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FDA Approves Over-The-Counter Claritin (Loratadine)

BETHESDA, MD -- December 2, 2002 -- FDA has approved Claritin (loratadine) as an over-the-counter (OTC) allergy drug product. Previously available only as a prescription drug, Claritin is approved for seasonal allergic rhinitis -- a condition that causes runny nose, nasal congestion, sneezing, and itchy nose, throat, eyes, and ears.

"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," said Mark B. McClellan, M.D., Ph.D., Commissioner of Food and Drugs. "This approval reflects FDA's commitment to bringing prescription drugs to the over-the-counter market when they can be safely used without a prescription."

Claritin's approval for OTC marketing was based on FDA's criteria for determining appropriate drugs for OTC use - namely that the drug in question treats a condition that consumers can diagnose and manage themselves; that the drug is sufficiently safe for use by consumers without direct prescriber supervision; and that the drug's label explains potential adverse effects and conditions of use with clear and understandable directions. When drugs move from prescription to OTC status the price typically declines.

Today's action also marks a milestone in FDA's work with the National Transportation Safety Board to improve public awareness of the concerns about possible impairment caused by certain prescription and OTC drug products that cause drowsiness. Because OTC antihistamines already on the market may cause drowsiness, the FDA requires them to carry warnings about using them while driving or operating machinery. This new approval offers many consumers a potentially safer alternative to currently-available OTC drugs that may contribute to driving impairment.

Approximately 10 to 30 percent of adults in the United States suffer from seasonal allergy symptoms. In April 1993, Claritin was approved as one of the first new generation antihistamines developed to be less sedating than traditional antihistamines.

Claritin is manufactured by Schering-Plough based in Kenilworth, N.J.

SOURCE: FDA

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