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.
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.