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news.BioSante Pharmaceuticals said that Teva has received the US Food and Drug Administration's (FDA) acceptance for filing new drug application (NDA) of Bio-T-Gel.
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Bio-T-Gel, a treatment for low testosterone levels in males, was initially developed by BioSante Pharma, and then was licensed to Teva for further development.
As per the licensing agreement, Teva is responsible for all regulatory and marketing activities of the anti low testosterone drug.
Teva is also responsible to pay certain milestone payments and royalties to BioSante Pharma upon commercialization.
BioSante Pharma president and CEO Stephen Simes said they look forward to receiving milestone payments and royalties on Bio-T-Gel after approval and launch.