colesevelam fda

Londres is certainly correct that there are a few other options available to treat what could be assumed to be familial hypercholesterolaemia, even though your doctor has obviously tried those that would be most obvious. Generally, if you experience muscle weakness as a side effect of Lipitor (atorvastatin), other statins will produce similar effects, so that eliminates the use of Zocor (simvastatin), Crestor (rosuvastatin) etc.

s complications such as pancreatic insufficiency, for which I take Creon enzymes with each meal, and Colesevelam for bile salts. We cannot prescribe any drugs as a lot of them are toxic, and can only be prescribed by a Gastroenterologist. I would suggest you have a consultation with your own gastro and heed his advice - they are the experts, not us! Take care, Liz.

Fda, getting movin! I have already written to my senators congressional rep , people will decompensate and probably die while we are waiting for sofo/ledip/sime.

That's pretty standard of the FDA, they do this all the time (in other words, it's not earth shattering). Law requires any claims at cures (or more precisely 'treatment') be backed up by clinical trials, FDA clinical trials to be precise. That is why nobody can say any drug, supplement, etc, is a treatment or cure without first completing a multi-million dollar FDA clinical trial that will last for 10 to 20 years.

Today I got not one but two calls from the FDA, so apparently my persistence is paying off. They are going to do whatever the pharmaceutical companies suggest, especially since there are no other alternative drugs except Interferon and Ribavirin. My contact at Vertex, who I just spoke to, is going to look once more into the IND application (Compassionate Use), and see if there's been any changes in their (Vertex) policy for allowing it.

Daily visits to selected websites, subscriptions to selected scientific and medical podcast as well as my monthly magazines such as Nature, Scientific American, Physics Today, Science Magazine and Science Readers. respirate just convinced me to add the FDA website into my dailies. What is good with technology these days is that you can be very selective regarding the kind of information you want to get and newspapers make me angry for some reasons that are totally personal.

I don't know if I can forward this link but evidently there is a fda warning re: possible salmonella in raw tomatoes. I'll try to copy and paste link, but if it doesn't work, go to the FDA website. I know that some of my friends having chemo had to be very careful when eating raw fruits or vegetables. Just thought I'd pass it along. I heard this on CNN as well. It's not a hoax...http://www.fda.gov/bbs/topics/NEWS/2008/NEW01848.

GILD), with a proposed indication for the treatment of chronic hepatitis C infection, in combination with other agents in adult patients with genotypes 1 to 6 and/or adult patients awaiting liver transplantation. FDA intends to make background material available to the public no later than 2 business days before the meeting.

The FDA has issued a stern warning concerning the use of Advair. Not only can it worsen asthma, but the side effects can be fatal. Other forms of treatment should be sought and, if the product is used at all, it should be for short periods of time. Advair affected my adrenals, harmed my eyes, and worsened my asthma. It caused such serious choking that I feared it would kill me. I stopped taking it last August and am doing fine on natural anti-inflammatories.

For people with 1b Sovaldi and Riba seems to be the ticket. Later this year the FDA should approve the companion drug for Sovaldi and do away with the Riba. Do you know what your IL28B Polymorphism is? You could wait until later this year and do the 2 drug combo or do Sovaldi and riba now.

ALL ELISA tests are FDA approved. All tests marketed in the US are FDA approved. All tests are 3 month tests to obtain a conclusive negative test result. Now move on.

At the close of the inspection, the FDA investigator presented an inspectional observations Form FDA 483 for your review and discussed the observations listed on the form with you. The deviation noted on the Form FDA 483, your written response to the noted violation dated November 7, 2011,and our subsequent review of the inspection report is discussed below. This letter also requests prompt corrective action to address the violation cited.

Here is the information I received today from both RLC labs ( the makers of Naturethroid) and the FDA. YES!!! - I really talked to a live person with both of them:) Now remember - this is ONLY the most up to date information I have. It sounded a bit hairy on the phone with the FDA - but I'll explain below. First - both organizations were the best people I have spoken to in a long time. 1. RLC labs....... "There is NO ceasing of desiccated thyroid medication.

The FDA is accepting comments regarding expanded access to the Direct acting anti-virals for Hep C at http://www.regulations.gov/search/Regs/home.html#submitComment?R=0900006480ab98ce. Will those of us who cannot or will not take interferon post comments demanding greatly expanded trials with combinations of the best STAT-C drugs, in the public health interest?

IDX719 Receives Fast Track Designation From the FDA for the Treatment of Chronic Hepatitis C Infection CAMBRIDGE, Mass., July 25, 2012 (GLOBE NEWSWIRE) -- Idenix Pharmaceuticals, Inc. (Nasdaq:IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for IDX719 for the treatment of chronic hepatitis C infection (HCV).

Vertex asked for fast track status several years ago. The FDA made them add another trial. The point I was trying to make along with the article is that the FDA approval process STINKS and cost many people their lives! If a drug is proven safe and tested then there is no reason you should have to wait 8-10 years to be approved. All this does is make the drugs cost more money.

No the military would not use a test that is not FDA approved. For further discussions on this I suggest you talk with your medic.

remedy for the treatment of anxiety, stress, insomnia, etc. Since it is not technically a drug it does not go through the FDA approval process. I always suggest being extremely careful when purchasing 'non-traditional' remedies, meds, etc. Do you have an aversion to using Antidepressants? Some people choose not to use them, which is fine, however, they are available by prescription and have been vetted through the FDA approval process.

s the difference. A Standard Approval (by the FDA) means that the maximum amount of time the FDA can take in approving a new drug is 10 months. A Priority Approval means the FDA has to either approve or not approve a new drug within a maximum amount of time no greater than 6 months. Vertex is submitting a Rolling NDA for Telaprevir. This means that if they file for it with the FDA this month, it can be approved by the end of this year and we could initially get the drug in January, 2011.

Colesevelam fda

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