Lupin launches Activella generic in US

After receiving an approval from the US Food and Drug Administration (FDA), Lupin Limited has launched its Amabelz (estradiol and norethindrone acetate) tablets in two strengthens - 0.5 mg / 0.1 mg and 1 mg / 0.5 mg – in the US. Amabelz is the generic equivalent of Amneal Pharmaceuticals’ Activella tablet.

Amabelz 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. The tablet in strengthen of 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, according to IMS MAT June 2016.