FDA Actions in Brief August 2010 (Tribenzor, Daiichi Sankyo, Aricept, Eisai and Pfizer, Daytrana, Glassia, Zuplenz, Infergen, Cuvposa)

Recent FDA Approvals (through July 2010) related to Tribenzor, Daiichi Sankyo, Aricept, Eisai and Pfizer, Daytrana, Glassia, Zuplenz, Infergen, Cuvposa

Olmesartan medoxomil, amlodipine, hydrochlorothiazide (Tribenzor, Daiichi Sankyo) was approved for the treatment of uncontrolled hypertension.

A once-daily, higher-dose donepezil HCl (Aricept, Eisai and Pfizer) 23-mg tablet was approved for the treatment of moderate-to-severe Alzheimer's disease.

Methylphenidate transdermal system (Daytrana, Shire) was approved for the treatment of attention deficit hyperactivity disorder in adolescents aged 13 to 17 years.

Ondansetron (Zuplenz, Strativa) was approved for the prevention of postoperative, highly and moderately emetogenic cancer, chemotherapy-induced, and radiotherapy-induced nausea and vomiting.

Consensus Interferon (Infergen, Three Rivers Pharmaceuticals) expanded labeling was approved to include daily use in combination with ribavirin for the retreatment of chronic hepatitis C patients.

Glycopyrrolate (Cuvposa, Shionogi Pharma) oral solution was approved for the treatment of chronic severe drooling caused by neurologic disorders in children aged 3 to 16 years.