2023-05-12 14:42:30 ET
- The US FDA has granted approval to Astellas Pharma's ( OTCPK:ALPMF )( OTCPK:ALPMY ) Veozah (fezolinetant) for hot flashes associated with menopause.
- The agency noted that the drug is the first neurokinin 3 (NK3) receptor antagonist approved for the condition.
- The efficacy of Veozah was demonstrated in two phase 3 trials.
- The labeling for the drug includes a warning on risk of liver injury.
- In February, the FDA extended the review period for Veozah by three months.
For further details see:
Astellas wins FDA approval of hot flashes drug Veozah