Sandoz' Parlodel
Executive Summary
FDA's Fertility and Maternal Health Drugs Advisory Committee will meet June 1-2 to discuss the use of Parlodel for lactation prevention. At issue is whether any potent drug should be used to suppress postpartum lactation. Sandoz submitted comments Feb. 15 to FDA in response to a citizen petition filed Nov. 29 by Health Research Group and the National Women's Health Network, which called for the deletion of lactation supression labeling from four products, including Parlodel, on the grounds that the natural resolution of lactation does not warrant the risks of reported side effects ("The Pink Sheet" Dec. 5, T&G-12).