Ranbaxy receives Tentative Approval from US FDA to manufacture & market Amlodipine Besylate Tablets

Ranbaxy Laboratories Ltd, on June 20, 2007 has announced that the Company has received tentative approval from the US Food and Drug Administration to manufacture and market Amlodipine Besylate Tablets, 2.5 mg (base), 5 mg (base) and 10 mg (base). Total annual market sales for Norvasc®, Amlodipine Besylate Tablets were $2.79 billion (IMS - MAT: March 2007).

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 he 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.

Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida, USA, is a wholly owned subsidiary of the Company. RPI is engaged in the sale and distribution of generic and branded prescription products in the U.S. healthcare system.

Source : Equity Bulls

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