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Antares Pharma, Inc.

U.S. FDA issues new guidance on testosterone therapies for female sexual dysfunction

Published in Medical Device Law Weekly, December 4th, 2005

Antares Pharma, Inc., (AIS) announced that at the 3rd annual meeting of the International Society for the Study of Women's Sexual Health (ISSWSH), Daniel Shames, director of The Division of Reproductive and Urologic Products of the U.S. Food and Drug Administration (FDA), updated the agency's guidelines for the development of testosterone products for the treatment of female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD).

Shames reported the FDA is pursuing what he calls a policy of "feasibility" that is, a level of study that can be accomplished affordably and in a timely manner. Importantly Shames stated that he agrees that...

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