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Lannett Announces Approval And Launch Of Paroxetine Extended Release Tablets USP, 12.5 Mg, 25 Mg, 37.5 Mg

PHILADELPHIA, July 11, 2016 /PRNewswire/ -- Lannett Company, Inc. (LCI) today announced that it recently received approval from the U.S. 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 U.S. 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...


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