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news.The FDA is to allow Indian pharmaceutical company Ranbaxy Laboratories to manufacture and market its anti-diabetic metformin extended release tablets in 750 mg dosage.
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The FDA has found that Ranbaxy’s formulation has the same therapeutic effect as that of Glucophage, developed by New York-based Bristol-Myers Squibb.
According to the company, metformin hydrochloride extended release tablets are designed to be taken in addition with diet and exercise in order to improve glycemic control in patients with type 2 diabetes. The tablets are indicated in patients older than 17 and can be used with a sulfonylurea or insulin to improve glycemic control.
“This is a wonderful opportunity for Ranbaxy to introduce another affordable generic alternative to the U.S. healthcare system. It also marks a major milestone as the 100th ANDA approval held by RLL allowing us to market another ethical product under the Ranbaxy label in the U.S. Our plans are to introduce this product when quantities are sufficient to support market demand,” said Jim Meehan, Vice President of Sales and Marketing for Ranbaxy Pharmaceuticals, USA.