Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
Application Products
| 001 | CAPSULE;ORAL | EQ 0.25MG BASE | 1 | TALZENNA | TALAZOPARIB TOSYLATE |
| 002 | CAPSULE;ORAL | EQ 1MG BASE | 1 | TALZENNA | TALAZOPARIB TOSYLATE |
| 003 | CAPSULE;ORAL | EQ 0.5MG BASE | 1 | TALZENNA | TALAZOPARIB TOSYLATE |
| 004 | CAPSULE;ORAL | EQ 0.75MG BASE | 1 | TALZENNA | TALAZOPARIB TOSYLATE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2018-10-16 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 2 | AP | 2019-09-24 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 5 | AP | 2020-03-09 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 6 | AP | 2020-10-22 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 7 | AP | 2021-09-09 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2021-09-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2021-09-21 | N/A |
Submissions Property Types
| ORIG | 1 | Null | 6 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 5 | Null | 6 |
| SUPPL | 6 | Null | 6 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 8 | Null | 7 |
CDER Filings
PFIZER
cder:Array
(
[0] => Array
(
[ApplNo] => 211651
[companyName] => PFIZER
[docInserts] => ["",""]
[products] => [{"drugName":"TALZENNA","activeIngredients":"TALAZOPARIB TOSYLATE","strength":"EQ 0.25MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"TALZENNA","activeIngredients":"TALAZOPARIB TOSYLATE","strength":"EQ 1MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"03\/09\/2020","submission":"SUPPL-5","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/211651s005lbl.pdf\"}]","notes":""},{"actionDate":"09\/24\/2019","submission":"SUPPL-2","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/211651s002lbl.pdf\"}]","notes":""},{"actionDate":"10\/16\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/211651s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"10\/16\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/211651s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/211651Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/211651Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"03\/09\/2020","submission":"SUPPL-5","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/211651s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/211651Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"09\/24\/2019","submission":"SUPPL-2","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/211651s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211651Orig1s002ltr.pdf\"}]","notes":">"}]
[actionDate] => 2020-03-09
)
)