Lannett announced it has received FDA approval of its Abbreviated New Drug Application (ANDA) for Codeine Sulfate Tablets, the equivalent version of Roxane Laboratories’ Codeine Sulfate.

Codeine Sulfate is a Schedule II opioid indicated for the relief of mild to moderately severe pain where the use of an opioid analgesic is appropriate. Codeine is selective for the mu receptor, but with a much weaker affinity than morphine. The analgesic properties of codeine have been presumed to come from its conversion to morphine, although the exact mechanism of analgesic action remains unknown.

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Codeine Sulfate Tablets will be available in 15mg, 30mg, and 60mg strengths. Lannett plans to commence shipment in the coming months.

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