The drug, Epidiolex, is intended to help treat seizures stemming from two rare but severe forms of epilepsy that first take hold during childhood.
The drug is produced by GW Pharmaceuticals, a British biotech company that is perhaps best known for the cannabis-based multiple sclerosis drug Sativex. That drug has been approved for use in as many as 30 countries outside of the United States.
The first-of-its-kind approval in the US could lead to more research and development of marijuana-based drugs going forward.
“This approval serves as a reminder that advancing sound development programmes that properly evaluate active ingredients contained in marijuana can lead to important medical therapies,” Scott Gottlieb, the commissioner of the FDA, said in a statement.
While medical marijuana has been legalised for medical purposes in nearly half of the states in the US — and a handful of states have legalised recreational use — the drug is still a Schedule 1 drug under federal law.
That means that the drug is considered by the US government to be of no medical value, and comes with a high likelihood of abuse.
The federal government has taken varying tactics towards enforcement of the drug, however.
During the presidency of Barack Obama, for instance, marijuana enforcement was not seen as a priority.
During the presidency of Donald Trump, however, Attorney General Jeff Sessions has indicated that his Justice Department will crack down on the drug across the country.
But, Mr Sessions has encountered difficulty in that effort, and has filed few if any lawsuits against companies selling marijuana in states where the drug is legally available.
Join our commenting forum
Join thought-provoking conversations, follow other Independent readers and see their replies