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Drugs fda myoscint imciromab pentetate discontinued?

Short answer: Myoscint (imciromab pentetate) is discontinued and is no longer marketed in the United States. It was a radiopharmaceutical once used to image myocardial infarction, but it is not available today.

What it is about (very briefly):
- Imciromab pentetate is an indium-111–labeled murine monoclonal antibody fragment that binds to cardiac myosin to image damaged heart tissue.
- It was developed for detecting myocardial infarction and had FDA authorization in the past, but development was not ongoing and the product was withdrawn from the market.
- The main reasons for discontinuation cited in reviews and regulatory histories include limited diagnostic utility (sensitivity/specificity), lack of impact on patient management, and competition from other imaging modalities.

Current status and alternatives:
- There is no current FDA-approved analogue of Myoscint for routine clinical use in the U.S.
- For imaging myocardial infarction today, clinicians typically rely on other modalities such as ECG, cardiac MRI with late gadolinium enhancement, or nuclear imaging with technetium-99m–based SPECT agents (e.g., Tc-99m sestamibi or tetrofosmin).

If you’d like, I can summarize regulatory history sources (FDA labeling/history) or point to modern alternatives for myocardial infarct imaging. What specifically would you like to know?



Other Questions About Myoscint :

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