GENENTECH FDA Approval BLA 103976

BLA 103976

GENENTECH

FDA Drug Application

Application #103976

Documents

Letter2004-03-30
Letter2014-10-01
Letter2015-12-08
Letter2016-07-07
Label2004-03-30
Label2006-04-14
Label2007-07-02
Label2014-03-25
Label2016-07-08
Letter2006-04-14
Letter2010-02-05
Letter2011-01-10
Letter2012-01-05
Letter2014-03-25
Label2014-09-30
Label2015-12-08
Other Important Information from FDA2004-03-30
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01
Letter2018-10-01
Label2018-10-03
Letter2019-05-02
Label2019-05-02
Medication Guide2019-05-02
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01
Pediatric Other1900-01-01
Pediatric Medical Review1900-01-01
Label2020-12-01
Medication Guide2020-12-01
Letter2020-12-02
Review2021-01-07
Review2021-01-07
Label2021-04-12
Medication Guide2021-04-12
Letter2021-04-13
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01
Pediatric Medical Review1900-01-01
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01
Medication Guide2022-03-18
Label2022-03-18
Label2022-03-18

Application Sponsors

BLA 103976GENENTECH

Marketing Status

Prescription001

Application Products

001VIAL150MG/VIAL0XOLAIROMALIZUMAB

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2003-06-20STANDARD
S; SupplementSUPPL5087AP2006-04-07
LABELING; LabelingSUPPL5102AP2007-07-02STANDARD
LABELING; LabelingSUPPL5154AP2009-07-24STANDARD
EFFICACY; EfficacySUPPL5161AP2014-09-26STANDARD
LABELING; LabelingSUPPL5165AP2010-07-30STANDARD
EFFICACY; EfficacySUPPL5166AP2010-01-04STANDARD
LABELING; LabelingSUPPL5180AP2010-12-21STANDARD
LABELING; LabelingSUPPL5191AP2011-12-22STANDARD
EFFICACY; EfficacySUPPL5211AP2014-03-21STANDARD
LABELING; LabelingSUPPL5224AP2015-12-03STANDARD
EFFICACY; EfficacySUPPL5225AP2016-07-06STANDARD
EFFICACY; EfficacySUPPL5231AP2018-09-28PRIORITY
LABELING; LabelingSUPPL5234AP2019-05-01STANDARD
EFFICACY; EfficacySUPPL5235AP2020-11-30STANDARD
EFFICACY; EfficacySUPPL5238AP2021-04-09STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5239AP2021-07-22STANDARD

Submissions Property Types

SUPPL5087Null0
SUPPL5154Null7
SUPPL5161Null7
SUPPL5180Null7
SUPPL5191Null7
SUPPL5224Null6
SUPPL5225Null7
SUPPL5231Null6
SUPPL5234Null15
SUPPL5235Null6
SUPPL5238Null7

CDER Filings

GENENTECH
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 103976
            [companyName] => GENENTECH
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/103976s5234lbl.pdf#page=33"]
            [products] => [{"drugName":"XOLAIR","activeIngredients":"OMALIZUMAB","strength":"150MG\/VIAL","dosageForm":"VIAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"05\/01\/2019","submission":"SUPPL-5234","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/103976s5234lbl.pdf\"}]","notes":""},{"actionDate":"09\/28\/2018","submission":"SUPPL-5231","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/103976s5231lbl.pdf\"}]","notes":""},{"actionDate":"07\/06\/2016","submission":"SUPPL-5225","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/103976s5225lbl.pdf\"}]","notes":""},{"actionDate":"12\/03\/2015","submission":"SUPPL-5224","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/103976s5224lbl.pdf\"}]","notes":""},{"actionDate":"09\/26\/2014","submission":"SUPPL-5161","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/103976s5161lbl.pdf\"}]","notes":""},{"actionDate":"03\/21\/2014","submission":"SUPPL-5211","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/103976s5211lbl.pdf\"}]","notes":""},{"actionDate":"07\/02\/2007","submission":"SUPPL-5102","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/103976s5102lbl.pdf\"}]","notes":""},{"actionDate":"04\/07\/2006","submission":"SUPPL-5087","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/103976s5097lbl.pdf\"}]","notes":""},{"actionDate":"06\/20\/2003","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/omalgen062003LB.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/20\/2003","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/omalgen062003LB.pdf\"},{\"name\":\"Letter\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2003\\\/omalgen062003L.htm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"05\/01\/2019","submission":"SUPPL-5234","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/103976s5234lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/103976Orig1s5234ltr.pdf\"}]","notes":">"},{"actionDate":"09\/28\/2018","submission":"SUPPL-5231","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/103976s5231lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/103976Orig1s5231ltr.pdf\"}]","notes":">"},{"actionDate":"07\/06\/2016","submission":"SUPPL-5225","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/103976s5225lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/103976Orig1s5225ltr.pdf\"}]","notes":">"},{"actionDate":"12\/03\/2015","submission":"SUPPL-5224","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/103976s5224lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/103976Orig1s5224ltr.pdf\"}]","notes":">"},{"actionDate":"03\/21\/2014","submission":"SUPPL-5211","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/103976s5211lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/103976Orig1s5211ltr.pdf\"}]","notes":">"},{"actionDate":"12\/22\/2011","submission":"SUPPL-5191","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/103976s5191ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"12\/21\/2010","submission":"SUPPL-5180","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2010\\\/103976s5180ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"01\/04\/2010","submission":"SUPPL-5166","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2010\\\/103976s5166ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"07\/30\/2010","submission":"SUPPL-5165","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/26\/2014","submission":"SUPPL-5161","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/103976s5161lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/103976Orig1s5161ltr.pdf\"}]","notes":">"},{"actionDate":"07\/24\/2009","submission":"SUPPL-5154","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/02\/2007","submission":"SUPPL-5102","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/103976s5102lbl.pdf\"}]","notes":">"},{"actionDate":"04\/07\/2006","submission":"SUPPL-5087","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/103976s5097lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2006\\\/103976s5097ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2019-05-01
        )

)
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