Sun Pharmaceutical Industries’ arm gets US FDA’s nod for generic Cardizem CD

31 Oct 2011 Evaluate

Sun Pharmaceutical Industries’ subsidiary has been granted a tentative approval from United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) to market a generic version of Cardizem CD, Diltiazem HCL extended release capsules. These Diltiazem HCL extended release capsules are equivalent to Valeant international’s, Cardizem CD, 120mg, 180mg, 240mg, 300mg and 360mg. Annual sale in the US for these strengths is about $300 million.

Diltiazem HCL extended release capsules are indicated in the treatment of hypertension, for the management of chronic stable angina and angina due to coronary artery spasm.

Sun Pharmaceutical Industries manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India, US and several other markets across the world.

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