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Lannett Company Inc receives FDA approval for Codeine Sulfate Tablets USP, 15 mg, 30 mg and 60 mg


Monday, 16 Jun 2014 12:37pm EDT 

Lannett Company Inc:Receives approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA).Approval for Codeine Sulfate Tablets USP, schedule II controlled substance, 15 mg, 30 mg and 60 mg, the therapeutic equivalent to the reference listed drug, Codeine Sulfate Tablets USP 15 mg, 30 mg and 60 mg, of Roxane Laboratories, Inc.According to IMS, for year ended April 2014 total sales of Codeine Sulfate Tablets USP 15 mg, 30 mg and 60 mg at Average Wholesale Price (AWP) were about $4.3 mln.Company expects to commence shipping product in coming months. 

Company Quote

24.82
-1.91 -7.15%
5 Feb 2016