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Troubling questions loom over new FDA-approved drug for women
In June, the new FDA-approved drug Osphena will hit the shelves. Supposedly the newest answer for painful sex, it will be targeted by the drug maker Shionogi, Inc, the more than 64 million US women who have hit menopause. But Newsweek reports that numerous troubling questions loom over Osphena: is this a real disorder affecting substantial numbers of American women? How was Osphena approved? And is the drug simply a back-door replacement for the widely discredited "hormone replacement therapy"? Critics note that the two 12-week efficacy trials that satisfied the FDA were funded by the drug's developers.