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Bioequivalent estradiol patch approved for new indication dose
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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.
“We’re pleased that we now have an additional indication and the new dosage strength available for Minivelle to allow women and their doctors to individualize their treatment to best fit their needs,” Joel Lippman, MD, FACOG, Executive Vice President and Chief Medical Officer of Noven, said in the release.
The manufacturer referred to Vivelle data for efficacy and safety in the prevention of postmenopausal osteoporosis, but said no clinical trials were conducted on Minivelle.
For More Information:
Noven Receives FDA Approval of a New Indication with a New Dose for Minivelle