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AMITYVILLE, N.Y. — Hi-Tech Pharmacal Co. has been cleared to market gabapentin oral solution, a treatment for epilepsy and postherpetic neuralgia.
The specialty pharmaceuticals company said Tuesday that the Food and Drug Administration granted final approval for its abbreviated new drug application (ANDA) for gabapentin oral solution 250mg/5mL, the generic version of Pfizer’s Neurontin oral solution.
Hi-Tech noted that its application included a Paragraph IV certification, and the FDA has granted the company 180 days of exclusivity for the generic medication, which it plans to launch immediately.
An anti-epileptic medication, gabapentin affects chemicals and nerves in the body that are involved in the cause of seizures and some kinds of pain. The drug also is indicated for the treatment of nerve pain caused by herpes virus or shingles (herpes zoster).
According to data from IMS Health, Pfizer’s Neurontin oral solution had sales of $15 million for the 12 months ended in December, Hi-Tech reported.
