New Delhi: Pharma major, Dr Reddy’s Laboratory, said on 13 September it has got the approval of US Food and Drug Administration (USFDA)for the company’s Abbreviated New Drug Application (ANDA) for Ranitidine (Zantac) tablet in 150 mg strength, used in the treatment of Stomach and duodenal ulcers.
Dr Reddy’s Laboratory is the only generic manufacturer to receive FDA approval for this product and is also the first approval for the company’s US Over The Counter (OTC) drug business.
“We are excited about the Ranitidine approval as it would help in establishing Dr Reddy’s in US OTC business segment. The company has plans to expand its OTC product portfolio and additional introductions are planned in the coming months,” North America Generics president Mark Hartman said in a statement.
Dr Reddy’s had, earlier in May, announced its plans to launch store brand OTC Division in the US and the company already had the USFDA nod for the tablet in 75 mg strength.