Tags: Cancer | cancer | generic | drug | Doxil | FDA | shortage

Cancer Generic Approved to Ease Life-Threatening Drug Shortage

Tuesday, 05 Feb 2013 07:40 AM

 

Share:
  Comment  |
   Contact Us  |
  Print  
|  A   A  
  Copy Shortlink
Health regulators have approved a generic version of the cancer drug Doxil in a move that could ease a months-long shortage that has threatened the lives of thousands of patients.
 
The Food and Drug Administration said on Monday it approved a version of Doxil, known generically as doxorubicin HCI liposome injection, that is made by Sun Pharma Global FZE, a subsidiary of India's Sun Pharmaceutical Industries Ltd. It will be available in 20-milligram and 50-milligram vials.
 
Sun's product is the first generic version of Doxil, which was approved in 1995 and is used to treat ovarian cancer, AIDS-related Kaposi's sarcoma, and multiple myeloma. Doxil is made by Johnson & Johnson.
 
Doxil fell into short supply after manufacturing problems at an outside contract manufacturer, Ben Venue Laboratories Inc, a unit of German drugmaker Boehringer Ingelheim, suspended operations in November 2011 due to quality control problems.
 
Last February, the FDA allowed for the temporary importation of Lipodox, which is made by Sun and contains the same active ingredient as Doxil. The agency said it intends to continue allowing the importation of Lipodox until Sun has made enough generic Doxil to meet demand.
 
Late last month a federal judge approved a consent decree under which Ben Venue must bring its Bedford, Ohio facility into compliance with regulatory requirements or face fines and other penalties.
 
The FDA said the company had repeatedly violated good manufacturing practices. Recent inspections found that poorly maintained equipment deteriorated to the point that it shed particles into injectable drugs, the FDA said.
 
President Barack Obama made drug shortages a national priority with an executive order in October, 2011.

© 2014 Thomson/Reuters. All rights reserved.

Share:
  Comment  |
   Contact Us  |
  Print  
  Copy Shortlink
Around the Web
Join the Newsmax Community
Please review Community Guidelines before posting a comment.
>> Register to share your comments with the community.
>> Login if you are already a member.
blog comments powered by Disqus
 
Email:
Country
Zip Code:
Privacy: We never share your email.
 
Hot Topics
Follow Newsmax
Like us
on Facebook
Follow us
on Twitter
Add us
on Google Plus
Around the Web
Top Stories
You May Also Like

Kids' Get Antibiotics Twice as Often as Needed: Study

Monday, 15 Sep 2014 17:09 PM

Pediatricians prescribe antibiotics about twice as often as they're actually needed for children with ear and throat inf . . .

Bald Men Have Higher Prostate Cancer Risk: Study

Monday, 15 Sep 2014 17:01 PM

Men with male pattern baldness may face a higher risk of developing an aggressive type of prostate cancer than men with  . . .

Drugmaker Agrees to Cheaper Versions of $1,000-a-Pill Hepatitis Med

Monday, 15 Sep 2014 16:51 PM

U.S. drugmaker Gilead Sciences Inc has licensed its hepatitis C drug Sovaldi to seven India-based drugmakers that will s . . .

Most Commented

Newsmax, Moneynews, and Independent. American. are registered trademarks of Newsmax Media, Inc. Newsmax TV, NewsmaxWorld, NewsmaxHealth, are trademarks of Newsmax Media, Inc.

 
NEWSMAX.COM
America's News Page
©  Newsmax Media, Inc.
All Rights Reserved