FDA Approves Prevacid 24HR for OTC Market

BASEL, Switzerland — Novartis here announced last week it won over-the-counter approval from the U.S. Food and Drug Administration for Proton Pump Inhibitor Prevacid 24HR (lansoprazole delayed-release capsules 15 mg).

This is the first OTC PPI treatment of frequent heartburn since 2003, the company said in a statement.

Prescription-strength Prevacid 24HR treats frequent heartburn for a full 24 hours. Used once daily, Prevacid 24HR works by stopping the release of acid into the stomach.

The drug achieved $3.37 billion in annual sales in the U.S. in 2008. It is expected to be available OTC sometime this year.

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