Merck’s Pepcid (famotidine)
Executive Summary
Approved Dec. 10 for "short-term treatment of patients with symptoms" of gastroesophageal reflux disease (GERD) and for "short- term treatment of esophagitis due to GERD, including erosive or ulcerative disease diagnosed by endoscopy." SmithKline Beecham's Tagamet (cimetidine) is indicated for "erosive esophagitis diagnosed by endoscopy" with treatment indicated for "12 weeks for healing of lesion and control of symptoms." Glaxo's Zantac (ranitidine) is indicated for the treatment of GERD with "symptomatic relief commonly" occurring one or two weeks after therapy commences. Pepcid's dosage for GERD is 20 mg b.i.d for up to six weeks. For patients with esophagitis and accompanying GERD symptoms, dosing is "20 or 40 mg b.i.d. for up to 12 weeks." Merck filed for the supplemental indication on May 24, 1989....