Lannett Company, Inc. Receives FDA Approval for Butalbital, Acetaminophen and Caffeine Tablets USP, 50mg/325mg/40mg
Published: Sep 14, 2012
PHILADELPHIA--(BUSINESS WIRE)--Lannett Company, Inc. (NYSE MKT: 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.