CARTER-WALLACE ASSURES CLIENTS OF CONTINUED ORGANIDIN SUPPLY

CARTER-WALLACE ASSURES CLIENTS OF CONTINUED ORGANIDIN SUPPLY while the company attempts to convince FDA that the drug (iodinated glycerol) should remain on the market. The company said it is requesting a meeting with FDA to discuss the issue. Carter- Wallace told its pharmaceutical customers in an April 26 letter that "Wallace will continue to provide you Organidin family products pending resolution of the issues raised by the FDA request. We have confidence in the safety and effectiveness of the products and we are optimistic that we will be able to resolve the FDA's concerns." Among the products that contain iodinated glycerol are Carter- Wallace's Organidin (tablets, solution and elixir), Theo-Organidin (iodinated glycerol plus theophylline), Tussi-Organidin (plus codeine phosphate) and Tussi-Organidin DM (plus dextromethorphan hydrobromide). In an April 15 warning letter, FDA asked Carter-Wallace and about 60 other companies to discontinue marketing products containing the mucolytic expectorant, which is used to treat respiratory conditions, because of safety concerns. Iodinated glycerol is a DESI drug for which an NDA has never been approved. FDA said it "has reviewed information related to the carcinogenic potential of iodinated glycerol and has concerns about its safety in humans." A National Toxicology Program study published in March 1990 found that rats and mice exposed to Organidin had higher rates of mononuclear cell leukemia and pituitary adenoma than controls. The agency requested that the companies notify FDA within 15 days of receipt of the letter that they will discontinue marketing iodinated glycerol products. In addition, FDA requested estimates of the quantity of drug manufactured in the last 12 months, frequency of shipments, amount in inventory and amount in distribution. A. L. Labs announced April 27 that it had received the FDA letter requesting discontinuation of iodinated glycerol products marketed by its Barre-National subsidiary. The company estimated that the products account for 2% of the firm's total revenues. A. L. Labs said that it will continue to "monitor and review information related to FDA's request." A number of other companies market iodinated glycerol products, including: Aligen; Bioline; Cenci; Copley; Duramed; Econlab; Eon Labs; Equipharm; Everett; Geneva; Genetco; Goldline; Halsey; Harber; Hi-Tech; Invamed; LuChem; Major; Moore; Mova; Muro; Par; Pharmaceutical Associates; Pharmaceutical Basics; Roxane; Schein; Trinity Tech; UDL; and United Research. Carter-Wallace expressed surprise at the FDA request for Organidin's discontinuation. In its letter to customers, the company maintained that at a March 1992 meeting, FDA's Pulmonary- Allergy Drugs Advisory Committee "recommended that the products be allowed to remain on the market, with the company conducting further analysis of the existing data" ("The Pink Sheet" March 30, 1992, p. 5). Carter-Wallace said it has "data in development" that will support the safety and efficacy of Organidin. At the meeting, the advisory committee voted six-to-three to allow Organidin to remain on the market pending an agency review of efficacy data to determine the benefit of the drug versus its potential carcinogenicity. The committee asked FDA to focus on data from the National Mucolytic Study, published in December 1990. The committee agreed five to four that if the reanalysis of that study did not prove the efficacy of Organidin it would recommend that Carter-Wallace conduct a pivotal trial to prove effectiveness. The committee also recommended a "Dear Doctor" letter to alert physicians of the product's carcinogenic potential.