CNN ran a story today to increase public awareness that there are hundreds of drugs consumed in the U.S. that have never been formally approved by the FDA. For professionals, the FDA has a web page devoted to this topic. Some of these products were subject to the DESI review process, but it is well known that producers have departed from these products in regards to strength and composition. As the CNN story points out, producers have added unapproved indications; for instance, quinine being promoted for leg cramps. 505(b)(2) is the most likely approval route for some of these drugs. However, most of these drugs are produced by low-cost, high-volume manufacturers and the time and cost of a 505(b)(2) is often prohibitive. We suggest that this represents an opportunity for the shrewd investor.
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