Lupin has received final approval for its Amabelz Tablets (Estradiol and Norethindrone Acetate Tablets USP, 0.5 mg/0.1 mg and 1mg/0.5 mg) from the United States Food and Drug Administration (USFDA) 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). As per IMS MAT March 2016, Activella had US sales of $95.6 million.
Lupin’s Amabelz Tablets (Estradiol and Norethindrone Acetate Tablets USP, 0.5 mg / 0.1 mg and 1 mg / 0.5mg) 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.
Lupin 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.
