Lannett Co. Inc. received approval from the U.S. FDA for the supplemental new drug application of its morphine sulfate oral solution CII.
The solution is an opioid agonist indicated for the management of acute and chronic pain in opioid-tolerant patients severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Lannett CEO Arthur Bedrosian stated that the company expects to launch the solution soon.
Total U.S. sales for the 12 months ended October for morphine sulfate oral solution, at average wholesale price, were about $22 million, according to IMS Health data.