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news.Ranbaxy Pharmaceuticals has received tentative approval from the FDA to manufacture and market amlodipine besylate tablets for the treatment of hypertension.
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The company will manufacture 2.5 mg (base), 5 mg (base) and 10 mg (base) tablets, which can be used alone or in combination with other antihypertensive agents.
Amlodipine besylate is also indicated for the symptomatic treatment of chronic stable angina and may be used alone or in combination with other antianginal agents. The product is also indicated for the treatment of confirmed or suspected vasospastic angina and may be used as monotherapy or in combination with other antianginal drugs.
Commenting on the approval, Jim Meehan, vice president of sales and marketing for RPI, said, “this product represents a future opportunity for Ranbaxy and will be launched following final approval from the FDA. This product will further expand our product portfolio of affordable generic alternatives.”
Ranbaxy Pharmaceuticals, based in Jacksonville, Florida, is a wholly owned subsidiary of Ranbaxy Laboratories, India’s largest pharmaceutical company.