This Day On The Street
Continue to site right-arrow
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
Cramer's Action Alerts PLUS - See his portfolio and get alerts BEFORE every trade. Learn more NOW!

Hospira Obtains Six Months U.S. Pediatric Exclusivity For Precedex™ (dexmedetomidine HCl) Injection

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 alpha 2-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.

Copyright 2011 PR Newswire. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Try it NOW
Only $9.95
Try it NOW
14-Days Free
Try it NOW

Check Out Our Best Services for Investors

Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
Try it NOW
Try it NOW
Try it NOW
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
SYM TRADE IT LAST %CHG

Markets

DOW 18,103.83 -99.54 -0.55%
S&P 500 2,097.76 -10.02 -0.48%
NASDAQ 4,966.55 -13.3510 -0.27%

Partners Compare Online Brokers

Free Reports

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs