The FDA on Monday accused Pfizer of false advertising for its anti-schizophrenia drug Geodon, CNNMoney reported.The FDA, in a letter posted on its Web site, said that a Pfizer advertisement appearing in a medical journal "is false or misleading because it omits important risk information and contains unsubstantiated superiority claims." The FDA said that Pfizer omitted health risks that have been attributed to the injectable drug Geodon, including diabetes, high blood pressure and neurological disorders. The FDA said that Pfizer used the term "movement disorders" to refer to a disorder called tardive dyskensia, a description that is "insufficient" to communicate its seriousness."By omitting these risks, the journal ad misleadingly suggest that Geodon for Injections is safer than has been demonstrated," said the FDA letter.
Vivus has received a $140 million milestone payment from KV Pharmaceutical related to the rights for menopause treatment Evamist. Under the terms of the transfer, Vivus received an upfront payment of $10 million upon the May 15 closing. Vivus became eligible for an additional payment following the approval by FDA on July 27, 2007. VIVUS is eligible to receive two additional one-time milestone payments based on sales milestones for Evamist through the term of the agreement with KV. The first, a $10 million payment will be due to Vivus when Evamist achieves $100 million in net annual sales and the second a $20 million payment will be due to VIVUS when Evamist achieves $200 million in net annual sales.