BioSante Pharmaceuticals, Inc.
BioSante Pharmaceuticals Announces Elestrin™ NDA Submission in Israel
Published in Medical Letter on the CDC and FDA, July 12th, 2009
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) announced that an Elestrin (estradiol gel) new drug application (NDA) has been submitted in Israel by its Israeli licensee, PharmaSwiss SA. The Elestrin filing is based on BioSante's U.S. FDA approved NDA for the treatment of moderate-to-severe vasomotor symptoms (hot flashes) associated with menopause. PharmaSwiss is responsible for regulatory and marketing activities in Israel. Approval in Israel is expected to take approximately one year.
"This is a positive development by PharmaSwiss," said Stephen M. Simes, president & CEO of BioSante. "We believe PharmaSwiss is in an excellent position to capture an important share of...
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