BioSante Pharmaceuticals, Opposition. (NASDAQ: BPAX) at present proclaimed that a Different Panacea Reference (NDA) has bent authorized on filing near the U.S. Aliment and Medicine Direction (Authority) masses yielding in Jan 2011 near a help of Teva Pharmaceutic Industries Ltd. (NASDAQ: TEVA). The Office has allotted a PDUFA year of Nov 14, 2011. The PDUFA period is the goal stage on the Authority to whole its inspect of the NDA.
“We are to the nth degree perturbed through Teva’s NDA filing of Bio-T-Gel”
Bio-T-Gel is a testosterone colloid as a service to the communicating of eunuchoidism or stubby testosterone levels. Bio-T-Gel was mature initially via BioSante, so it was qualified to Teva representing delayed position clinical situation. Teva is responsible the entire Bio-T-Gel regulative and promotion activities. BioSante desire collect determined signpost payments and royalties upon exploitation. The simultaneous U.S. demand championing manly testosterone commodities is above $1.2 zillion.
“We are uncommonly stirred up through Teva’s NDA filing of Bio-T-Gel,” assumed Writer M. Simes, BioSante’s manager & CEO. “We are secure that Teva has the know-how and resources to arrest noteworthy store apportionment in days gone by Bio-T-Gel is launched. We examine impudent to receiving target payments and royalties on Bio-T-Gel later affirmation and inaugurate.”