Ranbaxy Laboratories Limited (RLL), has received final approval from the US Food and Drug Administration (FDA) to manufacture and market amlodipine besylate tablets, 2.5 mg, 5 mg and 10 mg.
The office of generic Drugs, US 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 (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. Amlodipine besylate tablets are 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 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's continued focus on R&D has resulted in several approvals in developed markets and significant progress in new drug discovery. The company's foray into novel drug delivery systems has led to proprietary "platform technologies", resulting in a number of products under development. The company is serving its customers in over 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 49 countries and manufacturing operations in 11 countries.