This article was originally published in Pharmaceutical Approvals Monthly
Estradiol transdermal patch approved August 16 in a 0.025 mg dosage and for new use in the prevention of postmenopausal osteoporosis. The patch was previously indicated for treatment of moderate-to-severe vasomotor symptoms associated with menopause, treatment of vulvar and vaginal atrophy and treatment of hypoestrogenism. Novogyne, a joint venture between Novartis and Noven, plans to submit an sNDA by year's end to extend the osteoporosis indication to its estrogen/progestin patch Vivelle Dot
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