FDA Approves Morphine Sulfate Oral Solution

Covidien has received approval from the FDA for morphine sulfate oral solution used to relieve moderate to severe acute and chronic pain in opioid-tolerant patients.

Covidien, a global provider of healthcare products, announced Monday the FDA's recent approval to the company's Mallinckrodt business for morphine sulfate oral solution, used to relieve moderate to severe acute and chronic pain in opioid-tolerant patients.

The solution will be available as a generic in 100 milligrams per 5 mL (20 milligrams per 1 mL).

Morphine sulfate oral solution has been used to manage pain for many years, and Mallinckrodt began marketing the 20 milligram per 1 mL strength in 2005. Prior to 2010, however, this form and concentration of morphine had never been approved by the FDA.

"FDA approval of this drug represents a key component in palliative care treatment,”