Lannett Company, Inc. announced that it has received approval from the US Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Neomycin sulfate tablets USP, 500 mg, the therapeutic equivalent to the reference listed drug, Neomycin sulfate tablets USP, 500 mg, of Teva Pharmaceuticals USA, Inc.
According to IMS, total US sales in 2015 of Neomycin sulfate tablets USP, 500 mg, at Average Wholesale Price (AWP) were approximately $3 million.
"The approval for Neomycin sulfate tablets expands our portfolio of anti-infective and antibiotic products and represents our fifth approval in 2016," said Arthur Bedrosian, chief executive officer of Lannett. "We expect to commence marketing the product in the next several months, adding to our positive momentum as we enter the coming fiscal year."
Lannett Company, founded in 1942, develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of medical indications.