Hospira Obtains Six Months U.S. Pediatric Exclusivity for Precedex™
(dexmedetomidine HCl) Injection
LAKE FOREST, Ill., March 18, 2013
LAKE FOREST, Ill., March 18, 2013 /PRNewswire/ --Hospira, Inc.(NYSE: HSP),
the world's leading provider of injectable drugs and infusion technologies,
today announced that the U.S. Food and Drug Administration (FDA) has granted
pediatric exclusivity for Hospira's alpha-2 agonist Precedex^™
(dexmedetomidine HCl) injection. Based on this decision by the FDA, the period
during which a generic application may not be approved has been extended by a
period of six months after patent expiry.
The approval of pediatric exclusivity does not mean Precedex is approved for
use in pediatric patients. Precedex is only approved for use in adults aged 18
and older. The FDA is reviewing Hospira's pediatric studies of the product.
Additionally, Hospira received FDA approval for a premix version of Precedex,
which will provide clinicians a ready-to-use product with a number of benefits
for patient care.
"Hospira is excited about the approval of Precedex in a premix version that
will help reduce potential for medication errors, enhance patient safety and
increase pharmacy efficiency," said Thomas Moore, president, U.S., Hospira.
"This ready-to-use version of Precedex reinforces Hospira's dedication to
helping our customers better serve their patients."
The premix version of Precedex will be available to customers in the coming
weeks in 200mcg/50mL and 400mcg/100mL presentations.
Precedex is a relatively selective alpha-adrenergic agonist indicated for:
oSedation of initially intubated and mechanically ventilated patients
during treatment in an intensive care setting. Administer Precedex by
continuous infusion not to exceed 24 hours.
oSedation of non-intubated patients prior to and/or during surgical and
Precedex Important Safety Information
Precedex should be administered only by persons skilled in the management of
patients in the intensive care or operating room setting.
oMonitoring: Continuously monitor patients while receiving Precedex.
oBradycardia and sinus arrest: Have occurred in young healthy volunteers
with high vagal tone or with different routes of administration, e.g.,
rapid intravenous or bolus administration.
oHypotension and bradycardia: May necessitate medical intervention. May
be more pronounced in patients with hypovolemia, diabetes mellitus or
chronic hypertension, and in the elderly. Use with caution in patients
with advanced heart block or severe ventricular dysfunction.
oCo-administration with other vasodilators or negative chronotropic
agents: Use with caution due to additive pharmacodynamic effects.
oTransient hypertension: Observed primarily during the loading dose.
Consider a reduction in loading infusion rate.
oArousability: Patients can become aroused/alert with stimulation; this
alone should not be considered as lack of efficacy.
oProlonged exposure to dexmedetomidine beyond 24 hours may be associated
with tolerance and tachyphylaxis and a dose-related increase in adverse
oThe most common adverse reactions (incidence > 2%) are hypotension,
bradycardia and dry mouth.
For full prescribing information, please click here:
Hospira, Inc. is the world's leading provider of injectable drugs and infusion
technologies. Through its broad, integrated portfolio, Hospira is uniquely
positioned to Advance Wellness™ by improving patient and caregiver safety
while reducing healthcare costs. The company is headquartered in Lake Forest,
Ill., and has approximately 16,000 employees. Learn more at www.hospira.com
Private Securities Litigation Reform Act of 1995 --
A Caution Concerning Forward-Looking Statements
This press release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995, including statements
regarding the FDA's pediatric extension approval and premix approval of
Hospira's Precedex™. Hospira cautions that these forward-looking statements
are subject to risks and uncertainties that may cause actual results to differ
materially from those indicated in the forward-looking statements. Economic,
competitive, governmental, regulatory, legal, technological, manufacturing
supply, quality and other factors that may affect Hospira's operations and may
cause actual results to be materially different from expectations include the
risks, uncertainties and factors discussed under the headings "Risk Factors"
and "Management's Discussion and Analysis of Financial Condition and Results
of Operations" in Hospira's latest Annual Report on Form 10-K and subsequent
Forms 10-Q filed with the Securities and Exchange Commission, which are is
incorporated by reference. Hospira undertakes no obligation to release
publicly any revisions to forward-looking statements as the result of
subsequent events or developments.
SOURCE Hospira, Inc.
Contact: Media, Dan Rosenberg, +1-224-212-3366, or Financial Community, Ruth
Venning, +1-224-212-2711, or Karen King, +1-224-212-2711
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