Ortho oncology promotions
Ortho's Partners in Oncology brochure, including promotional statements for Leustatin (cladribine), Duragesic CII (fentanyl transdermal system), Ergamisol (levamisole), Sporanox (itraconazole) and Nizoral (ketoconazole), lacks fair balance because it fails to present balancing risk information to its claims of efficacy, FDA says in a May 10 letter. "This violation is particularly troublesome because it went on for quite some time," the agency states. "The Form FDA 2253 indicated that the brochure was disseminated in May of 1998, yet the Form FDA 2253 was not submitted until May 25, 1999"
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth