Dr Reddy's Gets Final FDA Nod For Ranitidine 150mg Tabs

New Delhi: Dr Reddy’s Laboratories (DRL) has received final approval for its Abbreviated New Drug Application (ANDA) for Ranitidine 150mg pill by the US Food and Drug Administration (FDA)

DRL is the only generic maker to get FDA authorization for this Abbreviated New Drug Application (ANDA) product accompanying the expiry of innovator's patents.

According to a statement, the company will distribute the 150 mg potency in blister counts of 8 and 24’s plus bottles of 50, 65 and 95 counts.

This is the first commendation for the company’s US OTC business division abiding by an announcement in mid-May, to launch a store brand OTC section in the United States.

Company's President (North America Generics) Mark Hartman 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 also plans to amplify its OTC product range and added introductions are projected in the coming future, which will certainly comprise Rx switches and select OTC Monograph products.

"The shipments have already started. The results will appear in financials in this quarter itself and the rest of the year," said GV Prasad, Vice Chairman & CEO, DRL.

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