News
FDA Approves Johnson & Johnson·Merck's Prescription Strength PEPCID® AC (famotidine 20 mg) for Over-The-Counter
Maximum Strength PEPCID® AC Provides a Strong and Effective Treatment Option for the Millions Suffering from Occasional Heartburn
Fort Washington, PA (September 24, 2003) – Johnson & Johnson•Merck Consumer Pharmaceuticals Co. announced today the approval by the U.S. Food and Drug Administration (FDA) of Maximum Strength PEPCID® AC (famotidine 20 mg) for over-the-counter (OTC) usage. The highest famotidine dosing now available without a prescription, Maximum Strength PEPCID® AC is a strong and effective choice for treating heartburn associated with acid indigestion and sour stomach.
"We are extremely pleased with the FDA approval of Maximum Strength PEPCID® AC," said Renaat Van den Hooff, worldwide president, Johnson & Johnson•Merck. "Since our initial Rx to OTC switch in 1995, the PEPCID® Brand has provided a variety of options for heartburn sufferers. We are delighted that we can now offer our prescription strength PEPCID® AC over-the-counter to meet the needs of those heartburn sufferers who require stronger treatment options."
The new Maximum Strength PEPCID® AC patented formula is double the strength (famotidine 20 mg) of Original PEPCID® AC (famotidine 10 mg). Maximum Strength PEPCID® AC will be available in packages of five, 25, 50 and 75 tablets at retail food stores, pharmacies and mass merchandisers nationwide this October. The PEPCID® AC family of products will continue to be available in original tablet, chewable and gel cap formulations.
"This is great news for occasional heartburn sufferers," said Steven R. Peikin, M.D., head of Gastroenterology and Department of Liver Disease at Cooper Hospital/University Medical Center and professor of medicine at Robert Wood Johnson Medical School and author of Gastrointestinal Health. "Maximum Strength PEPCID® AC provides effective prescription strength relief, and continues to offer heartburn sufferers the choice to take a heartburn remedy only when needed."
Heartburn occurs as a result of inappropriate relaxation of the muscular valve at the lower end of the esophagus, or food pipe. This valve normally serves to keep acidic juices in the stomach. Heartburn strikes when acid from the stomach flows up into the esophagus causing a burning sensation in the chest or throat, sometimes leaving a sour or bitter taste in the mouth. Certain foods may trigger heartburn such as coffee, fatty foods, chocolate, peppermint and alcohol. Heartburn can usually be treated and prevented through lifestyle modifications, as well as with medication.
The PEPCID® Franchise has had an important presence in the acid relief category since 1995, and continues to be the choice of millions of consumers. PEPCID® provides effective and long-lasting relief, which lasts all day or all night, only when needed. PEPCID® AC prevents heartburn when taken before meals and PEPCID® Complete's superior Dual Action formula stops heartburn and acid indigestion after it starts. PEPCID® Complete's fast-acting antacid starts neutralizing acid on contact while the H2 blocker, found in PEPCID® AC, prevents the production of excess acid at the source, to provide fast, long-lasting, all day or all night relief* with just one dose.
Maximum Strength PEPCID® AC is the newest product from Johnson & Johnson•Merck Consumer Pharmaceuticals Co., a joint venture between two of the nation's largest health care companies. The company combines the clinical research and development capabilities of Merck and Co., with the consumer marketing and sales expertise of Johnson & Johnson. The company is based in Fort Washington, PA.