N.J. Rep. criticizes FDA over weaker antidepressant warnings for children
WASHINGTON Rep. Mike Ferguson, R-N.J., is criticizing the Food and Drug Administration, for its revised antidepressant medication guides because the warnings for children take the medications have been weakened compared to the old guide.
Ferguson said the guides include more generalized information regarding the risks for children, teenagers and young adults taking antidepressants. He also stated that the new guides use a generic warning that combines all three age groups into one category and abbreviates safety information.
In October 2003, the FDA issued an advisory warning of the increased risk of suicide in pediatric patients taking selective serotonin reuptake inhibitors for depression. After reviewing more data from pediatric studies, the agency told antidepressant manufacturers to revise their product labeling to include the risk of suicide in children and adolescents.
Haggerty appointed Mylan senior VP and global general counsel
PITTSBURGH, Pa. Mylan has announced that Joseph Haggerty has been appointed as senior vice president and global general counsel.
Haggerty will manage and oversee all legal issues and the provision of legal services, counsel and advice globally to all members of Mylan’s senior management, as global general counsel.
Haggerty joins Mylan from Sanofi-Aventis, where he served as vice president, general counsel, and corporate secretary.
“I am thrilled to be joining Mylan at this exciting time in the company’s history,” Haggerty said. “I look forward to joining the already impressive global management team and supporting them and their operations with my counsel as Mylan becomes one of the leading quality generic and specialty pharmaceutical companies in the world.”
Depomed and King terminate Glumetza agreement
MENLO PARK, Calif. and BRISTOL, Tenn. Depomed and King Pharmaceuticals have terminated their promotional agreement for Glumetza, a drug used to treat Type 2 diabetes.
Under the agreement, King has paid Depomed $30 million in termination and other fees. King will fulfill its promotion obligations through the end of 2007 and Depomed will not pay a promotion fee to King for the quarter ending on Dec. 31.
Carl A. Pelzel, president and chief executive officer of Depomed said that, “Our joint efforts in launching Glumetza have demonstrated the product’s value to patients and its commercial potential. Discussions with potential new marketing partners for Glumetza are already underway. We are confident that we can identify a partner that will assist us in continuing to drive growth in the primary care, endocrinology and other key healthcare markets. In the meantime, a portion of the proceeds from this termination agreement will be earmarked for the continued marketing and promotion of Glumetza.”