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Ranbaxy gets FDA nod for anti-diabetic drug
Mumbai, Sept 12: Ranbaxy Laboratories, India`s largest pharmaceutical company, announced on its Web site on Friday that it had received US Federal Drug and Administration approval for manufacturing and selling anti-diabetic drug Metformin HCl Oral Solution 100 mg/mL under the brand name `Riomet`.
Mumbai, Sept 12: Ranbaxy Laboratories, India's largest pharmaceutical company, announced on its Web site on Friday that it had received US Federal Drug and Administration approval for manufacturing and selling anti-diabetic drug Metformin HCl Oral Solution 100 mg/mL under the brand name ‘Riomet’.
Riomet will be marketed and distributed by the Brand Products Division of Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy.
Ranbaxy developed the drug under the new drug application and has received the US Food and Drug Administration approval within 11 months of filing, a report said.
The nod is for an oral solution. This New Drug Application provides for the use of Riomet (Metformin HCl) as monotherapy as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.
Ranbaxy is focusing on selling its pharmaceutical products in the US, where medicines worth $35 billion lose patent protection between 2000 and 2005. The company already sells more than 55 drugs in the US.
Bureau Report