New Delhi, July 4
RANBAXY Laboratories Ltd (RLL) has reached a landmark of sorts by receiving its 100th abbreviated new drug approval (ANDA) from the US Food and Drug Administration (FDA) for its anti-diabetic drug, Metformin Hydrochloride extended-release tablets, 750 mg.
Ranbaxy's formulation has the same therapeutic effect as that of Bristol-Myers Squibb's Glucophage. The total annual market sales for Metformin tablets were $227 million with market sales of 750 mg version of the drug having registering sales of $29.0 million.
Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in patients with Type-2 diabetes.
In a statement, Mr Jim Meehan, Vice-President of Sales and Marketing for Ranbaxy Pharmaceuticals Inc, said, "This is a wonderful opportunity for Ranbaxy to introduce another affordable generic alternative to the US healthcare system. It also marks a major milestone as the 100th ANDA approval held by the company allowing us to market another ethical product under the Ranbaxy label in the US. Our plans are to introduce this product when quantities are sufficient to support market demand."