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Another “unapproved” drug needs a 505(b)(2) approval

FDA is continuing to act on its promise made in January 2007 to remove products from the market that it considers unapproved.  These products, some stemming from the DESI process, have been with us many years. The latest casualty is Colchicine for Injection.  On February 6, FDA announced it was taking enforcement action because the products are associated with a variety of serious adverse events, some potentially fatal.

The FDA observes that manufactures that wish to continue to make this product must obtain a FDA approval of a NDA.  Most of these approvals are based on a  505(b)(2) submission.  FDA indicates that it has reason to believe the a narrow margin of safety exists between a therapeutic dose (meaning it believes there is efficacy) and a toxic dose.  Manufacturers thus need to establish better labeling through adequate safety and dose ranging studies.