Noven receives FDA new indication approval for Minivelle
Noven Pharmaceuticals has announced that the FDA has approved a new indication with a new dose of Minivelle (estradiol transdermal system) 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, commonly known as hot flashes. With this new approval, women who are using Minivelle to treat their VMS symptoms have the benefit of also helping to prevent osteoporosis.
The new 0.025mg/day patch is 33% smaller than Minivelle 0.0375mg/day that is already only about the size of a dime, the planet's smallest estrogen therapy patch ever. Minivelle now is approved with five dosing options -0.025mg/day, 0.0375mg/day, 0.05mg/day, 0.075mg/day, and 0.1mg/day, with the newly approved, lower dose of 0.025mg/day indicated for the prevention of postmenopausal osteoporosis only. If a patient uses Minivelle only to prevent osteoporosis from menopause, they should talk with their healthcare provider about whether a different treatment or medicine without estrogens might be better for them.
The new lower dose of 0.025mg/day is expected to be available in pharmacies in January 2015. Noven offers a savings program to help reduce the Minivelle co-pay for eligible patients. Eligible patients pay no more than $15 each month for up to 12 uses on their Minivelle prescriptions.