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Lupin launches generic Activella Tablets in the US

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These tablets are indicated in a woman with a uterus for treatment of moderate to severe vasomotor symptoms due to menopause and prevention of postmenopausal osteoporosis

Lupin’s US subsidiary, Lupin Pharmaceuticals 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 (FDA) 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).

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 $91.1 million (IMS MAT June 2016).

EP News Bureau

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