BLA 761177

ACENDIS PHARMA ENDOCRINOLOGY DIV A/S

FDA Drug Application

Application #761177

Documents

• Label: 2021-08-25
• Letter: 2021-08-27
• Review: 2021-09-24
• Letter: 2022-10-21
• Label: 2022-10-24

Application Sponsors

BLA 761177

ACENDIS PHARMA ENDOCRINOLOGY DIV A/S

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006
• Prescription: 007
• Prescription: 008
• Prescription: 009

Application Products

001	INJECTABLE;INJECTION	3MG	0	SKYTROFA	LONAPEGSOMATROPIN-TCGD
002	INJECTABLE;INJECTION	3.6MG	0	SKYTROFA	LONAPEGSOMATROPIN-TCGD
003	INJECTABLE;INJECTION	4.3MG	0	SKYTROFA	LONAPEGSOMATROPIN-TCGD
004	INJECTABLE;INJECTION	5.2MG	0	SKYTROFA	LONAPEGSOMATROPIN-TCGD
005	INJECTABLE;INJECTION	6.3MG	0	SKYTROFA	LONAPEGSOMATROPIN-TCGD
006	INJECTABLE;INJECTION	7.6MG	0	SKYTROFA	LONAPEGSOMATROPIN-TCGD
007	INJECTABLE;INJECTION	9.1MG	0	SKYTROFA	LONAPEGSOMATROPIN-TCGD
008	INJECTABLE;INJECTION	11MG	0	SKYTROFA	LONAPEGSOMATROPIN-TCGD
009	INJECTABLE;INJECTION	13.3MG	0	SKYTROFA	LONAPEGSOMATROPIN-TCGD

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2021-08-25

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

ACENDIS PHARMA ENDOCRINOLOGY DIV A/S

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(
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        (
            [ApplNo] => 761177
            [companyName] => ACENDIS PHARMA ENDOCRINOLOGY DIV A/S
            [docInserts] => ["",""]
            [products] => [{"drugName":"SKYTROFA","activeIngredients":"LONAPEGSOMATROPIN-TCGD","strength":"3MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"SKYTROFA","activeIngredients":"LONAPEGSOMATROPIN-TCGD","strength":"3.6MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"SKYTROFA","activeIngredients":"LONAPEGSOMATROPIN-TCGD","strength":"4.3MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"SKYTROFA","activeIngredients":"LONAPEGSOMATROPIN-TCGD","strength":"5.2MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"SKYTROFA","activeIngredients":"LONAPEGSOMATROPIN-TCGD","strength":"6.3MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"SKYTROFA","activeIngredients":"LONAPEGSOMATROPIN-TCGD","strength":"7.6MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"SKYTROFA","activeIngredients":"LONAPEGSOMATROPIN-TCGD","strength":"9.1MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"SKYTROFA","activeIngredients":"LONAPEGSOMATROPIN-TCGD","strength":"11MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"SKYTROFA","activeIngredients":"LONAPEGSOMATROPIN-TCGD","strength":"13.3MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"08\/25\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/761177lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/25\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/761177lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/761177Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-08-25
        )

)