NDA 202799

TAKEDA PHARMS USA

FDA Drug Application

Application #202799

Documents

• Letter: 2012-12-06
• Review: 2012-05-03
• Medication Guide: 2012-03-27
• Letter: 2012-03-27
• Label: 2012-03-27
• Label: 2012-12-05
• Other: 2012-03-28

Application Sponsors

NDA 202799

TAKEDA PHARMS USA

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004
• Discontinued: 005
• Discontinued: 006
• Discontinued: 007
• Discontinued: 008

Application Products

001	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	EQ 1MG BASE/0.5ML (EQ 1MG BASE/0.5ML)	0	OMONTYS PRESERVATIVE FREE	PEGINESATIDE ACETATE
002	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	EQ 2MG BASE/0.5ML (EQ 2MG BASE/0.5ML)	0	OMONTYS PRESERVATIVE FREE	PEGINESATIDE ACETATE
003	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	0	OMONTYS PRESERVATIVE FREE	PEGINESATIDE ACETATE
004	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	EQ 4MG BASE/0.5ML (EQ 4MG BASE/0.5ML)	0	OMONTYS PRESERVATIVE FREE	PEGINESATIDE ACETATE
005	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	EQ 5MG BASE/0.5ML (EQ 5MG BASE/0.5ML)	0	OMONTYS PRESERVATIVE FREE	PEGINESATIDE ACETATE
006	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	EQ 6MG BASE/0.5ML (EQ 6MG BASE/0.5ML)	0	OMONTYS PRESERVATIVE FREE	PEGINESATIDE ACETATE
007	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	0	OMONTYS	PEGINESATIDE ACETATE
008	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	0	OMONTYS	PEGINESATIDE ACETATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2012-03-27

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

TAKEDA PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202799
            [companyName] => TAKEDA PHARMS USA
            [docInserts] => ["Medication Guide","http:\/\/www.fda.gov\/downloads\/Drugs\/DrugSafety\/UCM297877.pdf"]
            [products] => [{"drugName":"OMONTYS","activeIngredients":"PEGINESATIDE ACETATE","strength":"EQ 10MG BASE\/ML (EQ 10MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS, SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OMONTYS","activeIngredients":"PEGINESATIDE ACETATE","strength":"EQ 20MG BASE\/2ML (EQ 10MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS, SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OMONTYS PRESERVATIVE FREE","activeIngredients":"PEGINESATIDE ACETATE","strength":"EQ 1MG BASE\/0.5ML (EQ 1MG BASE\/0.5ML)","dosageForm":"SOLUTION;INTRAVENOUS, SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OMONTYS PRESERVATIVE FREE","activeIngredients":"PEGINESATIDE ACETATE","strength":"EQ 2MG BASE\/0.5ML (EQ 2MG BASE\/0.5ML)","dosageForm":"SOLUTION;INTRAVENOUS, SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OMONTYS PRESERVATIVE FREE","activeIngredients":"PEGINESATIDE ACETATE","strength":"EQ 3MG BASE\/0.5ML (EQ 3MG BASE\/0.5ML)","dosageForm":"SOLUTION;INTRAVENOUS, SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OMONTYS PRESERVATIVE FREE","activeIngredients":"PEGINESATIDE ACETATE","strength":"EQ 4MG BASE\/0.5ML (EQ 4MG BASE\/0.5ML)","dosageForm":"SOLUTION;INTRAVENOUS, SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OMONTYS PRESERVATIVE FREE","activeIngredients":"PEGINESATIDE ACETATE","strength":"EQ 5MG BASE\/0.5ML (EQ 5MG BASE\/0.5ML)","dosageForm":"SOLUTION;INTRAVENOUS, SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OMONTYS PRESERVATIVE FREE","activeIngredients":"PEGINESATIDE ACETATE","strength":"EQ 6MG BASE\/0.5ML (EQ 6MG BASE\/0.5ML)","dosageForm":"SOLUTION;INTRAVENOUS, SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"12\/04\/2012","submission":"SUPPL-1","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202799s001lbl.pdf\"}]","notes":""},{"actionDate":"12\/04\/2012","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202799s001lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2012","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202799s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/27\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202799s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/202799Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2012\\\/202799_Omontys_Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"12\/04\/2012","submission":"SUPPL-1","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202799s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/202799Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2012-12-04
        )

)