FDA Approval for NUZYRA issued to PARATEK PHARMS INC
$PRTK
Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 209816
Company: PARATEK PHARMS INC
Company: PARATEK PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NUZYRA | OMADACYCLINE TOSYLATE | EQ 150MG 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 |
|---|---|---|---|---|---|---|---|
| 10/02/2018 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209816_209817lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209816Orig1s000,209817Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/209816Orig1s000,209817Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/11/2021 | SUPPL-12 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209816Orig1s012; 209817Orig1s011ltr.pdf |
| 05/27/2021 | SUPPL-11 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
| 10/20/2020 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209816s009,209817s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209816Orig1s009, 209817Orig1s008ltr.pdf | |
| 09/02/2020 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/219816s008,209817s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209816Orig1s008, 209817Orig1s007ltr.pdf | |
| 06/13/2019 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209816s004,209817s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209816Orig1s004, 209817Orig1s003ltr.pdf | |
| 06/13/2019 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209816s003,209817s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209816Orig1s003, 209817Orig1s002ltr.pdf | |
| 06/13/2019 | SUPPL-2 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209816s002,209817s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209816Orig1s002, 209817Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/20/2020 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209816s009,209817s008lbl.pdf | |
| 09/02/2020 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/219816s008,209817s007lbl.pdf | |
| 06/13/2019 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209816s004,209817s003lbl.pdf | |
| 06/13/2019 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209816s003,209817s002lbl.pdf | |
| 06/13/2019 | SUPPL-2 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209816s002,209817s001lbl.pdf | |
| 06/13/2019 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209816s002,209817s001lbl.pdf | |
| 10/02/2018 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209816_209817lbl.pdf |