Lupin receives US FDA nod for generic Activella tablet

Pharma major Lupin Limited yesterday announced that it has received final approval from the US Food and Drug Administration (FDA) for its Amabelz tablet (estradiol and norethindrone acetate tablets 0.5 mg / 0.1 mg and 1 mg / 0.5 mg). Lupin’s Amabelz is the AB rated generic equivalent of Amneal Pharmaceuticals’ Activella tablet, which had US sales of $ 95.6 million as per IMS MAT March 2016.
 
Amabelz tablet is indicated in a woman with a uterus for treatment of moderate to severe vasomotor symptoms due to menopause and prevention of postmenopausal osteoporosis. Amabelz tablet (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.