A Smart + Strong Site
Subscribe to:
Newsletters
POZ magazine
JOIN AIDSMEDS YouTube

Back to home » Treatment News » Top Stories

Most Popular Stories
Undetectable Viral Load Essentially Eliminates Transmission Risk in Straight Couples
FDA Approves New Single-Tablet HIV Regimen, Triumeq
Life Expectancy for Young People With HIV Is Nearly Normal
A 15-Year Jump in Life Expectancy for People With HIV
Scientists Devise Method of Snipping HIV From Immune Cells
Monkey HIV Vaccine Success Opens Door for Human Trials
HIV Combo Pill Less Toxic Thanks to New Form of Tenofovir
What's That Mean?
(just double-click it!)

If you don't understand one of the words in this article, just double-click it. A window will open with a definition from mondofacto's On-line Medical Dictionary. If the double-click feature doesn't work in your browser, you can enter the word below:

Most Popular Lessons
Aging & HIV
The HIV Life Cycle
Shingles
Herpes Simplex Virus
Syphilis & Neurosyphilis
Treatments for Opportunistic Infections (OIs)
What is AIDS & HIV?
More News

Have medical or treatment news about HIV? Send press releases, news tips and other announcements to news@aidsmeds.com.

Click here for more news


emailprint

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.



Name:

(will display; 2-50 characters)

Email:

(will NOT display)

City:

(will display; optional)

Comment (500 characters left):

(Note: The AIDSmeds team reviews all comments before they are posted. Please do not include ":" "@" "<" ">" 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]

Quick Links
About HIV and AIDS
The Cure
Lab Tests
Clinical Trials
HIV Meds
Starting Treatment
Switching Treatment
Drug Resistance
Side Effects
Disclosure
Lipodystrophy
Hepatitis & HIV
Women & Children
Fact Sheets
Treatment News
Community Forums
Blogs
Conference Coverage
Health Services Directory
POZ Magazine


    adorableone
    New York
    New York


    Newhopenate
    New Hope
    Pennsylvania


    Deelight4u
    BROOKLYN
    New York


    clintonjrsyr
    syracuse
    New York
Click here to join POZ Personals!
Conference Coverage

XX International AIDS Conference
(AIDS 2014)
Melbourne, Australia
July 20 - 25, 2014


21st Conference on Retroviruses and Opportunistic Infections
(CROI 2014)
Boston, MA
March 3 - 7, 2014


7th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention
(IAS 2013)
Kuala Lumpur, Malaysia
June 30 - July 3, 2013


more conference coverage

[ about AIDSmeds | AIDSmeds advisory board | our staff | advertising policy | advertise/contact us]
© 2014 Smart + Strong. All Rights Reserved. Terms of use and Your privacy.
Smart + Strong® is a registered trademark of CDM Publishing, LLC.