Lannett: FDA Approves Oxycodone And Acetaminophen Tablets

(RTTNews) - Generic pharmaceutical company Lannett Co., Inc. (LCI) announced Wednesday that it received approval from the U.S. Food and Drug Administration of its Abbreviated New Drug Application or ANDA for Oxycodone and Acetaminophen Tablets, USP, 5 mg/325 mg and 10 mg/325 mg.

They are the therapeutic equivalent to the reference listed drug, Percocet Tablets, 5 mg/325 mg and 10 mg/325 mg, of Vintage Pharmaceuticals, LLC.

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 were approximately $571 million, according to IMS.

Arthur Bedrosian, chief executive officer of Lannett, said, "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.... We expect to commence marketing the drug along with other approved products in the next several months."