FDA approves Lannett’s ANDA for Butalbital, Acetaminophen and Caffeine Tablets

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.    

"Sales of Butalbital, Acetaminophen and Caffeine Tablets have been climbing five percent annually over the past three years," said Arthur P. Bedrosian, president and chief executive officer of Lannett. "This approval continues the positive momentum we have generated over the last several quarters. We have a number of product applications pending at the FDA, including several late-stage, large market opportunity drugs. Our active product development program is focused on expanding our pain management franchise. We thank our local FDA representatives, as well as the reviewers at the Office of Generic Drugs, who were helpful in getting our product applications approved."