Lannett announced that it received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Hydrocodone Bitartrate and Acetaminophen Tablets USP, 5 mg/300 mg, 7.5 mg/300 mg and 10 mg/300 mg, the therapeutic equivalent to the reference standard drug, Hydrocodone Bitartrate and Acetaminophen Tablets USP, 5 mg/300 mg, 7.5 mg/300 mg and 10 mg/300 mg, of Mikart, Inc. The product is also marketed under the brand names Vicodin, Vicodin ES and Vicodin HP. For the 12 months ended April 2017, total U.S. sales of Hydrocodone Bitartrate and Acetaminophen Tablets USP, 5 mg/300 mg, 7.5 mg/300 mg and 10 mg/300 mg, at Average Wholesale Price (AWP) were approximately $67.1million, according to IMS.
"The approval for Hydrocodone Bitartrate and Acetaminophen Tablets is an important and valuable combination drug product for our pain management franchise," said Arthur Bedrosian, chief executive officer of Lannett. "This approval, combined with two other recently approved ANDAs, will benefit our fiscal 2018 revenues. With 20 drug applications pending at the FDA we believe additional approvals are forthcoming."