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Sun Pharma receives FDA approval for generic Tiazac ANDA

Sun Pharma receives FDA approval for generic Tiazac ANDA

Write: Natale [2011-05-20]

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.

SOURCE Sun Pharmaceutical Industries Ltd.