Executive Summary

FDA clears ANDA suitability petition for new dosage form of famotidine 10 mg (J&J/Merck's Pepcid AC) in Nov. 30 letter to Budd Lake, N.J.-based regulatory analyst Thomas Blake. He filed the suitability petition on behalf of an unnamed client Sept. 12, 1997 along with petitions for a two-tablet dose of 5 mg effervescent famotidine and two-tablet effervescent ranitidine containing 37.5 mg per tablet (75 mg total dose, equivalent to Warner-Lambert's Zantac 75) ("The Tan Sheet" Sept. 29, 1997, In Brief). The ranitidine petition was withdrawn after FDA approved Zantac Efferdose Feb. 26 ("The Tan Sheet" March 2, p. 1)