FDA pulls 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, held by Celgene, which was acquired in 2019 by Bristol Myers Squibb (NYSE: BMY) for $74 billion.

The FDA also announced the withdrawal of approval of the same indication for romidepsin injection, approved under NDA 208574, held by Israeli generics giant Teva Pharmaceutical Industries’ (NYSE: TEVA) US subsidiary.

Celgene and Teva have voluntarily requested that that FDA withdraw approval of this indication and have waived their opportunity for a hearing, the agency said.