FDA Approves Ragwitek for Adult Ragweed Allergy
Tablet placed under the tongue
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 seasonal allergens.
Ragwitek is produced for New Jersey-based Merck and Co. by Catalent Pharma Solutions, based in the United Kingdom.