This Day On The Street
Continue to site
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

FDA Approves Teva’s SYNRIBO® (Omacetaxine Mepesuccinate) For Injection For Home Administration

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) today announced that the U.S. Food and Drug Administration (FDA) has approved SYNRIBO ® (omacetaxine mepesuccinate) for injection, for subcutaneous use, to include home administration, and also approved a related Medication Guide and Instructions for Use. With this approval, physicians who treat adults with chronic or accelerated phase CML who are no longer responding to, or who could not tolerate, two or more tyrosine kinase inhibitors (TKIs) will now have the option to allow their patients to administer SYNRIBO ® therapy at home. Teva is working to finalize a comprehensive specialty pharmacy support program which will help facilitate successful home administration of SYNRIBO ® for HCPs, their patients and caregivers. This program is expected to “go live” as early as possible in the second quarter of 2014.

“As we continue to expand our oncology portfolio and services at Teva, the updated labeling for SYNRIBO ® demonstrates our commitment to improving the overall experience and lowering barriers to treatment for people living with CML,” said Bill Campbell, Vice President and General Manager, Teva Oncology. “Home administration can reduce the number of required doctor office visits for patients being treated with SYNRIBO ®, while still maintaining close collaboration with their healthcare provider to manage their treatment regimen.”

“It had been necessary for adults living with chronic or accelerated phase CML who are prescribed SYNRIBO ® to travel to their doctor’s office twice a day for two weeks, which can be extremely burdensome and inconvenient to both patients and their caregivers,” said Meir Wetzler, MD, FACP, Chief of the Leukemia Section at Roswell Park Cancer Institute. “Now, physicians can decide if their patients are candidates for self administration, and if so, provide their patients with guidance on how to properly administer reconstituted SYNRIBO ® in the home.”

“As an oncology nurse practitioner who has treated CML patients for nearly 20 years, I’m thrilled to see this unique therapy become available for home administration,” said Sandra Corbin, CRNP at Calvert Hematology and Oncology. “Patients may initially express concern at the thought of self-injecting—but with training and support, most can become skilled at administering the subcutaneous injections.”

1 of 4

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
Only $9.95
14-Days Free
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
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free


Chart of I:DJI
DOW 17,114.82 -17.04 -0.10%
S&P 500 2,014.89 +15.91 0.80%
NASDAQ 4,824.8230 -13.82 -0.29%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs