Ranbaxy Laboratories receives final US FDA approval to manufacture and market Amlodipine Besylate Tablets

Ranbaxy Laboratories Ltd, on July 10, 2007 has announced that the Company has received final approval from the U.S. Food and Drug Administration (FDA) to manufacture and market Amlodipine Besylate Tablets, 2.5 mg (base), 5 mg (base) and 10 mg (base). The Office of Generic Drugs, U.S. Food and Drug Administration, has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Norvasc Tablets® of Pfizer Pharmaceuticals Inc. 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. Amlodipine Besylate Tablets are also indicated for the treatment of confirmed or suspected vasospastic angina and may he used as monotherapy or in combination with other antianginal drugs.

"We are pleased to receive this final FDA approval for Amlodipine Besylate Tablets, which represents Ranbaxy's 115th ANDA approval to date. This product will further expand our product portfolio of affordable generic alternatives and will be launched in August 2007 to all classes of trade," said Jim Meehan, Vice President of Sales and Marketing for 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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