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news.Hi-Tech Pharmacal, a New Jersey-based specialty pharmaceuticals company, has received final approval for its abbreviated new drug application (ANDA) for gabapentin oral solution 250mg/5mL from the US Food and Drug Administration (FDA).
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Gabapentin is the generic for Pfizer’s Neurontin oral solution, and is indicated for the treatment of postherpetic neuralgia and epilepsy.
Hi-Tech Pharmacal is planning to launch generic gabapentin oral solution immediately, now that the FDA has granted it 180 days of exclusivity.
Currently, Hi-Tech has 14 products awaiting approval at the FDA, which it expects will bring in brand and generic sales of approximately $1bn.
Hi-Tech also has 20 products, including sterile ophthalmic products, oral solutions and suspensions and nasal sprays, in active development which it hopes will bring in brand sales of over $3bn.