Lannett to submit NDA (AMEX:LCI)

Products comprising of Morphine Sulfate have been developed by the Lannett Company, Inc. (AMEX:LCI). These products had been produced and later distributed by the company for several years. However, now, the company wants to bring those products into the markets of the United States of America. For this purpose, it needs the approval from the country’s regulator – namely, the Food and Drug Administration (FDA). On February 2, 2010, the company announced that it wants to submit the New Drug Application (NDA) for the morphine sulfate products to the FDA. This is the application that all pharmaceutical companies must submit to the FDA if they want to bring any new drug into the market. The company said it would submit the application “at the end of the month”. So, all its stakeholders are hoping that the NDA would be submitted by February 28, 2010, though the company has not confirmed the date again.

The company also hopes that the Food and Drug Administration would start and complete reviewing the application in a very short period of time so that the company gets to know about the decision as soon as possible.

Arthur Bedrosian, who is the Chief Executive Officer and also the President of Lannett Inc., seemed very confident about the morphine sulfate products. He said, “Our morphine-based products are manufactured under strict compliance with cGMP”. In addition, he announced that the company would not stop marketing these products while the NDA is being reviewed.

The company also dissolved confusion regarding a recent piece of news in FDA Week. The company clarified that the news was false and that the company has never thought about continuing to market its morphine sulfate products without getting the FDA’s approval. The company has also let the FDA know about the false news and the regulator has agreed to post the correct news in the subsequent edition of FDA Week.

Although Lannett Company Inc. has a few brand name drugs under its pipeline, it is most popular for selling generic drugs. Its offices are located in Philadelphia, Pennsylvania.