Ranbaxy Laboratories Ltd (RLL) has received tentative approval from the US Food and Drug Administration (FDA) to manufacture and market amlodipine besylate tablets, 2.5 mg, 5 mg and 10 mg. Total annual market sales for Norvasc, amlodipine besylate tablets were $2.79 billion.
Amlodipine besylate tablets are indicated for the treatment of hypertension and may 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.
"We are pleased to receive this tentative approval for amlodipine besylate tablets. 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," said Jim Meehan, vice president of sales and marketing for Ranbaxy Pharmaceuticals Inc (RPI), USA.