US FDA approves S-P's 'Claritin' for OTC sales

27 November 2002 18:59  [Source: ICIS news]

HOUSTON (CNI)--The US Food & Drug Administration (FDA) said Wednesday it has approved Schering-Plough's allergy drug Claritin (loratadine) for over-the-counter (OTC) sales.

Widely used for treatment of seasonal allergic ailments, Claritin previously has been available only by prescription.

FDA commissioner Mark McClellan said in announcing the OTC approval today: "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."

"This approval," said McClellan, "reflects FDA's commitment to bringing prescription drugs to the OTC market when they can be safely used without a prescription."

The FDA said Claritin met the agency's criteria for OTC sales: the drug must treat a condition consumers can diagnose and manage themselves; the drug is sufficiently safe for use by consumers without direct prescriber supervision; and, the drug's label explains potential adverse effects and conditions with clear directions."

FDA noted too that when drugs move from prescription-only sales to OTC sales, purchase prices for the drug typically decline.

The move to OTC for Claritin, said an FDA statement, also marks a milestone in "offering consumers a potentially safer alternative to currently-available OTC drugs that may contribute to driving impairment." OTC antihistamines already on the market, FDA noted, may cause drowsiness. Many US states prohibit use of automobiles by persons taking such attention-inhibiting allergy and cold treatments.

As much as 30% of the US adult population suffer from seasonal allergy symptoms, the FDA noted.

Claritin was first approved as a prescription drug treatment in April 1993.

Officials at Kenilworth, New Jersey-based Schering-Plough were not immediately available to respond to questions about the OTC approval from the FDA.

By: Joe Kamalick
+1 713 525 2653

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