USFDA approves Sun Pharmaceutical Industries' ANDA for generic Wellbutrin SR Extended Release tablets

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Apr 8 2010

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 GlaxoSmithKline's Wellbutrin SR® Extended Release tablets.

These generic Bupropion Hydrochloride Extended Release tablets are equivalent to GlaxoSmithKline's Wellbutrin SR® Extended Release tablets and includes three strengths: 100 mg, 150 mg and 200 mg. These strengths of generic Bupropion Hydrochloride Extended Release tablets have a combined annual sale of approximately $ 300 million in the US.

Bupropion Hydrochloride (SR) Extended Release tablets are indicated for the treatment of major depressive disorder.

Source:

 Sun Pharmaceutical Industries Ltd.

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