FDA OK's Lannett's codeine tabs


The U.S. regulator approves Lannett's (LCI +0.9%) ANDA for codeine sulfate tablets (15 mg, 30 mg, 60 mg). The reference drug for therapeutic equivalence was Roxanne Labs' codeine product. The company expects to commence shipping the product in the next several months.

According to IHM Health, total U.S. wholesale revenues for the 12-month period ending in April 2014 were ~$4.3M for the approved dosages.

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