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BioSante Says FDA Accepts Teva New Drug Application For Bio-T-Gel

BioSante Pharmaceuticals, Inc. (BPAX) Wednesday said that the U.S. Food and Drug Administration or FDA accepted a New Drug Application or NDA for filing of Bio-T-Gel, following submission in January 2011 by a subsidiary of Teva Pharmaceutical Industries Ltd. (TEVA). The FDA assigned a PDUFA date of November 14, 2011. The PDUFA date is the target date for the FDA to complete its review of the NDA.

Bio-T-Gel is a testosterone gel for the treatment of male hypogonadism or low testosterone levels.

Bio-T-Gel was developed initially by BioSante, and then it was licensed to Teva for late stage clinical development. Teva is responsible for all Bio-T-Gel regulatory and marketing activities.

BioSante will receive certain milestone payments and royalties upon commercialization. The current U.S. market for male testosterone products is over $1.2 billion.

Stephen Simes, BioSante's president & CEO, commented, "We are extremely excited by Teva's NDA filing of Bio-T-Gel. We are confident that Teva has the expertise and resources to capture significant market share once Bio-T-Gel is launched. We look forward to receiving milestone payments and royalties on Bio-T-Gel after approval and launch."

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