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Johnson & Johnson-Merck Receives FDA Approval for Pepcid Complete, A Unique New Way To Treat Heartburn
Oct 16, 2000
Johnson & Johnson-Merck Receives FDA Approval for Pepcid Complete, A Unique New Way To Treat Heartburn FT. WASHINGTON, Pa., Oct. 16 -- The U.S. Food and Drug Administration today approved for marketing Pepcid® Complete, a new way to treat heartburn and acid indigestion for the approximate 100 million consumers who suffer from these problems. Pepcid Complete is the first and only non- prescription, combination heartburn tablet developed specifically to safely and effectively stop acid indigestion fast and deliver long-lasting relief in a single tablet.

Pepcid Complete marks the most important advance in the non-prescription heartburn remedy category since 1995, when Pepcid® AC became the first acid reducer (technically known as an H2 antagonist) to be available over-the-counter.

Pepcid Complete's patented dual-action formula combines two medicines to relieve heartburn in two ways. The Pepcid Complete formula consists of a fast-acting chewable antacid (800 mg. calcium carbonate and 165 mg. magnesium hydroxide) that starts to neutralize acid on contact, and the acid-controlling power of Pepcid® AC (10 mg. famotidine) to prevent the production of excess acid at the source while continuing to control acid for up to 12 hours.

"Pepcid Complete is the culmination of a five-year clinical development program to identify a heartburn compound that works fast and keeps symptoms from coming back," said Scott Korn, M.D., F.A.C.P., Senior Director Worldwide OTC Development, Johnson & Johnson-Merck Consumer Pharmaceuticals Company. "Until now, sufferers have had to manage a variety of medicines to relieve their symptoms, choosing speed or duration of relief." Research shows that many of the 100 million Americans suffering from heartburn use more than one product to get relief. "Now there's no trade off. With Pepcid Complete, consumers have the best of both worlds -- rapid and long lasting relief in one single tablet," continued Dr. Korn.

"Antacids alone only neutralize stomach acid temporarily and acid controllers can take a while to start working," explains Michael Wolfe, M.D., Chief of the Gastroenterology Section at Boston University Medical Center, Boston Medical Center and Boston University School of Medicine. "Nothing is faster at controlling acid than Pepcid Complete. In addition, no other heartburn remedy has more strength to keep heartburn and acid indigestion from coming back."

Pepcid Complete will compete in the over-the-counter heartburn remedy category, which is currently valued at $1.4 billion. In 1995, Pepcid® AC created a new acid relief category; today worth over $560 million, and Pepcid® AC remains the category market leader in dollar sales.

Pepcid Complete will be available soon in packages of 5, 15, 25 and 50 chewable tablets at retail food stores, pharmacies and mass merchandisers nationwide. The new tablets have a cool mint flavor and quickly dissolve as they are chewed. A national promotion and advertising campaign will support the introduction of Pepcid Complete. The Pepcid® AC family of brands will continue to be available in original tablet, chewable and gelcap forms.

Pepcid Complete is the most recent new product from Johnson & Johnson- Merck Consumer Pharmaceuticals Co., a joint venture between two of the nation's largest healthcare companies. The company combines the clinical research and development capabilities of Merck & Co., with the consumer marketing and sales expertise of Johnson & Johnson. The company is based in Fort Washington, Pennsylvania.

PEPCID® COMPLETE

FACT SHEET

PRODUCT DESCRIPTION

PEPCID® COMPLETE, marketed by Johnson & Johnson-Merck Consumer Pharmaceuticals Co., offers a unique new way to treat heartburn. Pepcid Complete is the first and only single tablet for heartburn relief that works on heartburn in two different ways. The patented Dual Action formula features a fast-acting antacid that neutralizes acid on contact and the power of Pepcid® AC to prevent the production of excess acid at the source for up to 12 hours.

PEPCID® COMPLETE'S patented Dual Action formulation includes 800 mg of calcium carbonate and 165 mg of magnesium hydroxide, active ingredients in antacids, and 10 mg of famotidine, the active ingredient in PEPCID® AC.

PRODUCT BENEFITS

Only PEPCID® COMPLETE provides a unique heartburn solution. It's the only heartburn product that combines the speed of antacids and the long lasting power of acid reducers in a single tablet.

One PEPCID® COMPLETE chewable tablet begins to neutralize acid immediately and controls acid for up to 12 hours.

Clinical studies document that nothing is faster at controlling acid and that no other non-prescription heartburn remedy has more strength to keep heartburn and acid indigestion from coming back.

PEPCID® COMPLETE meets the unmet need in the marketplace. Research shows that many of the approximate 100 million Americans suffering from heartburn use more than one product to get relief, choosing speed or duration of relief. This occurs because while antacids act fast, relief doesn't last, and while acid reducers last for hours they can take a while to start working. Now there's no trade off, there's Pepcid® Complete.

With PEPCID® COMPLETE, consumers have the best of both worlds - rapid and long lasting relief in one single tablet. No non-prescription medication for heartburn is more effective than Pepcid® Complete. In fact, of the available non-prescription heartburn relievers, nothing has been proven to work faster or last longer.

PEPCID® COMPLETE is available in individually wrapped, easy-to-open packets as well as uniquely designed bottles.

PEPCID® COMPLETE offers consumers one solution for their heartburn, plus convenience and portability.

MECHANISM OF ACTION

PEPCID® COMPLETE's superior Dual Action formula stops heartburn and acid indigestion in two different ways: a fast-acting antacid, like Mylanta®, that neutralizes acid on contact and the acid controlling power of Pepcid ® AC to prevent the production of excess acid at the source. Antacids alone only neutralize stomach acid temporarily, while acid reducers can take a while to start working. PEPCID® COMPLETE provides both speed and strength to treat heartburn and acid indigestion and keeps it from coming back.

AVAILABILITY

PEPCID® COMPLETE will be available in packages of 5, 15, 25 and 50 chewable tablets at retail food stores, pharmacies and mass merchandisers nationwide.

PEPCID® COMPLETE features the easy-to-read labeling developed by Johnson & Johnson-Merck in conjunction with the Food and Drug Administration (FDA).

PEPCID® COMPLETE packaging and promotional materials feature a toll-free 800 number for consumers to call with questions about PEPCID® COMPLETE or to receive a free brochure.

For more information on PEPCID® COMPLETE, refer to the product insert, or call 1-800-755-4008.

PEPCID® COMPLETE is the most recent addition to the Pepcid AC family of products including PEPCID® AC TABLETS, PEPCID® AC CHEWABLES and PEPCID® AC GELCAPS SOURCE Johnson & Johnson-Merck Consumer Pharmaceuticals Company



CONTACT: Jerri Ann Yznaga of The Rowland Company, 212-527-8884; or Pat Donohue of Johnson & Johnson-Merck Consumer Pharmaceuticals Co., 215-273-7809

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