FDA actions in brief, September 2007


Briefs of FDA actions/approvals of drugs, doses, and indications

Key Points

Two lower doses (30 and 45 mg) of oseltamivir (Tamiflu, Roche) were approved for the treatment and prevention of influenza types A and B in patients aged ≥1 year.

A new dosage strength of carbidopa, levodopa, and entacapone (Stalevo, Novartis) was approved for the treatment of Parkinson disease (PD) in patients with signs and symptoms of end-of-dose wearing off. The new dosage includes carbidopa 50 mg, levodopa 200 mg, and entacapone 200 mg.

FDA has approved a metered-dose transdermal spray formulation of estradiol (Evamist, Vivus) for the treatment of moderate-to-severe vasomotor symptoms due to menopause.

An intranasal spray delivery formulation of thrombin, topical, bovine (Thrombin-JMI Epistaxis Kit, King) was approved for use to aid in stopping epistaxes.

A new 3,000-IU dose of antihemophilic factor (recombinant), plasma/albumin-free method (Advate, Baxter) was approved for the prevention and control of bleeding episodes and for peri-operative management in patients with hemophilia A.

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