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news.Amneal Pharmaceuticals has released the first generic Felbamate oral suspension in 600 mg/5 mL strength.
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The AB-rated product is a therapeutically equivalent alternative to the antiepileptic Felbatol (a registered trademark of Meda Pharmaceuticals).
The Amneal generic is available in two sizes, 8 fl oz/240 mL and 16 fl oz/473 mL.
The pink, bubble gum-flavored liquid does not require refrigeration and is manufactured in Amneal’s cGMP-compliant plant in New Jersey, the company said.
Amneal president Chirag Patel said the FDA nod would help in the expansion of their liquids portfolio.
"Additionally, by bringing another first-to-market generic to the public, we are reinforcing our commitment to provide pharmacy customers and the consumer with high-quality, affordable pharmaceuticals," Patel added.
The US FDA has approved Amneal’s ANDA for Felbamate oral suspension on 16 December 2011.