FDA approves Lannett's codeine sulfate tablets

PHILADELPHIA — Lannett Co. received approval from the Food and Drug Administration for codeine sulfate tablets USP, a schedule II controlled substance, in 15 mg, 30 mg and 60 mg dosage strengths. It is the equivalent to codeine sulfate tablets USP 15 mg, 30 mg and 60 mg, from Roxane Labs.



“Codeine sulfate tablets USP 15 mg, 30 mg and 60 mg is our second product approved by the FDA thus far in 2014,” said Arthur P. Bedrosian, president and CEO of Lannett. “We currently have a number of product applications pending at the FDA and are hopeful to receive additional product approvals in the coming months. In addition, we continue to develop our pipeline, which includes 55 products in various stages of development.”



Codeine sulfate tablets USP had sales of approximately $4.3 million for the year ended April 2014, accoring to IMS Health.