Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), has announced that RLL has received final approval from the U.S. Food and Drug Administration 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(R) of Pfizer Pharmaceuticals Inc. Total annual market sales for Norvasc(R), 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.