Covidien today announced that the 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,” 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.