Tagged Articles

Addyi 6 articles

Feds find female libido drug hidden in dietary supplements

Dietary supplements promoting sexual enhancement most often target men. In numerous cases, they are found to contain hidden drug ingredients including erectile dysfunction drugs like Viagra and Cialis. But a recent recall of dietary supplements issued by Organic Herbal Supply for supplements designed to boost female libido were found to contain undeclared flibanserin, a prescription medication sold under the brand name Addyi that was approved in late 2015 for the treatment of hypoactive sexual desire disorder in women. Food and Drug Administration (FDA) laboratory analysis on dietary supplements promoted for sexual enhancement has routinely turned up the presence of prescription-only ... Read More

Investors of ‘female Viagra’ pill sue manufacturer over botched marketing

It was a red-letter day in October 2015 when the Food and Drug Administration (FDA) approved the first female sexual enhancement medication for marketing in the U.S. The so-called female Viagra, sold under the brand name Addyi, had been rejected twice in the five years prior over doubts about its effectiveness and concerns of potential side effects. When it finally hit the market, expectations were high. A year later, Valeant Pharmaceuticals International Inc., which acquired the female libido pill from Sprout Pharmaceuticals Inc. in a $1 billion buyout last year, was slapped with a lawsuit by former Sprout investors. The lawsuit ... Read More

What’s the difference between ‘female Viagra’ Addyi and Viagra?

Addyi, the first “female Viagra” to be approved by the Food and Drug Administration (FDA), hit the market this week. But the drug has very little in common with its male counterpart. Viagra contains the drug ingredient sildenafil, which works by increasing blood flow to the penis in order to get and keep an erection. Addyi, on the other hand, works through the central nervous system. Addyi contains the drug flibanserin, which works by correcting an imbalance of dopamine and norepinephrine (both responsible for sexual arousal), while decreasing serotonin (which can inhibit sexual desire). They also carry very different side ... Read More

Valeant, Sprout announce partnership days after approval of so-called female Viagra

Two days after Sprout Pharmaceuticals Inc. made history by becoming the first drug company to gain approval for a so-called female Viagra pill, Valeant Pharmaceuticals International Inc. announced that it would be shelling out $1 billion in cash to buy Sprout. Sprout’s drug flibanserin, which will be sold under the brand name Addyi, is designed to treat low sexual desire in premenopausal women. The drug was approved amid controversy that included skepticism from researchers that the drug actually worked, and women’s advocacy groups that argued drug regulators were more reluctant to approve a sexual enhancement drug for women despite there being several ... Read More

FDA advisors recommend approving first-ever ‘female Viagra’

A “female Viagra” pill has gotten a nod by Food and Drug Administrator (FDA) advisors, paving the way for the first approved treatment for lack of sexual desire in women. The FDA will make the final decision whether to approve the drug for marketing. The agency is not required to follow the recommendations of its advisors, but it usually does. Filbanserin, which would be marketed as Addyi if approved, has been rejected two previous times by FDA panels based on efficacy doubts and side effects concerns. Analysts were quick to raise doubts whether the additional data provided by drug maker ... Read More

FDA advisors raise concerns over ‘female Viagra’ during third review

The Food and Drug Administration (FDA), for the third time, is raising concerns about safety risks with the so-called female Viagra drug currently under review. The agency says the drug can cause women to faint and accidentally injure themselves, especially if the medication is taken with alcohol. The concerns were published on the FDA’s website two days before an FDA advisory panel will decide whether to recommend approval of the drug or, for the third time, reject it based on concerns. The FDA is not required to follow the recommendations of its advisory panels, but it usually does. The drug ... Read More