Former FDA deputy chief counsel Gerald F. Masoudi has rejoined the agency as its new chief counsel, replacing Sheldon Bradshaw who left the agency in September for private practice.
Lilly says labeling for Zyprexa and Symbyax reflects recent data
Eli Lilly & Co. says updated labeling for its atypical antipsychotics Zyprexa (olanzapine) and Symbyax (olanzapine and fluoxetine HCl) reflects recently completed pooled analyses of clinical trial data in adults and adolescents, information from two non-Eli Lilly studies, and discussions with the FDA.
The FDA has approved some labeling changes to erectile dysfunction drugs— including Viagra, Cialis, and Levitra—to display more prominently an existing risk on the potential for sudden hearing loss.
A CSL Behring LLC direct-to-consumer promotional brochure and site (www.HemophiliaB.com) for Mononine (coagulation Factor IX) has been cited by the FDA’s biologics Center for making unsubstantiated superiority claims over Wyeth’s BeneFIX.
FDA commissioner Andrew von Eschenbach has approved creation of an agency Pediatric Review Committee (PeRC) to provide consultation on and general review of pediatric information submitted to the FDA in pediatric plans, assessments, and studies conducted by sponsors and applicants.
Federal preemption fails in award against Wyeth products
Federal preemption arguments failed in October to prevent a Nevada jury from awarding three women $134.5 million in their suit against Wyeth over its hormone replacement products Premarin and Prempro that they alleged caused their breast cancer.
Independent Vermont senator Bernie Sanders has introduced federal legislation (S. 2210) to replace the current patent and non-patent market exclusivity system for drugs in place since the 1984 Waxman-Hatch Act.
Enforcement trends in recent years between the FDA’s Center for Drugs and its Center for Biologics, as measured by numbers of citations for violating advertising/promotion regulations, appear to be on divergent paths.