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Clobazam Approval and Launch
[Oct 26, 2018]

Breckenridge Announces Final Approval of its ANDA for Clobazam Tablets (Generic for Onfi®)

 

Boca Raton, Florida, October 22 2018– Breckenridge Pharmaceutical, Inc. announced today that the U.S. Food and Drug Administration has granted final approval for its Abbreviated New Drug Application for Clobazam Tablets, CIV, generic for Onfi® Tablets by Lundbeck.  Breckenridge’s Clobazam product was developed by its vertically integrated manufacturing partner and will be available in 10mg and 20mg tablets. The company plans to launch immediately.

 

Clobazam Tablets are a benzodiazepine indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.   The brand Onfi® generated annual sales of $594 million dollars over the twelve months ending August 31, 2018, according to industry sales data.

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