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The approval of the controversial drug, flibanserin, which the FDA twice rejected before and now will be marketed as Addyi, comes with a series of conditions reflecting the agency’s concerns about serious side effects. These include a boxed warning that highlights the risks of low blood pressure and fainting in patients who drink alcohol while taking the drug, as well as a requirement that doctors complete a training course before being allowed to prescribe it. (Schulte and Dennis, 8/18)

The drug — Addyi from Sprout Pharmaceuticals — is actually the first drug approved to treat a flagging or absent libido for either sex. Viagra and other drugs available for men are approved to help achieve erections, or to treat certain deficiencies of the hormone testosterone, not to increase desire. (Pollack, 8/18)

The decision follows a public campaign challenging the agency to close a widening gap between the number of drugs available for men’s sexual health and those available to women. ... Clinical trials presented to the FDA showed that compared with pre-menopausal women who got a placebo, those who took flibanserin reported a modest but measurable rise in sexual desire and increased their number of “sexually satisfying encounters” by roughly one per month, from a median of two to three to between 2 1/2 and four. (Healy, 8/18)

The controversial decision was hailed by some doctors and advocates as a long-sought victory for women's health, but was condemned by others as irresponsible and dangerous. ... The medicine is to be taken daily to treat premenopausal women suffering from hypoactive sexual desire disorder, which is essentially a sudden, unexplained loss of any desire to have sex. (Stein, 8/18)

But the agency’s decision on Tuesday — which follows a well-orchestrated advocacy campaign financed by the drug’s maker, Sprout Pharmaceuticals — comes with a requirement that the company take steps to ensure doctors prescribe flibanserin carefully and make women aware of its health risks. (Karlin, 8/18)

“It’s not for everybody,” said Dr. Lisa Larkin, director of the women’s health center at the University of Cincinnati. “Not all women who have low desire have a biologic basis. We understand that very clearly. But there’s a subgroup of patients where biology really is the issue and it’s that group of patients who will be candidates for this medication.” Addyi can cause a severe drop in blood pressure and a loss of consciousness, risks that increase when taken with alcohol and other medications that impede the drug’s breakdown in the body. (Pugh, 8/18)

Federal health officials on Tuesday approved the first-ever prescription drug intended to treat women suffering from a lack of sexual desire, ending a vigorous debate over the drug's fate. ... Here's a look at the new drug from Sprout Pharmaceuticals. (8/18)

A small drugmaker from North Carolina may succeed next week where many of the world's largest pharmaceutical companies have failed: in winning approval for the first drug to boost women's sexual desire. The husband-and-wife team that founded Sprout Pharmaceuticals is not new to the pharmaceutical business or even to marketing drugs to people frustrated with their sex lives. The couple's previous company, Slate Pharmaceuticals, sold an implantable testosterone pellet to men with low levels of the hormone. But Slate's marketing push ran afoul of federal rules, making misleading, unsupported statements about the benefits of testosterone therapy while downplaying risks. In fact, when the Food and Drug Administration held a meeting examining the overprescribing of testosterone last year, it played Slate's commercial as an example of inappropriate marketing. That record worries Sprout's critics, who see a troubling pattern in the aggressive tactics it has used to urge the FDA to approve the women's desire drug, which was previously rejected twice because of lackluster effectiveness and side effects such as nausea, dizziness and fainting. (Perrone, 8/18)