Mallinckrodt Announces Approval of New Gablofen® Prefilled Syringe

  Mallinckrodt Announces Approval of New Gablofen® Prefilled Syringe

   Gablofen^® (baclofen injection) in prefilled syringes helps simplify ITB
                                   refills

Business Wire

HAZELWOOD, Mo. -- January 21, 2013

Mallinckrodt, the Pharmaceuticals business of Covidien (NYSE: COV), today
announced the U.S. Food and Drug Administration (FDA) approval of Gablofen^®
(baclofen injection) in prefilled syringes. The Gablofen prefilled syringe was
created to reduce preparation steps, helping to simplify the pump refill
process for patients receiving ITB Therapy^SM (Intrathecal Baclofen Therapy)
to treat severe spasticity of cerebral and spinal origin.

“The launch of Gablofen prefilled syringe enhances our product portfolio and
provides a known treatment in a convenient delivery technology,” said Mark
Trudeau, President, Mallinckrodt. “The prefilled syringe has the opportunity
to replace the traditional glass ampules and simplify the pump refill process
for healthcare providers treating appropriate patients with severe
spasticity.”

A Refill Convenience Kit has been re-designed to include what is needed for
pump refills using Gablofen prefilled syringes. It includes snug compartments
to help ensure that each component stays in place.

Gablofen was developed by CNS Therapeutics, which was recently acquired by
Mallinckrodt. Gablofen prefilled syringes will be available in February 2013.
Gablofen is currently available in ready-to-use vials in the following
concentrations: 50 mcg/mL (screening dose), 500 mcg/mL, new 1,000 mcg/mL and
2,000 mcg/mL. Gablofen 1,000 mcg/mL, introduced in 2012, was the first new
refill concentration added in 20 years.

PLEASE SEE IMPORTANT RISK INFORMATION, INCLUDING BOXED WARNING BELOW.

SEE LINK TO FULL PRESCRIBING INFORMATION FOR ADDITIONAL IMPORTANT RISK
INFORMATION.

INDICATIONS AND USAGE

  * Gablofen (baclofen injection) is a gamma-aminobutyric acid (GABA) ergic
    agonist indicated for use in the management of severe spasticity of
    cerebral or spinal origin in adult and pediatric patients age 4 years and
    above.
  * Gablofen should be reserved for patients unresponsive to oral baclofen
    therapy, or those who experience intolerable central nervous system side
    effects at effective doses.
  * Patients should first respond to a screening dose of intrathecal baclofen
    prior to consideration for long term infusion via an implantable pump.
  * Spasticity due to traumatic brain injury: wait at least one year after
    injury before considering Gablofen therapy.

IMPORTANT RISK INFORMATION

                     WARNING: DO NOT DISCONTINUE ABRUPTLY

Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has
resulted in sequelae that include high fever, altered mental status,
exaggerated rebound spasticity, and muscle rigidity, that in rare cases has
advanced to rhabdomyolysis, multiple organ-system failure and death.
Prevention of abrupt discontinuation of intrathecal baclofen requires careful
attention to programming and monitoring of the infusion system, refill
scheduling and procedures, and pump alarms. Patients and caregivers should be
advised of the importance of keeping scheduled refill visits and should be
educated on the early symptoms of baclofen withdrawal. Special attention
should be given to patients at apparent risk (e.g. spinal cord injuries at T-6
or above communication difficulties, history of withdrawal symptoms from oral
or intrathecal baclofen). Consult the technical manual of the implantable
infusion system for additional post-implant clinician and patient information.

CONTRAINDICATIONS:

  * Hypersensitivity to baclofen.
  * Do not use Gablofen for intravenous, intramuscular, subcutaneous or
    epidural administration.

