NDA 209296

HERON THERAPS INC

FDA Drug Application

Application #209296

Documents

• Letter: 2017-11-13
• Label: 2017-11-13
• Review: 2018-03-09
• Label: 2019-02-27
• Letter: 2019-02-28
• Letter: 2019-10-22
• Label: 2019-10-22
• Letter: 2022-03-15
• Label: 2022-04-20

Application Sponsors

NDA 209296

HERON THERAPS INC

Marketing Status

• Prescription: 001

Application Products

001

EMULSION;INTRAVENOUS

130MG/18ML (7.2MG/ML)

1

CINVANTI

APREPITANT

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2017-11-09	STANDARD
EFFICACY; Efficacy	SUPPL	3	AP	2019-02-26	STANDARD
EFFICACY; Efficacy	SUPPL	4	AP	2019-10-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2022-03-14	N/A

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	15
SUPPL	4	Null	6
SUPPL	8	Null	15

CDER Filings

HERON THERAPS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209296
            [companyName] => HERON THERAPS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CINVANTI","activeIngredients":"APREPITANT","strength":"130MG\/18ML (7.2MG\/ML)","dosageForm":"EMULSION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/14\/2022","submission":"SUPPL-8","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/209296Orig1s008lbl.pdf\"}]","notes":""},{"actionDate":"03\/14\/2022","submission":"SUPPL-8","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/209296Orig1s008lbl.pdf\"}]","notes":""},{"actionDate":"03\/14\/2022","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/209296Orig1s008lbl.pdf\"}]","notes":""},{"actionDate":"10\/21\/2019","submission":"SUPPL-4","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209296s004lbl.pdf\"}]","notes":""},{"actionDate":"02\/26\/2019","submission":"SUPPL-3","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209296s003lbl.pdf\"}]","notes":""},{"actionDate":"11\/09\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209296s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/09\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209296s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209296Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/209296Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"03\/14\/2022","submission":"SUPPL-8","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/209296Orig1s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/209296Orig1s008ltr.pdf\"}]","notes":">"},{"actionDate":"10\/21\/2019","submission":"SUPPL-4","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209296s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209296Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"02\/26\/2019","submission":"SUPPL-3","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209296s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209296Orig1s003ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2022-03-14
        )

)