Lannett Gets FDA Approval To Launch Paroxetine Extended Release Tablets

Lannett Company, Inc.

revealed that it received FDA approval recently for its Abbreviated New Drug Application (ANDA) for Paroxetine Extended Release Tablets USP, 12.5 mg, 25 mg and 37.5 mg. The company also launched Paroxetine, which is the therapeutic equivalent to the reference listed drug, Paxil CR Extended-Release Tablets USP, 12.5 mg, 25 mg and 37.5 mg, of Apotex Technologies. Lannett quoted IMS to suggest that total sales of Paroxetine Extended Release-Tablets USP, 12.5 mg, 25 mg and 37.5 mg, at Average Wholesale Price (AWP) were approximately $122 million in the United States last year. It indicated that it commenced shipping product to customers. The company's CEO, Arthur Bedrosian, said, "Paroxetine Extended Release Tablets is the first major approval from our Kremers Urban (KU) subsidiary and comes just eight months after the acquisition was completed. I want to acknowledge our KU drug development team for their efforts in bringing this very difficult-to-develop product to patients suffering from depression. He added, "With only one other generic competitor currently available on the market, Paroxetine Extended Release Tablets represents a substantial opportunity for Lannett. The launch of Paroxetine, combined with our recently completed debt refinancing and six other recent product approvals, strengthens and reinforces our positive outlook for the coming year. Our fiscal 2017, which began on July 1, 2016, is currently exceeding our expectations." Shares of the company shed 0.41 percent on Friday.