MONDAY, Dec. 2, 2002 (HealthDayNews) -- The U.S. Food and Drug Administration has approved the nation's most popular antihistamine, Claritin, for over-the-counter use without a prescription.
The agency says the ground-breaking non-drowsy allergy drug met its three criteria for OTC approval:
- That the drug treats a condition that people can diagnose and manage themselves;
- That the drug is safe enough to be used without a doctor's supervision;
- That the drug's label explains any side effects and contains clear instructions for use.
Claritin received FDA approval in 1993 as one of the first non-drowsy prescription drugs to treat seasonal allergies. In granting over-the-counter approval, the agency also gave manufacturer Schering-Plough the conditional right to market the drug for the treatment of hives, provided some focus-group studies are concluded and subsequent labeling changes are made, the company says. The company's major patent expires Dec. 19, and a number of competitors are planning on introducing their own versions of the drug.
The OTC doses of Claritin, which will match those previously available by prescription, should reach the stores by mid-December, adds Schering-Plough.
Allergies and asthma affect between 20 percent and 30 percent of the nation, experts say, a figure that has doubled in the last 20 years. These conditions lead to as many as 11 million doctor visits a year, along with 2 million trips to the emergency room and a half million hospitalizations. Their economic toll amounts to 30 million missed days of work and school and upwards of $13 billion in direct and indirect costs annually.
Here is the
FDA Talk Paper announcing Claritin's approval for OTC use, and here is the announcement issued by
Schering-Plough. For more information on seasonal allergies, visit the
National Institutes of Health.
