Amneal Pharmaceuticals has received FDA approval for a generic version of Onfi (clobazam) tablets, 10 mg and 20 mg for oral use, CIV, and Onfi (clobazam) oral suspension, 2.5 mg/mL ,CIV.
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"Amneal is pleased to receive approval on our clobazam tablets and clobazam oral suspension ANDAs," said Andy Boyer, Executive Vice President of Commercial Operations for Amneal. "We have immediately initiated commercialization activities for these first-to-market generic products."
According to IQVIA, U.S market annual sales for the 12 months ended August 2018 for Clobazam Tablets is estimated to be approximately $594 million and for Clobazam oral suspension is estimated to be approximately $255 million.