Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Dr Reddy's has announced FDA final approval for its abbreviated new drug application for ranitidine 150mg tablet, a generic version of GlaxoSmithKline's stomach drug Zantac.
Subscribe to our email newsletter
According to the company, this is the first approval for Dr Reddy's US over-the-counter (OTC) business to launch a Store Brand OTC Division in the US. Ranitidine is commonly used in the treatment of peptic ulcer disease and gastroesophageal reflux disease.
Mark Hartman, president, North America Generics, said: “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 US OTC business segment.”
The company has plans to expand its OTC product portfolio and additional introductions are planned in the coming months that will include Rx switches and select OTC Monograph products.
The company will distribute the 150mg strength in blister counts of eight and 24's as well as bottles of 50, 65 and 95 counts.