FDA withdraws authorization of Istodax in PTCL indication

The Food and Drug Administration has announced that it is withdrawing approval of the peripheral T-cell lymphoma (PTCL) indication for Istodax (romidepsin) for Injection, approved under New Drug Application (NDA) 022393, owned by Celgene, which was acquired in 2019 by Bristol Myers Squibb (NYSE: BMY) for $74 billion.

The FDA also announced the withdrawal of approval for the same indication for romidepsin injection, approved under NDA 208574, owned by…

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