Lannett Receives FDA Approval for Oxycodone, Acetaminophen Tablets

Lannett has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Oxycodone and Acetaminophen Tablets, USP, 5 mg/325 mg and 10 mg/325 mg, the therapeutic equivalent to the reference listed drug, Percocet Tablets, 5 mg/325 mg and 10 mg/325 mg, of Vintage Pharmaceuticals.  For the 12 months ended July 2017, total U.S. sales of Oxycodone and Acetaminophen Tablets, USP, 5 mg/325 mg and 10 mg/325 mg, at Average Wholesale Price (AWP) were approximately $571 million, according to IMS.

"To say that we are on a roll is putting it mildly," said Arthur Bedrosian, chief executive officer of Lannett.  "Oxycodone and Acetaminophen Tablets extends our pain management franchise and represents our ninth approval thus far in calendar 2017, which is quite an accomplishment for Lannett.  We are hopeful that we can exceed the 11 product approvals received last year; I commend our entire team for their diligence and ongoing efforts.  We expect to commence marketing the drug along with other approved products in the next several months.  Our planned product launches, combined with our on-going integration and cost reduction efforts, are just some of the factors that give us confidence Lannett's future is bright."