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Amneal gets FDA nod for generic Onfi

Amneal Pharmaceuticals has received the Food and Drug Association's nod for a generic version of Lundbeck’s Onfi (clobazam) tablets, 10 mg and 20 mg for oral use and Onfi (clobazam) oral suspension 2.5 mg/ml.

Onfi is a prescription medicine used along with other medicines to treat seizures associated with Lennox-Gastaut syndrome in people age 2 years old and older.

"Amneal is pleased to receive approval on our clobazam tablets and clobazam oral suspension ANDAs," Amneal executive vice president of commercial operations Andy Boyer said in a statement. "We have immediately initiated commercialization activities for these first-to-market generic products."

Clobazam tablets had a market value of approximately $594 million for the 12 months ended August 2018, and Clobazam oral suspension had a market value of approximately $255 million, according to IQVIA data.
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