Vanda Pharma receives negative opinion from CHMP against the marketing authorization of Fanaptum :
The European Medicines Agency's Committee for Medicinal Product for Human Use (CHMP) has adopted a negative opinion recommending against the marketing authorization of Fanaptum (oral iloperidone tablets) for the treatment of schizophrenia in adult patients in the European Union.
- The CHMP was of the opinion that the benefits of Fanaptum did not outweigh its risks and recommended against marketing authorization.
- Vanda intends to appeal this opinion and request a re-examination by the CHMP.
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