AMITYVILLE, N.Y. — Generic drug maker Hi-Tech Pharmacal has received Food and Drug Administration approval for its version of a drug used to treat neurological disorders, the company said Tuesday.
Hi-Tech announced the approval of gabapentin oral solution in the 250 mg/5 mL strength, a generic version of Pfizer’s Neurontin oral solution.
The drug is used to treat postherpetic neuralgia and epilepsy. Neurontin had sales of $15 million in 2010, according to IMS Health.
As the first company to file for generic approval, Hi-Tech will get 180 days in which to compete directly with the branded version.