Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | TABLET;ORAL | 10MG | 1 | OTEZLA | APREMILAST |
| 002 | TABLET;ORAL | 20MG | 1 | OTEZLA | APREMILAST |
| 003 | TABLET;ORAL | 30MG | 1 | OTEZLA | APREMILAST |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2014-03-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2014-07-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2014-09-19 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2015-04-27 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2015-12-21 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2017-06-29 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 7 | AP | 2019-07-19 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 2020-04-10 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 11 | AP | 2021-12-20 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 6 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 7 | Orphan | 5 |
| SUPPL | 8 | Null | 15 |
| SUPPL | 11 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
AMGEN INC
cder:Array
(
[0] => Array
(
[ApplNo] => 205437
[companyName] => AMGEN INC
[docInserts] => ["",""]
[products] => [{"drugName":"OTEZLA","activeIngredients":"APREMILAST","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"OTEZLA","activeIngredients":"APREMILAST","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"OTEZLA","activeIngredients":"APREMILAST","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"04\/10\/2020","submission":"SUPPL-8","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/205437Orig1s008lbl.pdf\"}]","notes":""},{"actionDate":"07\/19\/2019","submission":"SUPPL-7","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/205437Orig1s007lbl.pdf\"}]","notes":""},{"actionDate":"06\/29\/2017","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205437s006lbl.pdf\"}]","notes":""},{"actionDate":"12\/21\/2015","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205437s005lbl.pdf\"}]","notes":""},{"actionDate":"03\/21\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/205437s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"03\/21\/2014","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\\\/2014\\\/205437s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/205437Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/205437Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"04\/10\/2020","submission":"SUPPL-8","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/205437Orig1s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/205437Orig1s008ltr.pdf\"}]","notes":">"},{"actionDate":"07\/19\/2019","submission":"SUPPL-7","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/205437Orig1s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/205437Orig1s007ltr.pdf\"}]","notes":">"},{"actionDate":"06\/29\/2017","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205437s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/205437Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"12\/21\/2015","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205437s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/205437Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"04\/27\/2015","submission":"SUPPL-4","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/19\/2014","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/28\/2014","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/22\/2014","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-04-10
)
)