---
title: New Botulism Antitoxin set for FDA Approval
date: 2013-03-10T09:46:41-07:00
author: Bill Marler
canonical_url: "https://marlerclark.com/news_events/new-botulism-antitoxin-set-fro-fda-approval"
section: News
---
[All News](/news_events) / [Outbreaks](https://marlerclark.com/news_events/outbreaks) /

# New Botulism Antitoxin set for FDA Approval

 

 

 A committee of advisors to the U.S. Food and Drug Administration has given its stamp of approval to an antitoxin designed to treat patients with botulism.

In a unanimous decision announced last week, the 18-member Blood Products Advisory Committee voted to recommend the heptavalent botulinum antitoxin (HBAT), developed by a Canadian pharmaceutical company, to the federal agency for approval.

HBAT is the only botulinum antitoxin currently available for use in the U.S. It is currently an investigational product controlled by the Centers for Disease Control and Prevention. Doctors must seek approval from CDC in order to administer HBAT to patients.

The antibodies contained in HBAT target all seven known types of botulinum toxins, which attack the nervous system of infected individuals and can cause paralysis or even death.

These neurotoxins infect humans through wounds or contaminated food, and have also been identified as a potential agent of biological warfare.

The drug, developed by Cangene Corporation of Fort Garry, Winnipeg, works to prevent internalization of the toxin in the nerves.

It was used on 148 patients in the U.S. between January of 2008 and December of 2012 at part of CDC’s trial program, according to the company’s briefing document for the committee. Adminisration of HBAT within two days of symptom onset significantly reduced the duration of hospitalization for patients.

FDA will decide whether to approve HBAT for licensing, under the proprietary name BAT™, in March of this year.

  

### Other Botulism Lawsuits

 [By Heart Infant Formula tied to Botulism Outbreak spikes to 51](https://marlerclark.com/by-heart-infant-formula-tied-to-botulism-outbreak)

 [Botulism Outbreak at Valley Oak Food and Fuel](https://marlerclark.com/botulism-outbreak-at-valley-oak-food-and-fuel)

 [Marler Clark Files Two Botulism Lawsuits](https://marlerclark.com/marler-clark-files-two-botulism-lawsuits)

 

 

 

### Lawsuit updates about foodborne illnesses

 [Reactive Arthritis Lawsuit Updates](/news_events/case-news?illness=reactive-arthritis&year=all)

 [E. coli Lawsuit Updates](/news_events/case-news?illness=e-coli&year=all)

 [Guillain-Barre Syndrome Lawsuit Updates](/news_events/case-news?illness=guillain-barre-syndrome&year=all)

 [Salmonella Lawsuit Updates](/news_events/case-news?illness=salmonella&year=all)

 [Hemolytic Uremic Syndrome Lawsuit Updates](/news_events/case-news?illness=hemolytic-uremic-syndrome&year=all)

 [Listeria Lawsuit Updates](/news_events/case-news?illness=listeria&year=all)

 [Irritable Bowel Syndrome Lawsuit Updates](/news_events/case-news?illness=irritable-bowel-syndrome&year=all)

 [Hepatitis A Lawsuit Updates](/news_events/case-news?illness=hepatitis-a&year=all)

 [Norovirus Lawsuit Updates](/news_events/case-news?illness=norovirus&year=all)

 [Botulism Lawsuit Updates](/news_events/case-news?illness=botulism&year=all)

 [Campylobacter Lawsuit Updates](/news_events/case-news?illness=campylobacter&year=all)

 [Shigella Lawsuit Updates](/news_events/case-news?illness=shigella&year=all)

 [Cyclospora Lawsuit Updates](/news_events/case-news?illness=cyclospora&year=all)

 

 

### Lawsuits updates by year

 [Foodborne Illness Lawsuits in 1998](https://marlerclark.com/news_events/case-news?illness=all&year=1998)

 [Foodborne Illness Lawsuits in 1999](https://marlerclark.com/news_events/case-news?illness=all&year=1999)

 [Foodborne Illness Lawsuits in 2000](https://marlerclark.com/news_events/case-news?illness=all&year=2000)

 [Foodborne Illness Lawsuits in 2001](https://marlerclark.com/news_events/case-news?illness=all&year=2001)

 [Foodborne Illness Lawsuits in 2002](https://marlerclark.com/news_events/case-news?illness=all&year=2002)

 [Foodborne Illness Lawsuits in 2003](https://marlerclark.com/news_events/case-news?illness=all&year=2003)

 [Foodborne Illness Lawsuits in 2004](https://marlerclark.com/news_events/case-news?illness=all&year=2004)

 [Foodborne Illness Lawsuits in 2005](https://marlerclark.com/news_events/case-news?illness=all&year=2005)

 [Foodborne Illness Lawsuits in 2006](https://marlerclark.com/news_events/case-news?illness=all&year=2006)

