BRIDGEWATER, N.J. — Amneal Pharmaceuticals has launched what it said is the first generic Felbamate oral suspension in 600 mg/5 ml strength.
Amneal said Wednesday that the first-to-market product is an AB-rated, therapeutically equivalent alternative to Meda Pharmaceuticals’ Felbatol.
The Amneal generic comes in two sizes: 8 fl. oz./240 ml and 16 fl. oz./473 ml. The pink, bubble gum-flavored liquid doesn’t require refrigeration.
Annual U.S. sales of Felbatol, an anti-epileptic medication, were $17.6 million according to June 2011 IMS Health market data, reported Amneal, which received Food and Drug Administration approval for its product late last week.
"This approval further expands our liquids portfolio and complements our tablet-form of Felbamate, which launched in September," stated Chirag Patel, Amneal president. "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."
