Covidien (NYSE: COV), a leading global provider of healthcare products, today announced that the U.S. Food and Drug Administration (FDA) recently granted 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).
“FDA approval of this drug represents a key component in palliative care treatment”
"FDA approval of this drug represents a key component in palliative care treatment," said Matthew Harbaugh, Chief Financial Officer and Interim President, Pharmaceuticals, Covidien. "It is important that we are able to respond to the concerns of the hospice and palliative care community."
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.
In April, 2009, the FDA announced that manufacturers could keep morphine sulfate oral solution on the market, but only until the product was approved, or an equivalent, approved therapy was available. Accordingly, upon approval of a new drug application (NDA) by another manufacturer in January 2010, Mallinckrodt removed its product from the market. Mallinckrodt undertook the current approval process to ensure adequate supply of this medication to patients.
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