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Published on 6 February 2008

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FDA approves child asthma inhaler

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The Food and Drug Administration (FDA) has approved a new inhaled steroid treatment for preventing asthma attacks in young children.

The Asmanex Twisthaler, which is manufactured by Schering-Plough, is the first once-a-day, inhaled corticosteroid medicine for asthma which can be taken by children as young as four.

Two years ago the FDA gave the company approval to sell the product as a maintenance treatment to prevent asthma flare-ups in adults and children above the age of 12.

Now the FDA has said it can be used by children aged between four and 11, and the dosage for these youngsters is 110 micrograms, which is half the adult dose.

Unlike standard inhalers, the Twisthaler does not have a propellant.

It is activated when the patient puts the end in their mouth and takes a breath, and a counter shows how many doses are left.

A small study in children aged between four to 11 showed the Twisthaler reduced day and night-time symptoms, plus “interruptions” of daily life such as emergency medical visits or missing school.

A Schering-Plough spokeswoman said she expected the inhaler to be available in the second half of this year.

Copyright © PA Business 2008

Schering-Plough



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