FDA approves Minivelle for Menopause/Osteoporosis - Noven Pharma

The FDA has approved a new indication with a new dose of Minivelle (estradiol transdermal system), from Noven Pharma, for the prevention of postmenopausal Osteoporosis. The FDA initially approved Minivelle in October 2012 to treat moderate to severe vasomotor symptoms (VMS) due to Menopause. With this new approval, women who are using Minivelle to treat their VMS symptoms have the benefit of also helping to prevent Osteoporosis.

Minivelle is bioequivalent to Vivelle (estradiol transdermal system), which demonstrated safety and efficacy for the treatment of moderate to severe vasomotor symptoms due to menopause, commonly known as hot flashes. Efficacy and safety of Vivelle in the prevention of postmenopausal osteoporosis have been demonstrated in a 2-year double-blind, randomized, placebo-controlled, parallel group study. No clinical trials were conducted with Minivelle. The most commonly reported adverse events for Vivelle (at least5 percent) were headache, breast tenderness, back and limb pain, common cold, upset stomach, nausea, inflammation of the sinuses, and irregular vaginal bleeding or spotting. Minivelle is now approved with five dosing options � 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, and 0.1 mg/day, with the newly approved, lower dose of 0.025 mg/day indicated for the prevention of postmenopausal osteoporosis only.