Emetrol reg letter

Executive Summary

FDA sent Rorer an April 5 regulatory letter saying that continued marketing of the anti-emetic Emetrol is a violation of the FD&C Act, since the product does not comply with the final rule on OTC anti-emetic drugs published on May 2, 1988. The formulation contains "non-permitted active ingredients: dextrose, levulose and phosphoric acid," the letter says. According to Rorer, the letter was referred to Adria Labs, since it now owns Emetrol. Adria acquired Emetrol, along with Rorer's nitroglycerin ointment Nitrol, in an August 1987 product trade agreement. Rorer in turn acquired Adria's analgesic Myoflex.