November 14, 2006
Product News from the 11/14/06 News Brief
Abbott has announced that the FDA approved an expanded indication for Humira (adalimumab) that includes inhibiting structural joint damage and improving physical function in patients with psoriatic arthritis. The expanded indication is in addition to the psoriatic arthritis approval granted in October 2005. Medicis and Dow Pharmaceutical Sciences announced that the FDA has approved Ziana (clindamycin phosphate and tretinoin) for the topical treatment of acne vulgaris in patients 12 years or older. The FDA has granted Mylan Laboratories approval for its generic version of Alza Corporation’s Ditropan XL (oxybutynin chloride extended-release) tablets. Ditropan XL had US sales of approximately $380 million during the 12-month period ended June 30, 2006. The FDA approved Boehringer Ingleheim’s Mirapex for the treatment of Restless Legs Syndrome. Mirapex was first approved by the FDA in 1997 to treat Parkinson’s disease. Roche and the FDA have notified healthcare professionals of revisions to the precautions/neuropsychiatric events and patient information sections of the prescribing information for the flu treatment Tamiflu. There have been postmarketing reports, mostly from Japan, of self-injury and delirium with the use of Tamiflu in patients with influenza. People with the flu, particularly children, may be at an increased risk of self-injury and confusion shortly after taking Tamiflu and should be closely monitored for signs of unusual behavior, the FDA said.