FDA calls on contractors, India to counter Ben Venue drug shortages
A non-FDA approved drug from India and U.S. contract manufacturers will address cancer drug shortages resulting from production and quality problems at Ben Venue Laboratories' now notorious Ohio plant.
The FDA announced both actions Feb. 21, the culmination of a frantic bid to alleviate shortages of Doxil, Johnson & Johnson's ($JNJ) injectable ovarian cancer chemotherapy drug, and methotrexate, a preservative-free treatment for acute lymphocytic leukemia in children, among other diseases, Cleveland's The Plain Dealer notes in coverage of regulators' decision. Health officials had previously feared they had about two weeks before running out of supplies of the drugs.
India's Sun Pharma makes Lipodox, which has the same active ingredients as Doxil. Detroit's Caraco Pharmaceutical Laboratories will distribute the treatment domestically, according to the article. In a highly unusual move, FDA signed off on the Sun drug's temporary use even though it isn't approved yet in the U.S. Regulators said in a statement they consider this move "in rare cases" in which a crucial drug suddenly becomes scarce and its absence can't be addressed by approved drugs.
A small army of companies will step in to boost production of a preservative-free, generic methotrexate, which patients receive under both the Rheumatrex and Trexall brand names. Those companies include Illinois- based APP Pharmaceuticals ($APPX) and Hospira ($HSP); Mylan ($MYL) in Pennsylvania and Germany's Sandoz, which is also based in New Jersey. Supply should increase over the next few weeks, according to the story.
Ben Venue voluntarily stopped production at its Ohio facility after complaints late last fall that some batches of Doxil contained metal particles. That's a big issue because Ben Venue had been the only U.S. maker of the drug. The beleaguered company was also one of the largest manufacturers of methotrexate, an injectable treatment.
Here's a pretty sobering example of how bad things became: Patients who needed Doxil for their treatment suddenly faced rationing. And some locations have already endured scarce supplies of preservative-free methotrexate for some time, according to the paper.
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