The FDA approved Addyi, to treat acquired, generalized hypoactive sexual desire disorder in premenopausal women, according to a press release on the agency's website.
Often referred to as 'female Viagra,' it is the first such treatment approved by the agency to treat the disorder.
The once-a-day, non-hormonal drug could be available by prescription by Oct. 17, according to manufacturer Sprout Pharmaceuticals.
As The Washington Post points out, however, the approval has not come without a bit of controversy.
Some of that worry is pointed out by the FDA themselves in the press release announcing the approval, specifically the drug's interaction with alcohol.
"Addyi is being approved with a risk evaluation and mitigation strategy (REMS), which includes elements to assure safe use (ETASU)," reads the statement. "The FDA is requiring this REMS because of the increased risk of severe hypotension and syncope due to the interaction between Addyi and alcohol."
It continued: "Addyi is also being approved with a Boxed Warning to highlight the risks of severe hypotension and syncope in patients who drink alcohol during treatment with Addyi, in those who also use moderate or strong CYP3A4 inhibitors, and in those who have liver impairment."
