Sun Pharma Announces USFDA Tentative Approval for Generic Strattera® Capsules

Mumbai, Maharashtra, India, Thursday, November 26, 2009 -- (Business Wire India)

Sun Pharma announced that the USFDA has granted a tentative approval for an Abbreviated New Drug Application (ANDA) for generic Strattera®, atomoxetine hydrochloride capsules.

These atomoxetine hydrochloride capsules, therapeutically equivalent to Strattera® capsules from Eli Lilly, are available in seven strengths viz. 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg. Atomoxetine hydrochloride capsules have annual sales of approximately USD 500 million in the US.

Strattera® capsules are indicated for the treatment of attention deficit hyperactivity disorder.

Strattera® is a registered trademark of Eli Lilly and Company.

About Sun Pharmaceutical Industries Ltd.

Established in 1983, listed since 1994 and headquartered in India, Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) 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. More information about the company can be found at www.sunpharma.com.