June 8, 2006

The FDA has issued a warning letter to Sandoz citing violations of the Federal Food, Drug, and Cosmetic Act's (FDCA) advertising standards in relation to print ads for bupropion hydrochloride extended-release tablets (SR).

The letter, sent May 26 and posted on the FDA's website May 30, finds that Sandoz's print advertisement for SR violates the FDCA by improperly using a reminder ad for SR because the drug, which is used to treat depression, has a boxed warning, the letter says. The FDCA does not allow reminder ads, which call attention to the name of a drug product without telling what its indications are, to be used when there is a boxed warning.

The company also failed to include SR's side effects, contraindications and effectiveness data in the ad. Reminder ads are exempted from providing this data, but since a reminder ad is not allowed for SR, this additional information was necessary, the letter adds.

The FDA called on Sandoz to "immediately cease" the ad and asked for a response by June 12. Sandoz responded in a May 30 letter that the ads have not run since last October and will not be used again, Steve Eisenberg, a company spokesman said.

To view the letter, go to: http://www.fda.gov/cder/warn/2006/Bupropion-letter.pdf (http://www.fda.gov/cder/warn/2006/Bupropion-letter.pdf)