Sun Pharma gets USFDA nod for generic cardiac capsules
New Delhi: Drug maker Sun Pharmaceutical on Monday said it has received approval from the US health regulator to market generic Diltiazem HCl extended-release capsules used for treating hypertension and angina in the American market.
The company's subsidiary has been granted approval by the United States Food and Drug Administration (USFDA) for the abbreviated new drug application (ANDA) to market generic Diltiazem HCl extended-release capsules, Sun Pharma said in a statement.
These Diltiazem HCl extended release capsules are generic equivalent to Valeant International's Cardizem CD capsules in the strengths of 20 mg, 180 mg, 240 mg, 300 mg and 360 mg, it added.
The company said that, "annual sale in the US for these strengths is approximately USD 300 million".
Diltiazem HCl extended-release capsules are indicated for the treatment of hypertension and for the management of angina.
Shares of Sun Pharmaceutical Industries today closed at Rs 503.30 on BSE, down 1.08 percent from its previous close.