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 200 mcg/50 mL and
400 mcg/100 mL presentations.
Precedex Indications
Precedex is a relatively selective alpha2-adrenergic
agonist indicated for:
- Sedation of initially intubated and mechanically ventilated
patients during treatment in an intensive care setting. Administer
Precedex by continuous infusion not to exceed 24 hours.
- Sedation of non-intubated patients prior to and/or during
surgical and other procedures.
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.
- Monitoring: Continuously monitor patients while receiving
Precedex.
- Bradycardia 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.
- Hypotension 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.
- Co-administration with other vasodilators or negative
chronotropic agents: Use with caution due to additive
pharmacodynamic effects.
- Transient hypertension: Observed primarily during the
loading dose. Consider a reduction in loading infusion rate.
- Arousability: Patients can become aroused/alert with
stimulation; this alone should not be considered as lack of
efficacy.
- Prolonged exposure to dexmedetomidine beyond 24 hours may be
associated with tolerance and tachyphylaxis and a dose-related
increase in adverse events.
- The most common adverse reactions (incidence > 2%) are
hypotension, bradycardia and dry mouth.
For full prescribing information, please click here:
http://www.precedex.com/wp-content/uploads/Precedex_PI.pdf
About Hospira
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.