, May 2, 2012
/PRNewswire/ -- Acella Pharmaceuticals, LLC, a specialty pharmaceutical company, announces the approval of an Abbreviated New Drug Application (ANDA) for Gabapentin Oral Solution, 250 mg/5 mL. The Food and Drug Administration (FDA) determined that Acella's ANDA is bioequivalent therefore, therapeutically equivalent to the reference listed drug, Neurontin®* Oral Solution, 250 mg/5 mL.
"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," said Allen Fields, Vice President, Head of Research and Development for Acella Pharmaceuticals.
"We are excited about the approval and launch of the Gabapentin Oral Solution ANDA, as it represents a significant milestone for Acella Pharmaceuticals and our research and development team," added Mark Pugh, CEO of Acella Pharmaceuticals. "We look forward to continuing our commitment to developing and commercializing affordable products for our patients."
About Acella Pharmaceuticals, LLC
Acella develops, markets, sells and distributes a broad portfolio of non-branded pharmaceutical and other products in the areas of Dermatology, Women's Health, Pediatrics and other applications. Acella specializes in identifying and bringing to market quality, affordable products to customers and patients. For additional information please contact Acella at 678-325-5189.
* Neurontin is a registered trademark of Parke Davis.
SOURCE Acella Pharmaceuticals, LLC