WASHINGTON The Food and Drug Administration has approved an application by Dr. Reddy’s for rantidine 150 mg tablets, Zantac’s generic over-the-counter equivalent.
“We are excited about the Ranitidine 150mg approval as it will complement our Ranitidine 75mg OTC entry. This approval will help establish Dr. Reddy’s in the U.S. OTC business segment. The company has plans to expand its OTC product portfolio and additional introductions are planned in the coming months that will certainly include Rx switches and select OTC Monograph products,” said Mark Hartman, president of North America Generics.
The company will distribute the 150mg tablet in blister counts of 8 and 24’s as well as bottles of 50, 65 and 95 counts.