Lannett Gets FDA Acceptable Filing Letter For Fentanyl Patch ANDA

Lannett Company, Inc. LCI revealed that its tactical partner, Sparsha Pharma USA, Inc., has got an Acceptable for Filing letter from the FDA for its Abbreviated New Drug Application (ANDA) for Fentanyl Transdermal System. According to the company, this was for 12 mcg/hour, 25 mcg/hour, 50 mcg/hour, 75 mcg/hour and 100 mcg/hour, the generic equivalent of Ortho McNeil'schronic pain treatment Duragesic.

Lannett quoted IMS and said total sales of Fentanyl Transdermal System products at Average Wholesale Price (AWP) were over $650 million in the United States last year.

The company's CEO, Arthur Bedrosian, said, "Expanding our pain management franchise is a key component of our growth strategy. 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."

On Tuesday, the stock closed at $28.85.