Amneal Pharmaceuticals, LLC is pleased to announce that its generic Felbamate tablets are now available in 400 mg and 600 mg strengths. Amneal's latest First-to-Market product is an AB-rated, therapeutically equivalent alternative to the antiepileptic drug Felbatol® (a registered trademark of Meda Pharmaceuticals Inc.). Annual U.S. sales of Felbatol® are $43.7 million according to January 2011 IMS Health market data. Amneal received U.S. FDA approval to manufacture Felbamate tablets on September 13, 2011.
“As Amneal rapidly matures, we will continue developing and commercializing unique generics such as Felbamate and numerous complex and controlled-release medications as well as adding new dosage forms”
The Amneal generic is available in 90-count bottles in 400 mg strength and 90- and 180-count sizes in 600 mg strength. Manufactured in Amneal's fully cGMP-compliant Brookhaven, NY plant, Felbamate tablets are currently shipping and available through wholesalers-distributors as well as directly to the trade.
"As Amneal rapidly matures, we will continue developing and commercializing unique generics such as Felbamate and numerous complex and controlled-release medications as well as adding new dosage forms," said Chirag Patel, Amneal's president. "To add these new products to our portfolio, we are aggressively expanding and deepening our R&D bench, bolstering our already-strong team with highly accomplished scientists who offer broad, diverse product development experience from both generic and brand manufacturers. Our significant investments in R&D will contribute greatly toward achieving Amneal's goal of becoming a Top 5 generics manufacturer in the United States."
Amneal Pharmaceuticals, LLC