Breckenridge announced that the Food and Drug Administration (FDA) has approved the Abbreviated New Drug Application (ANDA) for Gabapentin Oral Solution 250mg/5mL, the generic version of Pfizer’s Neurontin.
Gabapentin Oral Solution is indicated as adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in patients aged ≥3 years with epilepsy. The mechanism by which gabapentin exerts its anticonvulsant action is unknown, but in animal test systems designed to detect anticonvulsant activity, gabapentin prevents seizures as do other marketed anticonvulsants.
Gabapentin is structurally related to the neurotransmitter GABA (gamma-aminobutyric acid) but it does not modify GABA-A or GABA-B radioligand binding, it is not converted metabolically into GABA or a GABA agonist, and it is not an inhibitor of GABA uptake or degradation.
Breckenridge plans to ship Gabapentin Oral Solution 250mg/5mL shortly.
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