FDA approves revised safety label for Xenical
BETHESDA, Md. The Food and Drug Administration on Wednesday notified healthcare professionals and patients that it has approved a revised label for Xenical to include new safety information about cases of severe liver injury that have been reported rarely with the use of the medication.
The agency also is adding a new warning about rare reports of severe liver injury to the OTC Drug Facts label for GlaxoSmithKline’s Alli.
Xenical and Alli are medications used for weight-loss that contain different strengths of the same active ingredient, orlistat. Xenical (orlistat 120 mg) is available by prescription and Alli (orlistat 60 mg) is sold over-the-counter without a prescription.
This new safety information, originally announced in August 2009, is based on FDA’s completed review of orlistat.
Pharmavite names CEO
NORTHRIDGE, Calif. Pharmavite on Tuesday named Doug MacLean as the company’s new CEO.
MacLean comes to Pharmavite from TalkingRain, a Seattle-based beverage company focused on health-conscious consumers, providing natural waters and functional beverages, where he most recently served as CEO. During his tenure, he led the organization from a start-up to a successful, independent beverage company.
At Pharmavite, McLean’s strategic priorities will include accelerating the growth of new products in the United States in conjunction with Pharmavite’s parent company, Otsuka Pharmaceutical Corporation, and maintaining a continued focus on the financial health and effectiveness of Pharmavite’s overall business.
MacLean officially will join Pharmavite June 1.
Sen. Harkin poses questions for FDA following cough-cold medicine recall
WASHINGTON Sen. Tom Harkin, D-Iowa, on Monday penned a letter addressing Food and Drug Administration commissioner Margaret Hamburg following the recall of 40 varieties of children’s and infants’ formulations of Tylenol, Motrin, Zyrtec and Benadryl by Johnson & Johnson’s McNeil Consumer Healthcare.
“I commend you for FDA’s leadership in responding to this crisis, both in terms of your outreach to the public and your increased regulatory activity,” Harkin wrote. “However, I am interested in ensuring that, as a public health agency whose mission is to protect the American public, you have sufficient authority to prevent and respond to contamination of the drug supply. I am especially concerned because so many of the drugs at issue in this recall were intended for infants and children.”
Harkin, who is chairman of the Senate health, education, labor and pensions committee that has jurisdiction over the FDA, posed questions regarding the recall, events leading up to it and consumer complaints.
Harkin was particularly interested in the voluntary recall process, asking if the FDA had initiated the request for a voluntary recall, and had they been denied that request, would the agency have had the authority to mandate a recall.
Harkin requested FDA respond to his list of questions by June 11.