Hospira, Inc. Obtains Six Months U.S. Pediatric Exclusivity for Precedex™ (dexmedetomidine HCl) Injection
Published: Mar 19, 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 200 mcg/50 mL and 400 mcg/100 mL presentations.
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
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.