This would be the first new therapy in three decades.
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Depression affects millions of Americans and for many traditional anti-depressants don't work.
So this could potentially help a lot of people. However, the drug also comes with potential risks.
Years ago it was known as a party drug Special K, so in the wrong hands it could be abused.
However, some doctors are already offering a similar therapy - ketamine infusions - for patients willing to pay out of pocket.
I spoke with one young man who says it helped him.
"It was a really scary time for myself, for my family," says a 25-year-old student who asks we just call him Matt.
Last October, he fell into a very deep and dark depression.
"It's a feeling of hopelessness, of despair, of really being worried that nothing is ever going to turn out right for you," he recalls vividly.
Matt has bipolar disorder. Medication which helped him in the past stopped working.
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He even contemplated suicide.
While searching an online, he learned about ketamine, which led him to Actify Neurotherapies.
Actify founder psychiatrist Dr. Steve Levine started offering ketamine infusions to treat depression in 2011, seeing remarkable results.
"People who had been hospitalized over and over, were getting significantly better within a much shorter frame of time than we'd seen with traditional antidepressants," says Dr. Levine.
His success with ketamine in private practice led to the establishment of Actify, which has 9 clinics coast to coast.
Other therapies work by boosting serotonin. Ketamine works on another neurotransmitter, glutamate, repairing damaged pathways.
"As the month of December went on and I received 6 infusions with Actify, it just kept getting better at that point," says Matt.
Ketamine is FDA-approved in higher doses as an anesthetic during surgery.
Infusions for depression are what's called "off-label use." giving an approved drug for a different reason.
By March 4th, the FDA is expected to approve a similar treatment, esketamine, given via nasal spray. Janssen Pharmaceuticals, a division of Johnson and Johnson, says it will be sold under the brand name Spravato.
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However, there are concerns. Ketamine was once a club drug known as special K., popular for sparking out-of-body type experiences.
During an infusion, patients can feel similar, but milder effects.
"You're actually having beautiful, vivid dreams that are kind of playing out while you are completely aware you are awake," says Matt.
Dr. Levine says the risk for abuse is not being taken lightly.
"That makes it tremendously important that we select the right patients, that we adminster this in a carefully supervised medical environment," he says, drawing similarities to the infusions Matt receives at Actify.
Matt is still working on his mental health but feels fortunate to have found ketamine.
"I would say it's made a huge difference, absolutely," he notes.
If the nasal spray version is approved, insurance companies could start covering some of the cost, which would open the door to treat more people.
It will only be recommended for people who have tried at least two other treatments for depression.
And it will have to be given at a doctor's office. Patients could not give it to themselves.