The USFDA has approved Lannett Company abbreviated new drug application (ANDA) for Butalbital, Acetaminophen and Caffeine Tablets, USP, 50mg/325mg/40mg.
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The company anticipates initiation of product shipment shortly.
Lannett president and chief executive officer Arthur Bedrosian said that sales of Butalbital, Acetaminophen and Caffeine tablets have been climbing 5% annually over the past three years.
"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," Bedrosian added.
The total sales of Butalbital, Acetaminophen and Caffeine Tablets at Average Wholesale Price (AWP) were approximately $30m for the year ended July 2012, according to IMS.