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Lupin Receives FDA Approval for Generic Activella® Tablets

 

Mumbai, Baltimore, June 22, 2016: Pharma Major Lupin Limited (Lupin) announced today that it has received final approval for its Amabelz™ Tablets (Estradiol and Norethindrone Acetate Tablets USP, 0.5 mg / 0.1 mg and 1 mg / 0.5 mg) from the United States Food and Drug Administration (FDA) to market a generic version of Amneal Pharmaceuticals’ Activella® Tablets (Estradiol and Norethindrone Acetate Tablets USP, 0.5 mg / 0.1 mg and 1 mg / 0.5 mg).

Lupin’s Amabelz™ Tablets (Estradiol and Norethindrone Acetate Tablets USP, 0.5 mg / 0.1 mg and 1 mg / 0.5 mg) are the AB rated generic equivalent of Amneal Pharmaceuticals’ Activella® Tablets (Estradiol and Norethindrone Acetate Tablets USP, 0.5 mg / 0.1 mg and 1 mg / 0.5 mg).

Amabelz™ Tablets 0.5 mg / 0.1 mg and 1 mg / 0.5 mg are indicated in a woman with a uterus for treatment of moderate to severe vasomotor symptoms due to menopause and prevention of postmenopausal osteoporosis.

Amabelz™ Tablets 1 mg / 0.5 mg is also indicated in a woman with a uterus for treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause.

Activella® had US sales of USD 95.6 million (IMS MAT March 2016).

About Lupin Limited

Headquartered in Mumbai, Lupin is an innovation led transnational pharmaceutical company producing and developing a wide range of branded & generic formulations, biotechnology products and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership positions in the Anti-TB and Cephalosporin segment.

Lupin is the 5th largest and fastest growing top 10 generics player in the US (5.51% market share by prescriptions, IMS Health) and the 3rd largest Indian pharmaceutical company by sales globally. The Company is also the fastest growing top 10 generic pharmaceutical players in Japan (ranked 9th) and South Africa (ranked 4th – IMS Health).

For the financial year ended 31st March 2016, Lupin’s Consolidated turnover and Profit after Tax were Rs. 137,016 million (USD 2.09 billion) and Rs. 22,707 million (USD 347 million) respectively. Please visit http://www.lupin.com for more information. You could also follow us on Twitter – www.twitter.com/lupinlimited

CIN: L24100MH1983PLC029442 Registered Office: Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai – 400 055.

For further information or queries please contact –

Shamsher Gorawara
Head – Corporate Communications
Ph: +91-98 20 338 555
Email: shamshergorawara@lupin.com

*Safe Harbor Statement

Activella® is the registered trademark of Novo Nordisk Health Care AG.