Janssen Products, LP, has announced that it is coordinating with the Food and Drug Administration to create additional supply of DOXIL using an alternative manufacturing process.
In a letter to healthcare providers, Janssen reported that it is manufacturing the drug through a new manufacturing process involving collaboration between Ben Venue Laboratories and another supplier. This manufacturing process has not been approved by the FDA but Janssen has said that is working with the agency to seek approval and ensure a consistent supply. The FDA is currently exercising its regulatory discretion for making Janssen’s DOXIL 20 mg/10 mL vials available.
For ongoing updates on the DOXIL supply, please visit www.DOXIL.com or www.DOXILSupply.com.