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Approved Risk Evaluation and Mitigation Strategies (REMS)

Natpara (parathyroid hormone)
BLA #125511
REMS last update: 09/14/2023



What is the purpose of the REMS?

The goal of the NATPARA REMS Program is to mitigate the potential risk of osteosarcoma associated with NATPARA by:

  1. Ensuring that prescribers are educated on the following:
    1. potential risk of osteosarcoma associated with the use of NATPARA
    2. appropriate patient selection
    3. safe-use conditions required for prescribing NATPARA
  2. Ensuring that NATPARA is dispensed only to patients informed about the potential risk of osteosarcoma associated with the use of NATPARA

What do participants need to know?

Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the application holder(s) REMS Website or the approved REMS materials for more information.

View application holder(s) REMS Website See Disclaimer page regarding links to external sites

What assessment is available to the REMS?

Assessment Plan
REMS assessment plan unavailable for posting at this time.

What updates have been made to the REMS?

Date Summary of change
09/14/2023 Updates to reflect change in application ownership
06/05/2020 Modified to change the timetable for submission of assessments from annually to every two years beginning with the REMS assessment for year six (72-month) and modified the REMS document to the new format to align with the recommendations in the October 2017 Draft Guidance: Format and Content of a REMS Document.
08/04/2017 Revised to change the application holder's name.
09/29/2016 Modified to add an online prescriber certification process.
01/23/2015 Approval of the REMS.

Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.

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