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News Release

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Covidien Receives FDA Approval for Morphine Sulfate Oral Solution

ST. LOUIS, Aug 01, 2011 (BUSINESS WIRE) -- 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," 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.

IMPORTANT RISKINFORMATION

Morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL)is an opioid analgesic indicated for the relief of moderate to severe acute and chronic pain in opioid-tolerant patients.

WARNING: RISK OF MEDICATION ERRORS

Morphine sulfate oral solution is available in the 100 mg per 5 mL

(20 mg/mL) concentration and is indicated for use in opioid-tolerant patients only.

Take care when prescribing and administering morphine sulfate oral solution to avoid dosing errors due to confusion between different concentrations and between mg and mL, which could result in accidental overdose and death. Take care to ensure the proper dose is communicated and dispensed.

Keep morphine sulfate oral solution out of the reach of children. In case of accidental ingestion, seek emergency medical help immediately.

Morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL) is contraindicated in:

  • Patients with known hypersensitivity to morphine, morphine salts, or any components of the product.
  • Patients with respiratory depression in the absence of resuscitative equipment.
  • Patients with acute or severe bronchial asthma or hypercarbia.
  • Any patient who has or is suspected of having paralytic ileus.

-Morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL) may cause fatal respiratory depression when administered to patients not previously exposed to opioids

-Patients considered to be opioid tolerant are those who are taking at least 60 mg oral morphine per day, or at least 30 mg of oral oxycodone per day, or at least 12 mg hydromorphone per day, or an equianalgesic dose of another opioid, for a week or longer

-For ORAL use only

-Always use the enclosed calibrated oral syringe when administering morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL) to ensure the dose is measured and administered accurately

-Respiratory depression is the primary risk of morphine sulfate. Respiratory depression occurs more frequently in elderly or debilitated patients and in those suffering from conditions accompanied by hypoxia, hypercapnia, or upper airway obstruction, in whom even moderate therapeutic doses may significantly decrease pulmonary ventilation

-Use with extreme caution in patients with chronic obstructive pulmonary disease or cor pulmonale and in patients having a substantially decreased respiratory reserve (e.g., severe kyphoscoliosis), hypoxia, hypercapnia, or preexisting respiratory depression. In such patients, even usual therapeutic doses of morphine sulfate may increase airway resistance and decrease respiratory drive to the point of apnea. Consider alternative non-opioid analgesics, and use morphine sulfate only under careful medical supervision at the lowest effective dose in such patients

-Morphine sulfate is an opioid agonist and a Schedule II controlled substance. Such drugs are sought by drug abusers and people with addiction disorders. Diversion of Schedule II products is a risk and an act subject to criminal penalty

-Morphine sulfate can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing morphine sulfate in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion

-Do not use with alcohol and use caution with other medications that cause CNS or respiratory depression

-In the presence of increased intracranial pressure, the possible respiratory depressant effects and its potential to elevate cerebrospinal fluid pressure may be markedly exaggerated.

-The effects on pupillary response and consciousness, which may obscure neurologic signs of further increases in intracranial pressure in patients with head injuries should be considered in such patients

-May obscure the diagnosis or clinical course in patients with acute abdominal condition

-Use with caution and in reduced dosages in patients with severe renal or hepatic impairment, Addison's disease, hypothyroidism, prostatic hypertrophy, or urethral stricture, and in elderly or debilitated patients

-Exercise caution in the administration of morphine sulfate to patients with CNS depression, toxic psychosis, acute alcoholism and delirium tremens.

-All opioids may aggravate convulsions in patients with convulsive disorders, and all opioids may induce or aggravate seizures in some clinical settings.

-Caution patients about the potential for impairment of mental and/or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery.

-Serious adverse reactions associated with morphine sulfate use include: respiratory depression, apnea, and to a lesser degree, circulatory depression, respiratory arrest, shock, cardiac arrest and death

-The most common adverse events are constipation, nausea, and somnolence. Other commonly observed adverse reactions include: lightheadedness, dizziness, sedation, vomiting, and sweating. The frequency of these events depends upon several factors including clinical setting, the patient's level of opioid tolerance, and host factors specific to the individual. Anticipate and manage these events as part of opioid analgesia therapy.

-Not intended for use in pregnancy or lactation. The safety and efficacy in patients less than 18 years has not been established

-Physical dependence and tolerance are not uncommon in opiod therapy. Do not abruptly discontinue as withdrawal syndrome will likely be initiated.

ABOUT COVIDIEN

Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in three segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2010 revenue of $10.4 billion, Covidien has approximately 41,000 employees worldwide in more than 65 countries, and its products are sold in over 140 countries. Please visit http://www.covidien.com to learn more about our business.

SOURCE: Covidien

Covidien
Lynn Phillips, 314-654-3263
Manager, Media Relations
lynn.phillips@covidien.com
or
Coleman Lannum, CFA, 508-452-4343
Vice President, Investor Relations
cole.lannum@covidien.com
or
Steve Littlejohn, 314-654-6595
Vice President, Communications
stephen.littlejohn@covidien.com
or
Todd Carpenter, 508-452-4363
Director, Investor Relations
todd.carpenter@covidien.com