Lannett Company 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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