Lannett Company, Inc announced plans to submit its New Drug Application (NDA) for its Morphine Sulfate products to the US Food and Drug Administration (FDA) at the end of the month. The company expects the US FDA to review its application on an expedited basis.
"Lannett has been manufacturing and distributing Morphine Sulfate products for some time," said Arthur Bedrosian, president and chief executive officer of Lannett. "Our morphine-based products are manufactured under strict compliance with cGMP, and we intend to continue to market our morphine products during the US FDA's review of our application."
The company noted that an article appeared last week in US FDA Week erroneously reporting that Lannett "doesn't plan to seek approval for its [morphine solution] product." The publication subsequently corrected the story on its website and will issue a correction in its next print edition.
Lannett Company, founded in 1942, develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of indications.