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Lannett ships Paxil CR generic

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PHILADELPHIA — Lannett Co. has been cleared by the Food and Drug Administration to market paroxetine extended-release tablets, an antidepressant, in strengths of 12.5 mg, 25 mg and 37.5 mg.

The company said its product, a generic version of Paxil CR extended-release tablets (12.5 mg, 25 mg and 37.5 mg) from Apotex Technologies, has begun shipping 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,” stated 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.

A a selective serotonin reuptake inhibitor (SSRI), paroxetine is indicated for the treatment of depression, obsessive-compulsive disorder, anxiety disorders, post-traumatic stress disorder and premenstrual dysphoric disorder.

U.S. sales of paroxetine extended-release tablets (12.5 mg, 25 mg and 37.5 mg) at average wholesale price (AWP) totaled about $122 million in 2015, according to IMS Health data reported by Lannett.

“With only one other generic competitor currently available on the market, paroxetine extended-release tablets represents a substantial opportunity for Lannett,” Bedrosian added. “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.”


ECRM_06-01-22


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