WARNINGS AND PRECAUTIONS

  * Use only with Medtronic SynchroMed^® II Programmable Pump (or other pumps
    labeled for intrathecal administration of Gablofen (baclofen injection))
  * Risk of life-threatening overdose during pump refills. Use extreme caution
    when filling the Medtronic SynchroMed^® II Programmable pump which is
    equipped with an injection port that allows direct access to the
    intrathecal catheter. Direct injection into the catheter through the
    catheter access port may cause a life-threatening overdose.
  * Resuscitative equipment and trained staff must be available during
    screening dose, dose titration, and refills due to the potential
    life-threatening CNS depression, cardiovascular collapse, and/or
    respiratory failure.
  * Overdose may cause drowsiness, lightheadedness, dizziness, somnolence,
    respiratory depression, seizures, rostral progression of hypotonia and
    loss of consciousness progressing to coma.
  * Use with caution in patients with psychotic disorders, schizophrenia or
    confusional state as it may exacerbate condition(s).
  * Fatalities have been reported with intrathecal baclofen use.
  * Caution should be used in patients with a history of autonomic
    dysreflexia.
  * Presence of infection may increase the risk of surgical complication and
    complicate dosing of Gablofen.
  * May cause drowsiness: use caution in operation of automobiles, dangerous
    machinery and activity that made hazardous by decreased alertness. Other
    CNS depressants and alcohol may add to this effect.
  * Potential development of intrathecal mass formation. Clinicians should
    monitor for signs and symptoms of new neurologic symptoms including the
    use of imagining diagnostic modalities.
  * Oral baclofen use has been associated with a dose related increase in
    incidence of ovarian cysts.
  * Pregnancy Category C. The effect of baclofen in labor and delivery is
    unknown
  * Balcofen is excreted into breast milk at oral therapeutic doses.
  * Pediatric use: Safety and effectiveness in pediatric patients below the
    age of 4 years have not been established.

SERIOUS ADVERSE EVENTS:

  * Sudden withdrawal of Gablofen can result in serious complications that
    include high fever, confusion, muscle stiffness, multiple organ-system
    failure, and death. Inform patients that early symptoms of Gablofen
    withdrawal may include increased spasticity, itching, and tingling of
    extremities. If Gablofen withdrawal or a pump malfunction is suspected,
    patients should be brought immediately to a hospital for assessment and
    treatment.
  * Gablofen overdose may occur suddenly or insidiously, and that symptoms may
    include confusion, drowsiness, lightheadedness, dizziness, slow or shallow
    breathing, seizures, loss of muscle tone, loss of consciousness, and coma.
  * Other serious adverse events may include: potential development of
    intrathecal mass formation, drainage, infection, meningitis, unmanageable
    trunk control, CSF leakage, coma and death.

COMMON ADVERSE EVENTS:

  * The most common adverse reactions in patients with spasticity of spinal
    origin were hypotonia (25.3%) somnolence (20.9%), dizziness,
    nausea/vomiting, hypotension, headache, and convulsions.
  * The most common adverse reactions in patients with spasticity of cerebral
    origin were hypotonia (34.7%), somnolence (18.7%), headache (10.7%)
    agitation, constipation, leukocytosis, chills, and urinary retention.
  * Other common adverse events may include hypoventilation, hypertonia,
    paresthesia, increased salivation, back pain, pruritus, diarrhea,
    peripheral edema, asthenia, pain, confusion, speech disorder, amblyopia,
    accidental injury and dry mouth.

For Full Prescribing Information about Gablofen, click here:
http://www.gablofen.com/downloads/Gablofen_Prescribing_Information.pdf

Lioresal is a registered trademark of Medtronic, Inc.
ITB Therapy^SM is a service mark of Medtronic Inc.

About Gablofen

Gablofen is indicated for use in the management of severe spasticity of
cerebral or spinal origin. Approved by the FDA in late 2010, Gablofen is a
branded, AP-rated alternative for Lioresal^® Intrathecal (baclofen injection)
and is listed in the FDA Orange Book: Approved Drug Products with Therapeutic
Equivalence Evaluations.

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 2012
revenue of $11.9 billion, Covidien has 43,000 employees worldwide in 70
countries, and its products are sold in over 140 countries. Please visit
www.covidien.com to learn more about our business.

Mallinckrodt, the Pharmaceuticals business of Covidien, is a vertically
integrated leader in providing products used in diagnostic procedures and in
the treatment of pain and related conditions. The company is the largest US
supplier, by prescription, of opioid pain medications and a leading
manufacturer of active pharmaceutical ingredients. It is also the largest US
supplier of the medical isotope technetium-99m and an industry leader in
radiopharmaceuticals and contrast media and delivery systems. Sales in 2012
were $2.0 billion. Please visit http://www.mallinckrodt.com to learn more
about our business.

Contact:

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