It will be sold as Spravato. Specifically, for patients who have tried at least two other medications without success, it should be taken with an oral antidepressant.
Spravato is a nasal spray administered by an authorized health care professional at a medical office or medical clinic. It can also be self-managed, but only under the supervision of a care provider and cannot be taken home.
"Because of [safety] concerns, the drug will only be available through a limited distribution system, and it must be administered at a certified medical office where healthcare professionals can monitor the patient," Farchione said.
Depending on the severity of the patient's depression, it is given either once a week or once every two weeks.
The drug works fast, so it starts to work faster than other antidepressants, according to Janssen. It works by restoring brain cells in patients with treatment-resistant depression.
Currently available treatments for severe depression are ineffective in 30% to 40% of patients. According to the FDA, another approved drug for treatment-resistant depression, Symbyax, was approved in 2009.
Side effects of Spravato include dizziness, nausea, dizziness, anxiety, lethargy, increased blood pressure, vomiting, feeling full, decreased sensitivity, sedation and dissociation, a sense of being temporarily "disconnected" from your body and your mind.
The dose tag will contain a "book warning" to alert patients to the risk of "sedation and difficulty with attention, assessment and thought (dissociation), abuse and abuse, and suicidal thoughts and behaviors following drug administration," the agency said in its announcement .
Due to these risks, patients must be monitored for at least two hours after receiving the drug.
In clinical trials, six patients who drew the drug were three suicides, but FDA backgrounds assessed by the Advisory Committee as recommended approval last year said: "It is difficult to regard these deaths as drugs in genealogy. "
Due to its close relationship with ketamine, experts have raised concerns about their potential for abuse and abuse, but clinical studies found that these risks were unfounded.
There have also been concerns about the lack of long-term data on possible health effects, especially cognitive.
The drug was designated as a breakthrough therapy in 2013, a state intended to "speed up the development and investigation of drugs for serious or life-threatening conditions," the FDA said at that time.
Greg Panico, a spokesman for Janssen, a division of Johnson & Johnson, did not say when Spravato will be available. He wrote in an email: "We work fast to educate and certify treatment centers on SPRAVATO ™ unique management requirements to ensure that patients can access this important medicine."
For the cost it will be "generally comparable to other specialties mental health drugs," Panico said: about $ 590 to $ 885 per treatment session, based on dosage and not accounting for mandatory discounts or negotiated discounts.
CNN's Michael Nedelman and Ben Tinker contributed to this report.