The production method uses the “areas of the Ben Venue facility available for production and [an additional and unnamed supplier] partnering on the remaining elements of the manufacturing process,” Lisa Vaga, a spokeswoman for Janssen, told Outsourcing-Pharma.com.
She added that Janssen, a Johnson & Johnson subsidiary, developed the alternate manufacturing approach “to re-establish Doxil availability as quickly as possible."
A history of quality failures at the Ben Venue facility led to a consent decree from the Food and Drug Administration (FDA) which, while halting most manufacturing operations, allowed the site to begin producing some drugs that would otherwise be in short supply.
Nevertheless, shortages of Doxil have persisted since 2011.
Janssen also said it continues to look for new CMOs to work with in developing Doxil. “As part of our ongoing efforts in ensuring sufficient supply, we also continue to take the steps needed for our long-term transition to new suppliers,” Vaga added.
Shortages and Regulatory Discretion
The released lot is the third made using the alternative manufacturing approach to be cleared by the FDA, which OKed the previous supplies in late January and March.
The Doxil shortage also forced the FDA to allow Sun Pharma to import a version of Doxil in late January. However, the Lipodox injection from Sun “has not been approved by FDA, and therefore, FDA cannot consider it a ‘generic of Doxil,’” the FDA said in a Q&A on the temporary approval.
FDA’s exercise of enforcement discretion for the importation of Lipodox is temporary, it says, though the agency noted that this is not a rare occurrence.
It has temporarily allowed the import of eight drugs to address shortages in the past two years, including four currently in short supply: leucovorin injection, ethiodol injection, thiotepa injection and foscarnet injection.
An FDA spokesman also previously said the faster approval of Sun’s version of Doxil would not have been expedited if the consent decree wasn’t issued and did not create a shortage.