Sarepta Therapeutics Temporarily Halts Elevidys Shipments in Compliance with FDA Requests

Sarepta Therapeutics Inc has voluntarily paused shipments of Elevidys in the United States. The decision responds to FDA requests, allowing the company to finalize the safety labeling process for the product. This move demonstrates Sarepta's commitment to meeting regulatory standards and ensuring patient safety.


Devdiscourse News Desk | Updated: 22-07-2025 05:16 IST | Created: 22-07-2025 05:16 IST
Sarepta Therapeutics Temporarily Halts Elevidys Shipments in Compliance with FDA Requests
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Sarepta Therapeutics Inc has announced a temporary suspension of Elevidys shipments across the United States. This decision comes as a proactive step to address requests from the U.S. Food and Drug Administration (FDA).

The pause will enable Sarepta to focus on completing the necessary steps for the safety labeling process of Elevidys, a critical aspect of ensuring compliance with regulatory standards.

The company's commitment to addressing these regulatory requirements underscores its dedication to patient safety and adherence to federal guidelines.

(With inputs from agencies.)

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