BioSante Pharmaceuticals Files NDA For Elestrin In Israel

PharmaSwiss, Israeli licensee of BioSante Pharmaceuticals, has submitted a new drug application (NDA) for Elestrin in Israel.

The Elestrin filing is based on BioSante’ FDA approved NDA for the treatment of moderate-to-severe vasomotor symptoms (hot flashes), associated with menopause. According to the agreement, PharmaSwiss is responsible for regulatory and marketing activities in Israel.

Stephen Simes, President and CEO, BioSante Pharmaceuticals, said: “We believe PharmaSwiss is in an excellent position to capture an important share of the Israeli estrogen therapy market once Elestrin is approved. We look forward to working with PharmaSwiss on the successful marketing of Elestrin in Israel, and expanding the distribution of Elestrin beyond the US.”