FDA Approval for RUBRACA issued to CLOVIS ONCOLOGY INC
$CLVS
Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 209115
Company: CLOVIS ONCOLOGY INC
Company: CLOVIS ONCOLOGY INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RUBRACA | RUCAPARIB CAMSYLATE | EQ 200MG BASE | TABLET;ORAL | Prescription | None | Yes | Yes |
| RUBRACA | RUCAPARIB CAMSYLATE | EQ 300MG BASE | TABLET;ORAL | Prescription | None | Yes | Yes |
| RUBRACA | RUCAPARIB CAMSYLATE | EQ 250MG BASE | TABLET;ORAL | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/19/2016 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/209115s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/209115Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/209115Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/10/2022 | SUPPL-11 |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209115s011lbl.pdf | ||
| 09/30/2021 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209115s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209115Orig1s009ltr.pdf | |
| 10/08/2020 | SUPPL-8 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209115s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209115Orig1s008ltr.pdf | |
| 05/15/2020 | SUPPL-4 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209115s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209115Orig1s004ltr.pdf | |
| 04/06/2018 | SUPPL-3 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209115s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209115Orig1s003ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/10/2022 | SUPPL-11 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209115s011lbl.pdf | |
| 09/30/2021 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209115s009lbl.pdf | |
| 10/08/2020 | SUPPL-8 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209115s008lbl.pdf | |
| 05/15/2020 | SUPPL-4 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209115s004lbl.pdf | |
| 04/06/2018 | SUPPL-3 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209115s003lbl.pdf | |
| 12/19/2016 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/209115s000lbl.pdf |