Lannett Company, Inc. announced that it recently received approval from the US Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Paroxetine extended release tablets USP, 12.5 mg, 25 mg and 37.5 mg, 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.

According to IMS, total US sales in 2015 of Paroxetine extended release-tablets USP, 12.5 mg, 25 mg and 37.5 mg, at Average Wholesale Price (AWP) were approximately $122 million. The company said it has begun shipping product to customers.

"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," said Arthur Bedrosian, chief executive officer of Lannett. "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.

"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."