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PostPosted: Sat Mar 28, 2009 3:04 pm 
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Joined: Thu May 25, 2006 6:29 pm
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Location: Davao City

Hepatitis A can be spread in fecally contaminated food and water, and symptoms include nausea, vomiting and sometimes jaundice, a yellowing of the skin due to reduced liver function.

Hepatitis B can be spread by infected blood or body fluids, such as during sexual contact, sharing IV needles, or by using contaminated equipment in body piercing or tattooing.

The US Food and Drug Administration approved a combination vaccine for hepatitis A and hepatitis B on November 12.

The Twinrix vaccine is the world's only combination vaccine for the prevention of hepatitis A and B. Hepatitis A and hepatitis B are viruses that infect the liver.

The approval is also especially important for Americans traveling overseas, who often are vaccinated for hepatitis A but not hepatitis B, she said.

Each year, an estimated 125,000 to 200,000 Americans are infected with hepatitis A and another 140,000 to 320,000 are infected with hepatitis B.

Twinrix currently is approved in 70 markets worldwide, including the European Union, where it was launched in 1996. Glaxo has distributed nearly 12 million doses.

Reuters Washington D.C., November 13, 2001

PostPosted: Wed Jul 22, 2009 3:16 pm 

Joined: Sat Jul 18, 2009 7:37 pm
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How do you file a supplement product with the FDA? I am planning to put out a product that has supplement ingredients in it for energy - an energy drink. Does anyone know what the process is for this with regards to the FDA? Is a supplement product like this considered a drug? Does it have its own category? Does anyone know what the filing process is with the FDA? The FDA's site is not particularly easy to understand, so I thank you for helping me out.


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