Friday, October 30, 2009

FDA Says Yes to IV Peramivir To Treat Flu

The FDA announced today that it has issued an emergency use authorization (EUA) for the investigational antiviral drug peramivir intravenous (IV) in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza infection who are admitted to a hospital.

Specifically, IV peramivir is authorized only for hospitalized adult and pediatric patients for whom therapy with an IV drug is clinically appropriate, based on one or more of the following reasons:

  • the patient is not responding to either oral or inhaled antiviral therapy, or

  • when drug delivery by a route other than an intravenous route -- e.g., enteral (absorbed by the intestines) or inhaled -- is not expected to be dependable or feasible;

  • for adults only, when the clinician judges IV therapy is appropriate due to other circumstances.
I've been following this drug for sometime now, and I'm glad to see that it's found a niche during this flu pandemic.

Additional Related Information From The FDA:
EUA Letter of Authorization
EUA Fact Sheet for Health Care Providers
EUA Fact Sheet for Patients and Parents/Caregivers
Information for Healthcare Professionals Sheet (HCP) on mandatory adverse event reporting for emergency use of peramivir under EUA

Previous Posts:
FDA Search Widget of Fraudulent H1N1 Products
Got Wine Flu?
Flu.gov Updated by HHS - New Resources Added

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