The FDA has approved a new indication with a new dose of Minivelle (estradiol transdermal system) for the prevention of postmenopausal osteoporosis, according to a press release issued by Noven Pharmaceuticals.
In October 2012, Minivelle was approved for treatment of moderate to severe vasomotor symptoms, such as hot flashes, during menopause.
The new dose is a 0.025 mg per day patch, which is 33% smaller than the Minivelle 0.0375 mg per day patch. Five doses are now approved for Minivelle, including 0.025 mg per day, 0.0375 mg per day, 0.05 mg per day, 0.075 mg per day and 0.1 mg/day. The newly approved 0.025-mg dose is indicated for prevention of postmenopausal osteoporosis only.
The release also stated that patients should consult with health care providers about whether a different treatment option without estrogens may be more appropriate if she is only using Minivelle for postmenopausal osteoporosis prevention.
Noven said they expect the new lower dose of Minivelle to be available in pharmacies in January 2015, according to the release.