FDA brings Sun's Doxil copy online to fix shortage
Fresh off its cobbled-together solution to a methotrexate shortage, the FDA says it's sewn up an alternate supply of the scarce cancer drug Doxil. The agency has approved a substitute for the Johnson & Johnson ($JNJ) treatment, made by India's Sun Pharma. The alternative treatment, Lipodox, will be imported from India in a "temporary, limited arrangement" until J&J can secure its own Doxil supplies.
"It's wonderful news," FDA's Sandra Kweder told USA Today. She said the deal with Sun Pharma will address the Doxil shortage "for the forseeable future."
Doxil is used to treat a number of cancers. It's been scarce for months, ever since the contract supplier Ben Venue Laboratories developed manufacturing problems. J&J has been looking for a different manufacturer--and working with Ben Venue to get its production back up to speed--but the shortage has remained. In January, J&J announced it had enough Doxil for patients who've been on its waiting list since last year, but that new supplies of the drug wouldn't be forthcoming from Ben Venue in 2012. It's hoping to announce a new long-term supplier soon.
In the meantime, Ben Venue has shut down its Bedford, OH, plant for an overhaul after FDA inspectors found repeated and serious manufacturing violations. The drugmaker's ongoing woes have contributed to several critical drug supply problems, including the methotrexate shortage the FDA was scrambling to alleviate last week. The agency got Ben Venue to release some stocks of its preservative-free version--"following confirmation of its safety"--while other manufacturers agreed to step up production. Now, the agency says it has put an approval application from APP Pharmaceuticals ($APPX) on its fast track, aiming for that company's version to reach the market next month.