U.S. FDA Approves Janssen’s Six-Month Long-Acting Injectable Antipsychotic, Invega Hafyera

The U.S. Food and Drug Administration (FDA) approved a long-acting injected (LAI) antipsychotic that lasts for six months, Invega Hafyera (paliperidone palmitate, which was developed by Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen). Invega Hafyera is administered by a health care professional in the upper buttocks area every six months. The LAI is intended for people already taking the antipsychotics Invega Sustenna or Invega Trinza. Invega Sustenna is a one-month LAI, and Invega Trinza lasts for three months.

The approval was based on the outcomes of a phase 3 non-inferiority global study which showed over . . .