PHILADELPHIA, July 20, 2016 /PRNewswire/ -- 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 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."
About Sparsha Pharma USA, Inc.: Sparsha Pharma USA, founded in 2012, is a pharmaceutical company which 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.
About Lannett Company, Inc.: 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.
This news release contains certain statements of a forward-looking nature relating to future events or future business performance. Any such statement, including, but not limited to, receiving FDA approval and successfully commercializing for Fentanyl Transdermal System, 12 mcg/hour, 25 mcg/hour, 50 mcg/hour, 75 mcg/hour and 100 mcg/hour, whether expressed or implied, is subject to market and other conditions, and subject to risks and uncertainties which can cause actual results to differ materially from those currently anticipated due to a number of factors which include, but are not limited to, the risk factors discussed in the Company's Form 10-K and other documents filed with the SEC from time to time, including the prospectus supplement related to the proposed offering to be filed with the SEC. These forward-looking statements represent the Company's judgment as of the date of this news release. The Company disclaims any intent or obligation to update these forward-looking statements.