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KV’s DESI Guaifenesin Trumped by Adam’s 505(b)(2) Product

Last week (7/30/2008) , FDA announced that it seized timed-release guaifenesin products from KV Pharmaceutical.  In 2002 the FDA determined this DESI product to be a safety hazard to children.  The manufacturers, including KV Pharmaceutical (Warning Letters: see page 23)  were told to stop manufacturing by November 2003 unless they received NDA approval.  Adams Respiratory Therapeutics obtained NDA approval via 505(b)(2). FDA then sent a notice (72 FR 29517) in May 2007 telling all other manufacturers to stop marketing the drugs.  According to the FDA news release, KV did not stop manufacturing or marketing.  It is unclear if other companies are still marketing these drugs but FDA’s action against KV indicates what will happen if they are caught.