Cephalon, Frazer, PA, Feb. 27 (Rockville, MD).(DDMAC PROMO UNTITLED LETTERS)

FDA warned that the company's marketing piece that recommended uses for Provigil (modafinil) Tablets [GIV] (Provigil) had not been reviewed or approved by FDA.

The agency stated that the marketing literature included broadening of indications and lacked proper directions for use.

Regarding omission of risk, the agency noted that the handout failed to include any risk information, including a critical caveat from labeling, which was: "Patients with excessive sleepiness, including those taking PROVIGIL, should be frequently reassessed for their degree of sleepiness and, if appropriate, advised to avoid driving ..."

This especially is concerning given the claims implying that Provigil is beneficial with respect to avoiding driving accidents, FDA stated.

Next, FDA noted that regulations require companies to submit any labeling or advertising devised for promotion of the drug product at the time of initial dissemination of the labeling and at the time of initial publication of the advertisement for a prescription drug product. The firm failed to do so.

The agency stated that the firm must stop distributing the misleading literature.

Further, it stated because the violations described above are serious, the agency requested that the firm submit a comprehensive plan of action detailing how it would disseminate truthful, non-misleading, and complete corrective messages about the issues discussed in the letter to the audience that received the violative promotional materials. F- B; Doc. 14103W

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