FDA actions in brief, June 2008 (Rotarix, Pantanase, Treximet, Aplenzin, Relistor, Actonel, Vyvanse, Advair Diskus 250/50, Orencia)

Recent FDA approvals and indications (through June 2008) related to Rotarix, Pantanase, Treximet, Aplenzin, Relistor, Actonel, Vyvanse, Advair Diskus 250/50, and Orencia.

Rotavirus vaccine, live, oral (Rotarix, GlaxoSmithKline) was approved for the prevention of rotavirus gastroenteritis in infants.

Olopatadine nasal spray (Pantanase, Alcon) was approved for the relief of the symptoms of seasonal allergic rhinitis in patients aged ≥12 years.

A combination of sumatriptan and naproxen (Treximet, GlaxoSmithKline) was approved for the acute treatment of migraine attacks with or without aura in adults.

Methylnaltrexone (Relistor, Progenics/Wyeth) was approved for the treatment of opioid-induced constipation in patients with advanced illness who are receiving palliative care when response to laxative therapy has not been sufficient. A once-monthly dose of risedronate (Actonel, Procter & Gamble/Sanofi-Aventis) was approved for the treatment and prevention of postmenopausal osteoporosis.

Lisdexamfetamine (Vyvanse, Shire) was approved for the treatment of attention- deficit/hyperactivity disorder (ADHD) in adult patients.

Fluticasone/salmeterol (Advair Diskus 250/50, GlaxoSmithKline) was approved for the reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD) who have a history of exacerbations.

Abatacept (Orencia, Bristol-Myers Squibb) was approved for the reduction of the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in pediatric patients aged ≥6 years.