To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: TAP Pharmaceutical Products Receives FDA Approval for Pediatric Labeling Of Prevacid (Lansoprazole) URL: http://www.pslgroup.com/dg/21A56E.htm Doctor's Guide August 5, 2002
- #1 Prescribed Proton Pump Inhibitor Now Approved for Pediatric GERD - LAKE FOREST, IL -- August 5, 2002 -- TAP Pharmaceutical Products Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Prevacid® (lansoprazole) for the short-term treatment of symptomatic gastroesophageal reflux disease (GERD) and erosive esophagitis in children from the ages of 1 to 11 years old. Currently, Prevacid is the most prescribed* proton pump inhibitor (PPI) in the United States. "Although people often think of GERD as an adult condition, many children are affected by it," said Benjamin Gold, M.D., director of pediatric gastroenterology and nutrition at Emory University School of Medicine. "It is important that there are FDA-approved treatment options for children who experience the often painful effects of GERD." GERD is one of the most common esophageal disorders in children. When stomach contents, such as food and gastric acid, frequently reflux out of the stomach and into the esophagus, esophageal tissue damage may occur. Common symptoms in children include regurgitation (spitting up), chest pain (heartburn), abdominal pain, feeding resistance and difficulty swallowing. "The symptoms of GERD are uncomfortable for children, and can be disruptive for both the child and his or her family," said Beth Anderson, executive director of the Pediatric/Adolescent Gastroesophageal Reflux Association. "We encourage parents who suspect their child may be suffering from GERD to approach their doctor and discuss symptoms, diagnosis and treatment options." For children who have difficulty swallowing capsules, Prevacid is the only PPI with an oral suspension formulation. The oral suspension is strawberry-flavored. Additionally, the granules from a Prevacid capsule can be sprinkled on certain soft foods and mixed into select juices. Granules should not be chewed or crushed and the oral suspension should not be given through a feeding tube. Prevacid has the most administration options and the most approved indications of any PPI for adults. It is the only PPI indicated for the healing and risk reduction of the recurrence of gastric (stomach) ulcers associated with NSAIDs (non-steroidal anti-inflammatory drugs). TAP also has submitted an application with the FDA for a Prevacid orally disintegrating tablet. About Prevacid(R) (lansoprazole) In adults, Prevacid is indicated for the treatment of heartburn and other symptoms of GERD; the treatment and maintenance of erosive esophagitis, a condition in which stomach acid injures the lining of the esophagus; treatment of active benign gastric (stomach) ulcers; the treatment and maintenance of healed duodenal ulcers (ulcers found on the first part of the small intestine); treatment of pathological hypersecretory conditions (which involve the overproduction of stomach acid), including Zollinger-Ellison Syndrome; and the healing and risk reduction of the recurrence of gastric ulcers associated with NSAIDs. Symptomatic response to therapy does not preclude the presence of serious stomach problems. Prevacid is contraindicated in patients with known hypersensitivity to any component of the formulation. The most frequently reported adverse events in adults include diarrhea, abdominal pain, and nausea. In pediatric GERD patients between the ages of 1 to 11, the most frequently reported adverse events were constipation and headache. For further information on Prevacid, please see the complete prescribing information and visit http://www.prevacid.com . About TAP Pharmaceutical Products Inc. TAP Pharmaceutical Products Inc., located in Lake Forest, Ill., is a joint venture between Abbott Laboratories (NYSE: ABT), headquartered in Abbott Park, Ill., and Takeda Chemical Industries, Ltd., of Osaka, Japan. TAP also markets Lupron Depot® (leuprolide acetate for depot suspension) and SPECTRACEFTM (cefditoren pivoxil). For more information about TAP Pharmaceutical Products Inc., and its products, visit the company's Web site at http://www.tap.com . *IMS HEALTH, National Prescription Audit Plus 7 Weekly™, April 2002. SOURCE: Abbott Laboratories --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. 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