Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 25MG | 1 | LORBRENA | LORLATINIB |
| 002 | TABLET;ORAL | 100MG | 1 | LORBRENA | LORLATINIB |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2018-11-02 | PRIORITY |
| LABELING; Labeling | SUPPL | 2 | AP | 2021-01-22 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2021-02-26 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 4 | AP | 2021-03-03 | PRIORITY |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 3 | Null | 6 |
| SUPPL | 4 | Null | 30 |
CDER Filings
PFIZER
cder:Array
(
[0] => Array
(
[ApplNo] => 210868
[companyName] => PFIZER
[docInserts] => ["",""]
[products] => [{"drugName":"LORBRENA","activeIngredients":"LORLATINIB","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"LORBRENA","activeIngredients":"LORLATINIB","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"05\/29\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/210868s001lbl.pdf\"}]","notes":""},{"actionDate":"11\/02\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210868s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"11\/02\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210868s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210868Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/210868Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"05\/29\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/210868s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/210868Orig1s001ltr.pdf\"}]","notes":">"}]
[actionDate] => 2020-05-29
)
)