FDA clears new labeling for Prilosec reflecting long-term safety data.WAYNE, Pa.--(BUSINESS WIRE)--March 13, 1995--Astra Merck Inc. has received clearance from the Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) to revise the labeling for the anti-secretory drug Prilosec (omeprazole) following review of data resolving previous questions about long-term safety. Late last year the company presented to the FDA Gastrointestinal Drugs Advisory Committee data demonstrating the relative safety of Prilosec in clinical studies of up to eight years, as well as experience with millions of patients worldwide since the drug was first marketed. "This is a significant decision for the medical community, since Prilosec is already the most widely prescribed anti-secretory drug among gastroenterologists in the United States and works uniquely well for many patients who suffer from peptic associated diseases," said Irwin Scher, MD, Astra Merck's vice president for drug development and medical affairs. "As a result of this decision, physicians can continue to confidently prescribe Prilosec." Prilosec is indicated for the short-term treatment of symptomatic GERD GERD gastroesophageal reflux disease. GERD abbr. gastroesophageal reflux disease GERD (gastroesophageal reflux disease gastroesophageal reflux disease (GERD) Disorder characterized by frequent passage of gastric contents from the stomach back into the esophagus. Symptoms of GERD may include heartburn, coughing, frequent clearing of the throat, and difficulty in swallowing. ) that is poorly responsive to customary medical treatment, as well as for short-term treatment of active duodenal ulcer duodenal ulcer, n a peptic ulcer located in the duodenum. See also ulcer, peptic. duodenal ulcer An ulcer of the duodenum Epidemiology H pylori and erosive e·ro·sive adj. Causing erosion. esophagitis esophagitis /esoph·a·gi·tis/ (e-sof?ah-ji´tis) inflammation of the esophagus. chronic peptic esophagitis reflux e. . It is also indicated for the long-term treatment of certain pathological hypersecretory conditions. The FDA has recommended the removal of the qualifier "severe" from the erosive esophagitis claim, clearing the way for the unrestricted use of Prilosec in all grades of erosive esophagitis. When Prilosec was first cleared for marketing in 1989, the FDA required that the product's labeling include a notice that more data were needed to rule out the possibility of increased risk from long-term therapy. "The studies and data presented to the FDA advisory committee in December demonstrated the safety of Prilosec in extended use," said Scher. "Removal of the notice regarding long-term use is a consequence of our presentation of these extensive data. The application for maintenance therapy in healed erosive esophagitis is currently under review by the FDA," he added. The first of a new class of anti-secretory compounds known as acid pump inhibitors, Prilosec was discovered by scientists from Astra AB, Sweden's leading pharmaceutical company. It has been marketed in the U.S. since 1989. Astra Merck, previously a unit of Merck & Co., Inc., became America's newest pharmaceutical company on Nov. 1, 1994, when it was reorganized as a separate company, owned equally by Merck and Astra. In addition to Prilosec, the company markets the cardiovascular drugs Plendil (felodipine) and Tonocard (tocainide HCL tocainide HCl (tōkā´nīd), n brand name: Tonocard; drug class: antidysrhythmic (Class IB), lidocaine analog; action: ) -0- For a copy of the package insert package insert Pharmacology A synopsis of key physicochemical, pharmacologic, clinical efficacy, and clinical safety properties of a prescription drug, bundled therewith, intended to be highly readable and helpful to clinicians looking for specific , please call 610/695-1230. CONTACT: Astra/Merck Inc., Wayne Roy Walker, 610/695-1559, Home: 215/355-5968 or Fleishman-Hillard, New York New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of Michael Rinaldo, 212/265-9150, Home: 201/440-1521 |
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