Lupin’s US subsidiary - Lupin Pharmaceuticals, Inc. has launched its Amabelz Tablets (Estradiol and Norethindrone Acetate Tablets USP, 0.5 mg / 0.1 mg and 1 mg / 0.5 mg) having received an approval from the United States Food and Drug Administration (USFDA) earlier 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). As per IMS MAT June 2016, Activella had US sales of $91.1 million.
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.
