-- Scott Roberts
FRIDAY, April 18, 2014 (HealthDay News) -- Ragwitek has been
approved by the U.S. Food and Drug Administration to treat allergy
to short ragweed among adults aged 18 to 65.
The once-daily tablet contains an extract from short ragweed
(Ambrosia artemisiifolia) pollen, the agency said in a news
release. Treatment should begin 12 weeks before the start of
ragweed season -- which in the United States includes late summer
and early fall -- and continue through the season.
The product is placed under the tongue, where it rapidly
dissolves. The first dose should be given by a doctor, who can
monitor the user for any adverse reaction, the FDA said. Subsequent
doses can be taken at home.
Ragwitek's safety and effectiveness were evaluated in clinical
studies involving some 1,700 adults. The most common side effects
included throat irritation and itching of the mouth and ears.
The product's label will include a boxed warning that it could
cause a life-threatening reaction among people who are severely
allergic to the pollen of short ragweed, one of the most common
Ragwitek is produced for New Jersey-based Merck and Co. by
Catalent Pharma Solutions, based in the United Kingdom.
Visit the FDA to learn more about
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