Ranbaxy anti-hypertensive gets USFDA nod

Ranbaxy Laboratories has received final approval from the US 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, 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. 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 anti-hypertensive agents. Amlodipine Besylate is also indicated for the symptomatic treatment of chronic stable angina and may be used alone or in combination with other anti-anginal 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 anti-anginal 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," Jim Meehan, VP (sales & marketing) RPI, USA.