FDA issues warning letter to researcher about promoting Ipsens Dysport
March 16, 2010 by Ann Deters
Filed under Eyeworld
The U.S. Food and Drug Administration (FDA) has issued a warning to Miami Beach-based researcher Leslie Baumann, M.D., regarding promotional statements she made about Ipsen Biopharm’s (Paris) injectable frown line treatment Dysport (abobotulinumtoxinA), the FDA said in a letter.
Dr. Baumann’s promotional statements about Dysport, which were made to two magazines and NBC’s “Today Show,” were reportedly made in 2006, prior to the drug’s FDA approval. The statements were therefore in violation of the FDA’s regulations on pre-approval promotion, the agency said in its letter.
Dr. Baumann was involved as a researcher in Phase III trials of Dysport, also known as Reloxin, at the time she made the promotional statements, the FDA stated.
Dr. Baumann’s statements about Dysport included claims that its effects “last a month longer than Botox (onabotulinumtoxinA, Allergan, Irvine, Calif.),” the FDA letter cited. The FDA approved Dysport for treating forehead wrinkles and frown lines last spring. Ipsen granted distribution rights for the drug’s cosmetic use to Medicis (Scottsdale, Ariz).
If you enjoyed this post, make sure you subscribe to my RSS feed!
 |
A post by "Ann Deters" http://www.VantageOutsourcing.com Ann Deters passion is to be an advocate for hospitals and surgery centers, allowing them to maximize profits by providing cataract outsourcing services in an efficient and low cost manner. Ann, has been a columnist about health care issue for two decades writing for numerous health care magazines. |
