Hi-Tech Pharmacal Co., Inc.has received final approval for the Company’s Abbreviated New Drug Application, for gabapentin oral solution 250mg/5mL, which is the generic form of Pfizer’s Neurontin® oral solution, Neurontin® is indicated for postherpetic neuralgia and epilepsy.
As the Hi-Tech Pharmacal Co., Inc. was first filer ANDA filer with Paragraph IV certification, received 180 days of exclusivity and planning to launch generic gabapentin oral solution immediately. Neurontin® had sales of $15 million for the 12 months ended December 2010 according to IMS sales data.
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