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SANDOZ' PARLODEL: FDA WILL ASK FOR REMOVAL OF INDICATION

Executive Summary

SANDOZ' PARLODEL: FDA WILL ASK FOR REMOVAL OF INDICATION for prevention of post-partum breast engorgement from the labeling of Parlodel (bromocriptine). The agency is planning to issue a formal request by letter. Should Sandoz not comply with the formal request, FDA said it will issue a notice of opportunity for a hearing on the agency's proposal in the Federal Register. After a Sept. 7 meeting with Sandoz representatives, FDA determined that it would make the formal request. Previously, FDA informally requested companies that market drugs for the prevention of post-partum breast engorgement to remove that indication from their products, since the agency has concluded that there is no need to treat the condition with such drugs. FDA said the company presented revised Parlodel labeling that strengthens the alternative therapy section, and an educational program for physicians and outpatients. Sandoz also proposed a study that would show the need for Parlodel. In a subsequent internal meeting, FDA concluded that it would go public with the actions it has taken in regards to the marketing of drugs for the indication. The agency plans to issue a Talk Paper and submit articles on its position to medical journals. The agency's determination agrees with the recommendations made by FDA's Fertility & Maternal Health Drugs Advisory Committee in June that Parlodel and sex hormones should not be used for the prevention of post-partum breast engorgement ("The Pink Sheet" June 5, T&G-11). Parlodel is also indicated for Parkinson's disease, acromegaly, and hyperprolactinemia-associated dysfunctions. The companies that sell sex hormone drugs for the prevention of post-partum breast engorgement have agreed to stop marketing their products for that indication. The sex hormone products affected include Merrell Dow's TACE and Squibb's Deladumone and Deladumone-OB.
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