Sun Pharma Announces USFDA Approval For Generic Wellbutrin SR Extended Release Tablets
Sun Pharmaceutical Industries Ltd. 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 $300M in the US.
Bupropion Hydrochloride (SR) Extended Release tablets are indicated for the treatment of major depressive disorder.
About Sun Pharmaceutical Industries Ltd.
Established in 1983, listed since 1994 and headquartered in India, Sun Pharmaceutical Industries Ltd. is an international, integrated, speciality pharmaceutical company. It 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. In India, the company is a leader in niche therapy areas of psychiatry, neurology, cardiology, diabetology, gastroenterology, and orthopedics. The company has strong skills in product development, process chemistry, and manufacturing of complex API, as well as dosage forms. For more information, visit www.sunpharma.com.
SOURCE: Sun Pharmaceutical Industries Ltd.