September 27, 2014
The FDA has approved a 33% smaller dose of the estradiol transdermal system for the prevention of postmenopausal osteoporosis, according to the manufacturer.
Minivelle (estradiol transdermal system, Noven Pharmaceuticals) is bioequivalent to Vivelle (estradiol transdermal system, Novartis AG) and was previously approved in 2012 for the treatment of vasomotor symptoms. That approval was for a dime-sized patch of 0.0375 mg/day. In this iteration, expected in 2015, Minivelle will be available in a 0.025 mg/day patch, which will be approximately 33% smaller and approved only for the prevention of postmenopausal osteoporosis, according to the release.