FDA DESI PROGRAM FOCUSING ON UNAPPROVED TOPICAL CORTICOSTEROIDS

FDA DESI PROGRAM FOCUSING ON UNAPPROVED TOPICAL CORTICOSTEROIDS in lotion, ointment, and cream dosage forms. The agency announced in a March 6 memo to its regional and district directors that FDA is ready to follow-up on DESI effective Rx topical preparations. The agency said it has divided this category into segments, and will first take action on topical corticosteroids. FDA requested that district directors issue reg letters to firms marketing unapproved topical corticosteroids. The list of mfrs. and products attached to FDA's memo include: Parke-Davis' Anusol-HC Cream; Forest's Dureze Solution; Maurry Biological's Otomycin, and Ophthalmic HC Acetate Suspension 0.5% and 1%; and Heran Pharmaceuticals' Gly-Cort Liquid. A sample reg letter sent to district directors states that the manufacturer's product is "regarded to be a new drug within the meaning of . . . the FD&C Act and . . . no approval of an application filed by you . . . is effective for such drug. Consequently, the continued marketing of the above listed product(s) or any other product(s) you may market, without an approved NDA for an identical, similar or related drug constitutes a violation of Section 505 of the FD&C Act." The agency will require a reply from the mfr. within 10 days of receipt of the letter stating what action will be taken to discontinue marketing of the product. "If significant stocks of the drug remain in trade channels at this time, we will require that they be immediately recalled to the whsle. and direct consignee level," FDA added. The agency memo notes that the DESI program does not apply to Rx products containing 0.5% or less of hydrocortisone. FDA said this dosage will ultimately be dealt with under the OTC reivew. FDA announced in the OTC External Analgesic Tentative Final Monograph, published in February 1983, that hydrocortisone ointments and creams in strengths of 0.5% or less could be marketed OTC. Single entity hydrocortisone suppositories are also not covered under this DESI action. FDA has already taken action on hydrocortisone combo products in suppository form, including Wyeth's Wyanoids-HC and Parke-Davis' Anusol-HC. FDA is wrapping up the DESI program with its review of this category of DESI products. In order to implement DESI, the agency devided DESI drugs into two groups -- Rx drugs for which final determinations on effectiveness have been made; and DESI and other pre-1962 Rx drugs for which final determinations on their regulatory or legal status have not been made. The first group of DESI drugs was divided into seven categories; FDA has completed regulatory action on the first six.