Generic Clobazam Tablets Granted FDA Approval

OCTOBER 24, 2018
Kristen Coppock, MA, Editor
Breckenridge Pharmaceutical's Abbreviated New Drug Application for Clobazam Tablets, CIV, generic for Onfi® Tablets (Lundbeck), has been granted final approval by the FDA, according to the company. The new clobazam product is expected to be immediately lauched.1

Clobazam Tablets are a benzodiazepine indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients aged 2 years and older.1.2

Studies have shown that clobazam can decrease the frequency of seizures in people with refractory or uncontrolled seizures, but does not completely control them. The dose of clobazam used was important in those studies, according to the Epilepsy Foundation. People who were given the recommended higher dose had greater improvement in seizures than people who were given a lower dose of clobazam.2 

Breckenridge's generic product was developed by its vertically integrated manufacturing partner and will be available in 10mg and 20mg tablets.Onfi is available in the United States as 10 mg and 20 mg scored tablets, as well as 2.5 mg/mL oral suspension.2 

Adverse effects of clobazam are generally mild and usually disappear if the dose is reduced, according to the foundation. They may also go away over time as a person gets used to the medicine. Adverse effects most often reported include drowsiness, dizziness, poor coordination, drooling, and restlessness or aggressiveness.2

Although it is not fully known how Clobazam works in the brain, It is thought to affect neurotransmitters or substances in the brain that affect the way brain cells communicate, according to the foundation. The drug seems to involve or increase activity at GABA receptors on certain brain cells.2

Onfi® Tablets generated annual sales of $594 million dollars over 12 months ending August 31, 2018, according to industry sales data obtained by Breckenridge.1 

  1. Breckenridge Announces Final Approval of its ANDA for Clobazam Tablets (Generic for Onfi®) [news release]. Boca Raton, FL; October 23, 2018: Breckenridge Pharmaceutical, Inc. Accessed October 24, 2018.
  2. Epilepsy Foundation. Clobazam. Epilepsy Foundation website. Accessed October 24, 2018.