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news.Lannett Company has received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Codeine Sulfate Tablets USP, a schedule II controlled substance, 15mg, 30mg and 60mg, the therapeutic equivalent to the reference listed drug, Codeine Sulfate Tablets USP 15mg, 30mg and 60mg, of Roxane Laboratories.
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According to IMS, for the year ended April 2014 total sales of Codeine Sulfate Tablets USP 15mg, 30mg and 60mg at Average Wholesale Price (AWP) were about $4.3m.
The company expects to start shipping the product in the coming months.
Lannett president and chief executive officer Arthur Bedrosian said codeine Sulfate Tablets USP 15mg, 30mg and 60mg is the company’s second product approved by the FDA thus far in 2014.
"We currently have a number of product applications pending at the FDA and are hopeful to receive additional product approvals in the coming months," Bedrosian said.
"In addition, we continue to develop our pipeline, which includes 55 products in various stages of development."
Lannett develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of medical indications.