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Acella receives approval for generic gabapentin oral solution

Acella Pharmaceuticals, a specialty pharmaceutical company, has received approval of an Abbreviated New Drug Application (ANDA) for Gabapentin Oral Solution, 250 mg/5ml.

Acella Pharmaceuticals, a specialty pharmaceutical company, has received approval of an Abbreviated New Drug Application (ANDA) for Gabapentin Oral Solution, 250 mg/5ml.

The US Food and Drug Administration (FDA) found that Acella’s ANDA was bioequivalent or therapeutically equivalent to Neurontin Oral Solution, 250 mg/5ml, the reference listed drug.

Acella Pharmaceuticals vice president, head of Research and Development Allen Fields said, "Acella looks forward to adding Gabapentin Oral Solution to our existing line of products, as we continue our product development strategy of gaining approval from the FDA and global regulatory agencies for the ANDAs and NDAs in our pipeline."

Acella Pharmaceuticals CEO Mark Pugh said the approval and launch of the Gabapentin Oral Solution ANDA represents a significant milestone for the company and its research and development team.

"We look forward to continuing our commitment to developing and commercializing affordable products for our patients," Pugh said.