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FDA approves over-the-counter status for the antihistamine claritin. (Allergic Rhinitis).
The Food and Drug Administration has approved a change to over-the-counter status for the antihistamine Claritin (loratadine) for treatment of the symptoms of allergic rhinitis.
Manufactured by Schering-Plough, the antihistamine was slated to become available to consumers in mid-December 2002 at about the same time that the company's patent on Claritin expired.
"By making it easier to get this widely used drug, today's action will enable many people to get less-sedating, effective relief for their allergy symptoms more quickly and at a lower cost," FDA Commissioner Mark B. McClellan said in a statement.
Claritin is the first nonsedating antihistamine to change to over-the-counter (OTC) status. OTC antihistamines that are already on the market carry warnings restricting use while driving or operating machinery Claritin does not carry a drowsiness warning or restrictions on use while driving.
Claritin is being offered at its original prescription strength, and is available in five formulations. The once-daily formulations include tablets, syrup, orally ...
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Source: HighBeam Research, FDA approves over-the-counter status for the antihistamine claritin....