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FDA Approval for TYMLOS issued to RADIUS HEALTH INC

$RDUS
Industrial Specialties
Consumer Discretionary
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New Drug Application (NDA): 208743
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
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