FDA Approved: SIRTURO — Supplemental Application (Janssen Products, LP)

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Summary

FDA approved Janssen's supplemental application for SIRTURO (bedaquiline fumarate), enabling changes to the product labeling based on new data.

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Diseases / indications

• Multidrug-resistant Tuberculosis

Drugs mentioned

• SIRTURO (bedaquiline fumarate)

Snippet

SUPPL AP for SIRTURO (BEDAQUILINE FUMARATE)