FDA Moves Against Marketed Unapproved Human Drugs

A recent article in Food and Drug Law Institute’s “Update” magazine discusses recent FDA actions against companies marketing unapproved drugs. According to the article, the FDA began an enforcement initiative with respect to such drug products in June 2006 to “ensure that all drugs marketed in the United States meet safety, effectiveness, manufacturing, and labeling standards.” Since FDA began this initiative, FDA has publicly taken action with respect to many marketed unapproved drugs, including carbinoxamine, colchincine for injection, hydrocodone, and guaifenesin. Since this article was published, FDA announced a new enforcement action against Scientific Laboratories for manufacturing and distributing several unapproved drugs.

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