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Back To Vidyya Tamiflu Granted FDA Approval For Pediatric Indications


Drug May Be Used In The Treatment Of Flu In Children 1 Year And Older

Hoffmann-La Roche announced on 14 December 2000, that the US Food and Drug Administration granted marketing approval for a pediatric treatment indication for its influenza antiviral Tamiflu(TM) (oseltamivir phosphate).

Tamiflu, the number one prescribed medicine for treating the influenza in adults, will now be available in a liquid suspension for the treatment of acute illness due to influenza for children 1 year and older. The pediatric indication will be available by mid-January 2001 and may also be used to treat adults who cannot swallow a capsule.

Tamiflu (oseltamivir phosphate), co-developed with Gilead Sciences of Foster City, California, is a systemic treatment for all common strains of influenza (types A & B) and is available in a convenient pill form. Tamiflu was approved by the U.S. Food and Drug Administration in October 1999 for the treatment of uncomplicated influenza in adults and is now the market leader in antiviral influenza treatment.

Each year, up to 40 million Americans develop the flu, an average of about 300,000 are hospitalized, and 20,000 to 40,000 people die from influenza and its complications. The influenza virus is highly contagious and is transmitted when droplets are shed by an infected person during sneezing or coughing. A person becomes infected by breathing in these droplets. The virus then settles into the entire respiratory system, and begins replicating 24 hours before symptoms are discovered. An infected person can pass on the disease for four to five days and influenza may remain in a local area for up to six weeks.


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Editor: Susan K. Boyer, RN
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