MOGN gets a slap on the wrist from the FDA over Gliadel wafer ads:
>>WASHINGTON, Jan 31 (Reuters) - The U.S. Food and Drug Administration cited MGI Pharma Inc. (MOGN.O: Quote, Profile , Research) for what it calls a "misleading" advertisement for the company's implanted therapy to treat brain tumors, according to a letter released on Wednesday.
A two-page promotional ad for the product, called gliadel wafer, "fails to disclose its full indication and presents unsubstantiated claims," the letter said.
Representatives for the Bloomington, Minnesota-based pharmaceutical company could not be immediately reached for comment.
In the letter, the FDA said the ad was misleading because it included information about safety and efficacy for patients who had the wafer implanted but did not say that the product was approved for use in addition to surgery and radiation.
The ad, which ran in a journal, also makes various claims about how well the product works that are not supported by evidence, the FDA said. The agency did not name the journal.
In one instance the ad states "Gliadel wafer works at day 1" but does not say the claim is based on animal, not human, studies, according to the Jan. 29 letter.
FDA officials issue dozens of similar letters each year, but resolve most without taking action, which can include fines and other penalties.
The agency requested that MGI Pharma immediately stop using the ad or any others that are similar. It also requested a written response from the company by Feb. 9.
The letter was posted on the FDA's Web site at fda.gov
Shares of the company were up 34 cents, or more than 1 percent, at $19.43 in afternoon trade on the Nasdaq.<<
Cheers, Tuck |
