Treatment News : Crofelemer for HIV Diarrhea Delayed Again by FDA

POZ - Health, Life and HIV
Subscribe to:
POZ magazine
Join POZ: Facebook MySpace Twitter Pinterest
Tumblr Google+ Flickr MySpace
POZ Personals
Sign In / Join

Back to home » Treatment News » September 2012

Most Popular Links
Most Popular Lessons

The HIV Life Cycle


Herpes Simplex Virus

Syphilis & Neurosyphilis

Treatments for Opportunistic Infections (OIs)

What is AIDS & HIV?

Hepatitis & HIV

20 Years Ago In POZ

More Treatment News

Click here for more news

Have news about HIV? Send press releases, news tips and other announcements to


September 6, 2012

Crofelemer for HIV Diarrhea Delayed Again by FDA

The U.S. Food and Drug Administration (FDA) has again postponed a decision on approving crofelemer, a compound made from the sap of the Peruvian Dragon’s Blood tree for the treatment of diarrhea in people living with HIV receiving antiretroviral therapy, according an announcement by  Salix Pharmaceuticals. Originally scheduled to be approved on June 5, 2012, the FDA informed Salix in April that it required more time to review the company’s new drug application (NDA) for the 125 mg tablets. On September 5, the revised approval date, Salix announced that the agency required more time to review the NDA. “The primary topic is the production and control of the crofelemer active pharmaceutical ingredient, a complex mixture that is the first botanical product to be reviewed by the Agency for oral use,” the September 5 Salix announcement explained. The company now anticipates an action by the FDA by the end of the March 2013.

To read the September 5 Salix news announcement, click here.

Search: crofelemer, diarrhea, dragon's blood tree, hiv, fda, approval, salix

Scroll down to comment on this story.


(will display; 2-50 characters)


(will NOT display)


(will display; optional)

Comment (500 characters left):

(Note: The POZ team reviews all comments before they are posted. Please do not include either ":" or "@" in your comment. The opinions expressed by people providing comments are theirs alone. They do not necessarily reflect the opinions of Smart + Strong, which is not responsible for the accuracy of any of the information supplied by people providing comments.)

Comments require captcha.
Please enter this number for verification:

| Posting Rules

Show comments (1 total)

[Go to top]

Facebook Twitter Google+ MySpace YouTube Tumblr Flickr Instagram
Quick Links
Current Issue

HIV Testing
Safer Sex
Find a Date
Newly Diagnosed
HIV 101
Disclosing Your Status
Starting Treatment
Help Paying for Meds
Search for the Cure
POZ Stories
POZ Opinion
POZ Exclusives
Read the Blogs
Visit the Forums
Job Listings
Events Calendar
POZ on Twitter

Ask POZ Pharmacist

Talk to Us
Has a pet helped you deal with your HIV?


more surveys
Contact Us
We welcome your comments!
[ about Smart + Strong | about POZ | POZ advisory board | partner links | advertising policy | advertise/contact us | site map]
© 2016 Smart + Strong. All Rights Reserved. Terms of use and Your privacy.
Smart + Strong® is a registered trademark of CDM Publishing, LLC.