FDA Approval for TYMLOS issued to RADIUS HEALTH INC
$RDUS
Industrial Specialties
Consumer Discretionary
New Drug Application (NDA): 208743
Company: RADIUS HEALTH INC
Company: RADIUS HEALTH INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TYMLOS | ABALOPARATIDE | 3.12MG/1.56ML (2MG/ML) | SOLUTION;SUBCUTANEOUS | 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 |
|---|---|---|---|---|---|---|---|
| 04/28/2017 | ORIG-1 | Approval | Type 1 - New Molecular Entity and Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208743lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208743Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208743Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208743Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/19/2022 | SUPPL-13 | Efficacy-New Indication |
Label is not available on this site. |
||
| 12/22/2021 | SUPPL-10 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208743s010lbl.pdf | |
| 09/20/2021 | SUPPL-9 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208743s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208743Orig1s009ltr.pdf | |
| 10/23/2020 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208743s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208743Orig1s007ltr.pdf | |
| 06/20/2018 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208743s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208743Orig1s004ltr.pdf | |
| 10/17/2018 | SUPPL-3 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208743s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208743Orig1s003ltr.pdf | |
| 02/05/2018 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208743s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208743Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/22/2021 | SUPPL-10 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208743s010lbl.pdf | |
| 09/20/2021 | SUPPL-9 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208743s009lbl.pdf | |
| 10/23/2020 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208743s007lbl.pdf | |
| 10/17/2018 | SUPPL-3 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208743s003lbl.pdf | |
| 06/20/2018 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208743s004lbl.pdf | |
| 02/05/2018 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208743s001lbl.pdf | |
| 04/28/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208743lbl.pdf |