Morphine Sulfate Oral Solution Approved by FDA

Earlier today, Covidien announced that Mallinckrodt business has received an FDA approval for Morphine sulfate oral solution, a drug used to alleviate moderate to severe acute and chronic pain in opioid-tolerant patients. The generic solution will be marketed in 100 milligrams per 5 mL (20 milligrams per 1 mL).

Chief Financial Officer and Interim President, Pharmaceuticals, Covidien, Matthew Harbaugh, said: “FDA approval of this drug represents a key component in palliative care treatment. It is important that we are able to respond to the concerns of the hospice and palliative care community.” Although Morphine sulfate oral solution has been used in pain management for years together, it was only in 2005 that Mallinckrodt began marketing the 20 milligram per 1 mL strength. However, this form and concentration of morphine had never received FDA approval before 2010.

The FDA announced in April 2009 that manufacturers could market morphine sulfate oral solution only until product approval was received, or an equivalent, permitted therapy was presented. Consequently, when an NDA by another manufacturer was approved in Jan 2010, Mallinckrodt withdrew its product from the market and initiated the existing approval process to sustain sufficient supply of this medication.