Lannett Announces Receipt of FDA Acceptable Filing Letter for Fentanyl Patch ANDA

PRNewswire: July 20, 2016 – PHILADELPHIA, PA, U.S.A. – Lannett Company, Inc. (NYSE: LCI) today 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, 25, 50, 75, 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.”

Sparsha Pharma USA, founded in 2012, is a pharmaceutical company that specializes in research, development, and manufacture of transdermal therapeutic systems. Sparsha Pharma USA is committed to advancing patient care throughout the world by providing high quality and affordable transdermal drug delivery product lines.

Lannett Company, founded in 1942, develops, manufactures, packages, markets, and distributes generic pharmaceutical products for a wide range of medical indications. For more information, visit the company’s website at www.lannett.com.