 [Foodborne Illness Lawsuits in 2007](https://marlerclark.com/news_events/case-news?illness=all&year=2007)

 [Foodborne Illness Lawsuits in 2008](https://marlerclark.com/news_events/case-news?illness=all&year=2008)

 [Foodborne Illness Lawsuits in 2009](https://marlerclark.com/news_events/case-news?illness=all&year=2009)

 [Foodborne Illness Lawsuits in 2010](https://marlerclark.com/news_events/case-news?illness=all&year=2010)

 [Foodborne Illness Lawsuits in 2011](https://marlerclark.com/news_events/case-news?illness=all&year=2011)

 [Foodborne Illness Lawsuits in 2012](https://marlerclark.com/news_events/case-news?illness=all&year=2012)

 [Foodborne Illness Lawsuits in 2013](https://marlerclark.com/news_events/case-news?illness=all&year=2013)

 [Foodborne Illness Lawsuits in 2014](https://marlerclark.com/news_events/case-news?illness=all&year=2014)

 [Foodborne Illness Lawsuits in 2015](https://marlerclark.com/news_events/case-news?illness=all&year=2015)

 [Foodborne Illness Lawsuits in 2016](https://marlerclark.com/news_events/case-news?illness=all&year=2016)

 [Foodborne Illness Lawsuits in 2017](https://marlerclark.com/news_events/case-news?illness=all&year=2017)

 [Foodborne Illness Lawsuits in 2018](https://marlerclark.com/news_events/case-news?illness=all&year=2018)

 [Foodborne Illness Lawsuits in 2019](https://marlerclark.com/news_events/case-news?illness=all&year=2019)

 [Foodborne Illness Lawsuits in 2020](https://marlerclark.com/news_events/case-news?illness=all&year=2020)

 [Foodborne Illness Lawsuits in 2021](https://marlerclark.com/news_events/case-news?illness=all&year=2021)

 [Foodborne Illness Lawsuits in 2022](https://marlerclark.com/news_events/case-news?illness=all&year=2022)

 [Foodborne Illness Lawsuits in 2023](https://marlerclark.com/news_events/case-news?illness=all&year=2023)

 [Foodborne Illness Lawsuits in 2024](https://marlerclark.com/news_events/case-news?illness=all&year=2024)

 [Foodborne Illness Lawsuits in 2025](https://marlerclark.com/news_events/case-news?illness=all&year=2025)

 [Foodborne Illness Lawsuits in 2026](https://marlerclark.com/news_events/case-news?illness=all&year=2026)

 

 

 

##### Get Help

   

#### Affected by an outbreak or recall?

The team at Marler Clark is here to answer all your questions. Find out if you’re eligible for a lawsuit, what questions to ask your doctor, and more.

 [ Get a free consultation ](https://marlerclark.com/contact) 

##### Related Resources

   

 

######  [What is Botulism?](https://marlerclark.com/foodborne-illnesses/botulism/what-is-botulism) 

Botulism is a life-threatening paralytic illness caused by neurotoxins produced by an anaerobic, gram-positive, spore-forming bacterium—Clostridium botulinum. Botulism is a rare disease and only affects a few hundred persons each...

 

######  [Epidemiology and Microbiology of Botulism](https://marlerclark.com/foodborne-illnesses/botulism/epidemiology-and-microbiology-of-botulism) 

C. botulinum bacteria and spores are widely distributed in nature because they are indigenous to soils and waters. They occur in both cultivated and forest soils, bottom sediment of streams...

 

######  [Symptoms of Botulism](https://marlerclark.com/foodborne-illnesses/botulism/symptoms-of-botulism) 

After their ingestion, botulinum neurotoxins are absorbed primarily in the duodenum and jejunum, pass into the bloodstream, and travel to synapses in the nervous system. There, the neurotoxins cause flaccid...

 

######  [Detection and Treatment of Botulism](https://marlerclark.com/foodborne-illnesses/botulism/detection-and-treatment-of-botulism) 

Although botulism can be diagnosed based on clinical symptoms, distinguishing it from other diseases is often difficult, especially in the absence of other known persons affected by the condition. Common...

 

######  [Botulism Outcomes and Long-Term and Permanent Injury](https://marlerclark.com/foodborne-illnesses/botulism/botulism-outcomes-and-long-term-and-permanent-injury) 

In the past 50 years, mortality from botulism has fallen dramatically (from about 50% to 8%) because of advances in supportive care, which is the mainstay of treatment. The respiratory...

 

##### Outbreak Database

   

#### Looking for a comprehensive list of outbreaks?

The team at Marler Clark is here to answer all your questions. Find out if you’re eligible for a lawsuit, what questions to ask your doctor, and more.

 [ View Outbreak Database

  ](https://outbreakdatabase.com)
