Generics
Breckenridge wins final US FDA approval for Clobazam Tablets ANDA
24 October 2018 -

Pharmaceutical marketing company Breckenridge Pharmaceutical Inc revealed on Tuesday the receipt of the US Food and Drug Administration final approval for its Abbreviated New Drug Application for Clobazam Tablets, CIV in 10 mg and 20 mg tablets.

With immediate launch, the Clobazam Tablets are a benzodiazepine indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients two years of age or older, added the company.

The company's Abbreviated New Drug Application for Clobazam Tablets, CIV is the generic for Onfi Tablets by Lundbeck. The brand Onfi generated annual sales of USD594m over the 12 months ending 31 August 2018, according to industry sales data.

According to the company, the Clobazam product was developed by its vertically integrated manufacturing partner.

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