Lannett Company, Inc. announced that its strategic partner, Sparsha Pharma USA, Inc., has received an Acceptable for Filing letter from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Fentanyl Transdermal System, 12 mcg/hour, 25 mcg/hour, 50 mcg/hour, 75 mcg/hour and 100 mcg/hour, the generic equivalent of Ortho McNeil's chronic pain treatment Duragesic®.
According to IMS, total U.S. sales in 2015 of Fentanyl Transdermal System products at Average Wholesale Price (AWP) were more than $650 million.
"Expanding our pain management franchise is a key component of our growth strategy," said Arthur Bedrosian, chief executive officer of Lannett. "Under the agreement, Sparsha Pharma USA will manufacture the product and Lannett will be responsible for distribution.
This alliance complements our Cody Labs active pharmaceutical ingredients (APIs) manufacturing operations and further supports and advances our plans for vertical integration."
