PHILADELPHIA — Lannett Co. has received approval from the Food and Drug Administration for oxycodone hydrochloride oral solution (100 mg per 5 ml).
The generic pharmaceuticals company said Wednesday that its product is the therapeutic equivalent to the reference listed drug, oxycodone hydrochloride oral solution (100 mg per 5 ml), of Lehigh Valley Technologies Inc.
An opioid pain medication, oxycodone hydrochloride oral solution is used in the treatment of moderate to severe pain.
At the average wholesale price (AWP), annual sales of oxycodone hydrochloride oral solution (100 mg per 5 ml) total approximately $43 million, according to IMS Health data cited by Lannett.
"Oxycodone hydrochloride oral solution USP (100 mg per 5 ml) is an important and long-awaited addition to our pain management franchise and represents our fourth product approved by the FDA thus far in 2014," stated Arthur Bedrosian, president and chief executive officer of Lannett. "We expect to launch the product shortly."
