VIVUS INC FDA Approval BLA 022523

BLA 022523

VIVUS INC

FDA Drug Application

Application #022523

Documents

Other2020-03-23
Other2020-03-23
Other2020-03-23
Other2020-03-23
Other2020-03-23
Other2020-03-23
Other2020-03-23
Other2020-03-23
Other2020-03-23
Other2020-03-23
Other2020-03-23
Other2020-03-23
Other2020-03-23
Letter2020-03-23
Label2020-03-26
Medication Guide2020-03-26
Pediatric Medical Review1900-01-01
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01
Other2020-03-23
Letter2021-11-03
Label2021-11-03
Label2021-12-15

Application Sponsors

BLA 022523VIVUS INC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006

Application Products

001CAPSULE, DELAYED RELEASE;ORAL24,600USP UNITS; 4,200USP UNITS; 14,200USP UNITS0PANCREAZEPANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
002CAPSULE, DELAYED RELEASE;ORAL61,500USP UNITS; 10,500USP UNITS; 35,500USP UNITS0PANCREAZEPANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
003CAPSULE, DELAYED RELEASE;ORAL98,400USP UNITS; 16,800USP UNITS; 56,800USP UNITS0PANCREAZEPANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
004CAPSULE, DELAYED RELEASE;ORAL83,900USP UNITS; 21,000USP UNITS; 54,700USP UNITS0PANCREAZEPANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
005CAPSULE, DELAYED RELEASE;ORAL10,850USP UNITS;2,600USP UNITS;6,200USP UNITS0PANCREAZEPANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
006CAPSULE, DELAYED RELEASE;ORAL15,200USP UNITS; 2,600USP UNITS; 8,800USP UNITS0PANCREAZEPANCRELIPASE (AMYLASE;LIPASE;PROTEASE)

FDA Submissions

TYPE 7; Type 7 - Drug Already Marketed without Approved NDAORIG1AP2010-04-12STANDARD
REMS; REMSSUPPL2AP2011-06-20N/A
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2012-12-07STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP2014-03-07STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP2014-05-27STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL6AP2014-06-23STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL7AP2016-05-16STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2015-03-03STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL9AP2015-03-30STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL10AP2016-08-04STANDARD
LABELING; LabelingSUPPL13AP2020-03-20STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2020-01-28N/A
LABELING; LabelingSUPPL16AP2021-11-02STANDARD

Submissions Property Types

ORIG1Null2
SUPPL2Null31
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0
SUPPL8Null0
SUPPL9Null0
SUPPL13Null15

CDER Filings

VIVUS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22523
            [companyName] => VIVUS INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/022523s013lbl.pdf#page=16"]
            [products] => [{"drugName":"PANCREAZE","activeIngredients":"PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)","strength":"24,600USP UNITS; 4,200USP UNITS; 14,200USP UNITS","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"PANCREAZE","activeIngredients":"PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)","strength":"61,500USP UNITS; 10,500USP UNITS; 35,500USP UNITS","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"PANCREAZE","activeIngredients":"PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)","strength":"98,400USP UNITS; 16,800USP UNITS; 56,800USP UNITS","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"PANCREAZE","activeIngredients":"PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)","strength":"83,900USP UNITS; 21,000USP UNITS; 54,700USP UNITS","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"PANCREAZE","activeIngredients":"PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)","strength":"10,850USP UNITS;2,600USP UNITS;6,200USP UNITS","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"03\/20\/2020","submission":"SUPPL-13","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022523s013lbl.pdf\"}]","notes":""},{"actionDate":"03\/20\/2020","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022523s013lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"PANCREAZE","submission":"PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)","actionType":"24,600USP UNITS; 4,200USP UNITS; 14,200USP UNITS","submissionClassification":"CAPSULE, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PANCREAZE","submission":"PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)","actionType":"61,500USP UNITS; 10,500USP UNITS; 35,500USP UNITS","submissionClassification":"CAPSULE, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PANCREAZE","submission":"PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)","actionType":"98,400USP UNITS; 16,800USP UNITS; 56,800USP UNITS","submissionClassification":"CAPSULE, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PANCREAZE","submission":"PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)","actionType":"83,900USP UNITS; 21,000USP UNITS; 54,700USP UNITS","submissionClassification":"CAPSULE, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PANCREAZE","submission":"PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)","actionType":"10,850USP UNITS;2,600USP UNITS;6,200USP UNITS","submissionClassification":"CAPSULE, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2020-03-20
        )

)
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