The FDA approved it for use in patients aged two and older who suffer from rare and severe forms of epilepsies known as Lennox-Gastaut syndrome and Dravet syndrome, which can develop early in childhood.
For the first time, the FDA is clearing a medication that contains a purified substance derived from marijuana. It is a chemical component of the Cannabis sativa plant and does not cause the intoxication or euphoria that comes from tetrahydrocannabinol (THC).
"This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies".
The FDA said the action isn't an approval of overall marijuana use, even if it's meant to treat other illnesses, but pharmacists said the FDA's decision could lead to more marijuana-derived drugs.
Both Lennox-Gastaut syndrome and Dravet syndrome arise in childhood, often leading to development problems.
"Today's approval demonstrates our commitment to the scientific process and working with product developers to bring marijuana-based products to market", he said. The drug, created by UK-based company GW Phramaceuticals, is also the first of its kind in anti-epilepsy medications.
GW Pharma's American depositary receipts fell less than 1 per cent to US$149.85 (RM599.43) at 1.03pm in NY.
The FDA also stated that if illegal CBD products make serious, unproven medical claims, then it will take action. Although medicinal use of cannabis is not legal in all U.S. states, the market for CBD is now estimated to be worth $200m, having doubled in size over the last two years as more investors look to cash in on the buzz around CBD.
The drug was studied in three randomized, double-blind, placebo-controlled clinical trials that involved 516 patients with either Lennox-Gastaut syndrome or Dravet syndrome, the FDA says.
A reclassification is expected within 90 days, according GW Pharmaceuticals.
Many parents already are giving children unregulated CBD formulations that are available in medical marijuana dispensaries in the many states where such operations are legal. "It's being delivered to patients in a reliable dosage form and through a reproducible route of delivery". This is the approval of one specific CBD medication for a specific use. But marijuana products in general are subject to Schedule I restrictions by the Drug Enforcement Administration (DEA) because of the potential for abuse.