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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.
Employers Face Barriers With Adopting Biosimilars
March 1st 2022Despite the promise of savings billions of dollars in the United States, adoption of biosimilars has been slow. A roundtable discussion among employers highlighted some of the barriers, including formulary design and drug pricing and rebates.
