Ranbaxy gets FDA tentaive approval for Amlodipine

Mumbai, June 20 (UNI) Pharma major Ranbaxy Laboratories today announced it has received tentative approval from the US Food and Drug Administration (FDA) to manufacture and market Amlodipine Besylate tablets, which is indicated for the treatment of hypertension.

Ranbaxy will manufacture and market the tablets in the base range of 2.5 mg, 5 mg and 10 mg. The total annual market sales for Norvasc, Amlodipine Besylate Tablets were USD 2.79 billion, the company said in a statement today.

According to the company, besides being indicated for the treatment of hypertension, Amlodipine Besylate tablets have multi use in medicine. It 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.

UNI