Lancet Company Inc. recently announced that an Acceptable for Filing letter has been issued to its strategic partner Sparsha Pharma USA Inc. from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Fentanyl Transdermal System.
Fentanyl Transdermal System (12 mcg/hour, 25 mcg/hour, 50 mcg/hour, 75 mcg/hour and 100 mcg/hour) is used to treat chronic pain and is the generic version of Ortho McNeil’s Duragesic. More than $650 million of Fentanyl was sold in the United States last year. These sales are in accordance with Average Wholesale Price.
"Expanding our pain management franchise is a key component of our growth strategy," Lannett CEO Arthur Bedrosian said. "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 manufacturing operations and further supports and advances our plans for vertical integration."
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