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PHILADELPHIA — Lannett Co. has gained approval from the Food and Drug Administration for neomycin sulfate tablets 500 mg, an antibiotic.
Lannett said Monday that its product is a therapeutic equivalent to the reference listed drug, neomycin sulfate tablets (500 mg) from Teva Pharmaceuticals USA Inc.
“The approval for neomycin sulfate Tablets expands our portfolio of anti-infective and antibiotic products and represents our fifth approval in 2016,” Lannett chief executive officer Arthur Bedrosian stated. “We expect to commence marketing the product in the next several months, adding to our positive momentum as we enter the coming fiscal year.”
Neomycin is indicated for use to lower the risk of infection during intestinal surgery. The medication also is used to reduce the symptoms of hepatic coma.
U.S. sales of neomycin sulfate tablets (500 mg) in 2015, at average wholesale price, totaled approximately $3 million, according to IMS Health data reported by Lannett.
