SUMMARY

• A new formulation of DARZALEX single-dose vials (100 mg/5 mL [NDC 57894-505-05] and 400 mg/20 mL [NDC 57894-505-20]) containing sorbitol was approved by FDA on 15 October 2021. The new formulation will begin shipping in October 2023. Once the new formulation is available there will be a blend of both formulations in the US market for a period until supply of the DARZALEX single-dose vials without sorbitol (100 mg/5 mL [NDC 57894-502-05] and 400 mg/20 mL [NDC 57894-502-20]) has been depleted. After this transition timeframe, only the new formulation will be available.
• Janssen does not anticipate any disruption in availability or shortage situation for DARAZLEX as a result of this change in formulation.