The USA's BioSante Pharmaceuticals has licensed marketing rights for Elestrin (estradiol gel) in Israel to Swiss firm PharmaSwiss SA. The agent is indicated in the USA for the treatment of moderate-to-severe hot flashes associated with menopause. PharmaSwiss is responsible for regulatory and marketing activities in Israel. Financial terms of the agreement were not disclosed.
PharmaSwiss will submit BioSante's approved US New Drug Application to the authorities in Israeli, where marketing clearance in Israel is expected to take approximately one year.
Elestrin is a fast-drying gel formulation of estradiol, the same estrogen produced naturally in women. It is absorbed through the skin after topical application on the upper arm, and delivers estradiol to the bloodstream evenly over time in a non-irritating, painless manner. Elestrin is administered using a metered dose applicator that delivers 12.5mcg of estradiol, one of the two lowest doses approved by the FDA for the treatment of hot flashes. The gel dries in just one to two minutes.
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