Sun Pharma receives FDA approval for generic Tiazac ANDA

Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE:SUNPHARMA, BSE: 524715) announced that USFDA has granted its subsidiary an approval for its Abbreviated New Drug Application (ANDA) to market a generic version of once-a-day Tiazac^® extended release capsules.

These generic Tiazac capsules contain Diltiazem Hydrochloride Extended-release USP, 120 mg, 180 mg, 240 mg,300 mg and 360 mg, and are therapeutically equivalent to Biovail Corporation's Tiazac ^® extended release capsules.

Generic Tiazac^® Capsules are indicated for the treatment of hypertension, used alone or in combination with other antihypertensive medications. Generic Tiazac^® Capsules are also used in the treatment of Chronic stable angina.

Extended release Diltaizem Hydrochloride USP capsules have annual sales of approximately $ 46 million in the US.