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Bioequivalent estradiol patch approved for new indication dose

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.

Meeting News Coverage

FDA committees withhold approval of oral testosterone therapy

September 19, 2014
COLLEGE PARK, MD — On day 2 of a joint meeting on testosterone replacement therapies, the Bone, Reproductive and Urologic Drugs and Drug Safety and Risk Management…
FDA NewsPerspective

FDA committees near-unanimous on need to investigate testosterone therapies

September 18, 2014
COLLEGE PARK, MD — Two FDA advisory committees voted 20-1 in favor of revising the current indication for testosterone replacement therapies following several…
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Advisory Committee recommends approval of PTH therapy for hypoparathyroidism

September 15, 2014
After a debate-filled meeting today, the Endocrinologic and Metabolic Drugs Advisory Committee voted 8 to 5 in favor of approval for recombinant human parathyroid…
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