020","submission":"SUPPL-118","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/25\/2019","submission":"SUPPL-115","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125274s115lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/125274Orig1s115ltr.pdf\"}]","notes":">"},{"actionDate":"11\/05\/2018","submission":"SUPPL-112","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125274s112lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/125274Orig1s112ltr.pdf\"}]","notes":">"},{"actionDate":"06\/14\/2017","submission":"SUPPL-109","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125274s109lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125274Orig1s109ltr.pdf\"}]","notes":">"},{"actionDate":"12\/09\/2016","submission":"SUPPL-107","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125274s107lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/125274Orig1s107ltr.pdf\"}]","notes":">"},{"actionDate":"07\/29\/2016","submission":"SUPPL-105","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125274s105lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/125274Orig1s105ltr.pdf\"}]","notes":">"},{"actionDate":"07\/15\/2015","submission":"SUPPL-102","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/125274Orig1s102ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"05\/22\/2012","submission":"SUPPL-52","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125274s0052lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/125274s0052ltr.pdf\"}]","notes":">"},{"actionDate":"09\/27\/2010","submission":"SUPPL-14","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/29\/2009","submission":"SUPPL-1","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/125274s0000s0001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2009\\\/125274s001_dysport_toc.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2009\\\/125274Orig1s001SumR.pdf\"}]","notes":">"}]
[actionDate] => 2020-07-08
)
)