FDA Approves Lannett's Oxycodone Hydrochloride Capsules 5 mg
Lannett Company today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Oxycodone Hydrochloride Capsules, 5 mg, the therapeutic equivalent to the reference listed drug, Oxycodone Hydrochloride Capsules, 5 mg, of Lehigh Valley Technologies, Inc. According to IMS, for the year ended June 2014 total sales of Oxycodone Hydrochloride Capsules, 5 mg, at Average Wholesale Price (AWP) were approximately $7.1 million. The company expects to commence shipping the product in the coming months.
“Oxycodone Hydrochloride Capsules, 5 mg, represents our third product approved by the FDA thus far in 2014, and, importantly, adds to our goal of vertical integration,” said Arthur P. Bedrosian, president and chief executive officer of Lannett. “We hope to receive additional product approvals in the near future while we continue to develop our robust pipeline.”