FDA Approves OTC Sale of Prilosec
NEW YORK - The Food and Drug Administration on Friday approved over-the-counter sales of the popular heartburn drug Prilosec, opening the way for a planned fall launch of the drug by Procter & Gamble Co., the company announced. P&G has branded the drug Prilosec OTC.
The approval comes after P&G, which holds the over-the-counter rights to the drug, made changes to the labeling on the box at FDA's request, so consumers could better understand dosage instructions.
Prilosec enters the $1.2 billion over-the-counter U.S. acid relief market where acid-reducer Pepcid is currently the market leader. It will come in the form of 20 mg tablets, the most commonly prescribed strength of the drug.
P&G has an agreement to market the drug over the counter with the drug's maker, AstraZeneca Plc, and has said it expects to sell $200 million to $400 million in the first year the drug is available over the counter.
The approval comes after P&G, which holds the over-the-counter rights to the drug, made changes to the labeling on the box at FDA's request, so consumers could better understand dosage instructions.
Prilosec enters the $1.2 billion over-the-counter U.S. acid relief market where acid-reducer Pepcid is currently the market leader. It will come in the form of 20 mg tablets, the most commonly prescribed strength of the drug.
P&G has an agreement to market the drug over the counter with the drug's maker, AstraZeneca Plc, and has said it expects to sell $200 million to $400 million in the first year the drug is available over the counter.