FDAnews Drug Daily Bulletin


Sept. 6, 2005

The FDA has issued California-based drugmaker SuperGen a warning letter for using a misleading mechanism of action booth panel and handout to promote its leukemia drug Nipent.

The promotional materials for Nipent (pentostatin), a single-agent treatment for both untreated and alpha-interferon-refractory hairy cell leukemia, fail to present any risk information, contain an unsubstantiated claim regarding the drug's mechanism of action and overstate Nipent's safety and efficacy, according to a recent warning letter issued by the FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC).

SuperGen's materials "present numerous efficacy claims with emphasizing illustrations but entirely omit risk information, including the important risk information from the Boxed Warning (e.g., severe renal, liver, pulmonary and CNS toxicities at higher doses, and fatal pulmonary toxicity when combined with fludarabine) and the Warnings, Precautions and Adverse Reactions sections" of Nipent's labeling, the warning letter states.

DDMAC acknowledged that SuperGen made Nipent's product labeling available with the materials, but the agency noted, "merely disseminating the [labeling] with these promotional materials is not sufficient to overcome these violations."

The warning letter marks the third communication SuperGen has received from DDMAC regarding Nipent. In 1997, SuperGen received an untitled letter for using a misleading convention panel that lacked fair balance with respect to content and presentation. In 2001, DDMAC issued the firm a second untitled letter for disseminating a journal advertisement that included misleading claims about Nipent's long-term safety and promoted unapproved uses of the drug

To view the warning letter, go to http://www.fda.gov/cder/warn/2005/Nipent_warn_ltr.pdf (http://www.fda.gov/cder/warn/2005/Nipent_warn_ltr.pdf).