On August 28, the FDA issued a warning letter to Forest Laboratories requiring immeidate remediation conderning claims of safety and efficacy made for Bystolic in the product's marketing materials.  The content of the warning was released today.

According to the warning letter, 'The  Division of Drug Marketing, Advertising, and Communications (DDMAC) of the U.S. Food and Drug Administration (FDA) has reviewed an 8-Page Launch Journal Ad (44-1012123) uournal ad) for BystoliclI (nebivolol) Tablets (Systolic) submitted by Forest Laboratories, Inc. (Forest) under cover of Form FDA-2253.  The journal ad makes unsubstantiated superiority and mechanism of action claims, omits and minimizes risks associated with the use of Systolic, and makes unsubstantiated efficacy claims for the drug. Thus, the journal ad misbrands the drug in violation of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 352(n) and 321 (n), and FDA implementing regulations. 21 CFR 202.1 (e)(3)(i); (e)(5); (e)(6)(i); and (e)(6)(ii).  These violations are concerning from a public health perspective because they suggest that Systolic is safer and more effective than has been demonstrated by substantial evidence."

The full text of the FDA Warning Letter may be viewed at: http://www.fda.gov/cder/warn/2008/Bystolic-wl.pdf

Source: FDA


Zynchros Pharmacy Services