Lannett Gets FDA Approval for Butalbital, Acetaminophen
Lannett Company (NYSE: LCI) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Butalbital, Acetaminophen and Caffeine Tablets, USP, 50mg/325mg/40mg. According to IMS, for the year ended July 2012 total sales of Butalbital, Acetaminophen and Caffeine Tablets at Average Wholesale Price (AWP) were approximately $30 million, of which about $15 million was for the brand version, Fioricet^®. The company expects to commence shipping the product next month.
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