This voluntary decision is a result of an internal BVL review, which indicated that routine preventive maintenance did not happen at a specified time for some manufacturing equipment. This required maintenance included steps to ensure that machinery meet all qualifications before being used again. BVL is halting production to conduct a site-wide assessment to determine the potential impact, if any, and will implement any corrective actions if needed.
This temporary suspension of manufacturing by BVL impacts the production and release of DOXIL®, which is currently in short supply and not available beyond product already allocated to patients in the DOXIL® C.A.R.E.S. Physician Access Program. We are not able to estimate timing when DOXIL® may return to the market as BVL has not provided a commitment on when its manufacturing operations will resume. In light of this situation, patients should speak with their physicians about alternate treatment options.