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.
David Calabrese of OptumRx Talks Top Three Drugs in Pipeline, Industry Trends in Q2
July 1st 2020In this week's episode of Tuning Into The C-Suite podcast, MHE's Briana Contreras chatted with David Calabrese, R.Ph, MHP, who is senior vice president and chief pharmacy officer of pharmacy care services company, OptumRx. David is also a member of Managed Healthcare Executives’ Editorial Advisory Board. During the discussion, he shared the OptumRx Quarter 2 Drug Pipeline Insights Report of 2020. Some of the information shared includes the three notable drugs currently being reviewed or those that have been recently approved by the FDA. Also discussed were any interesting industry trends to watch for.
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