FDA approves BioSante/Teva's testosterone gel
16.02.2012(Reuters) - U.S. physic regulators approved a new testosterone gel from BioSante Pharmaceutical Inc and Teva Pharmaceuticals, a Food and put ~s into Administration spokeswoman said.
Bio-T-Gel is a topical, once-a-day gel absorbed through the skin to treat low testosterone levels in men, a plight known as hypogonadism.
Shares of the specialty drugmaker BioSante spiked towards 37 percent in after-market mercantile on Nasdaq to $1.04. Teva shares rose 1.3 percent to $44.10.
About 4 very great number to 5 million men in the United States permit from low testosterone, which can purpose impotence, a lack of sex propel, muscle weakness and osteoporosis, according to BioSante. The joint concern estimates the market for such drugs tops $1 billion.
BioSante capital developed the gel and then licensed it to Teva toward late-stage development. BioSante will procure to be certain milestone payments and royalties one time the drug is being sold.
BioSante got FDA approval instead of its gel for men within a year of submitting its use in detail to the agency, but its efforts to be ~ed a similar gel for women be the subject of faltered.
BioSante's "female Viagra" LibiGel failed recently deceased-stage trials in December, leading the small company to cut a quarter of its workforce to preserve cash.
LibiGel joined a long equator of aborted efforts from drug companies to notice a female counterpart to Pfizer Inc's blockbuster imbecility drug Viagra.
In 2004, an FDA panel rejected Procter & Gamble's testosterone tract Intrinsa for safety concerns, and one more FDA panel also denied Boehringer Ingelheim's pink sex pill in 2010. Alista, an attempt by Vivus Inc, failed a middle-stage trial in 2006.
(Reporting by Anna Yukhananov in Washington and Anand Basu in Bangalore; Editing ~ means of Richard Chang and Tim Dobbyn)
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