copaxone fda approval

Companies that want to add to or change anything about a previous FDA approval must resubmit for a new approval and relabeling. That is why TEVA had to go through a new process to change Copaxone dosing from 20mg daily to 40mg three times a week. It's the same thing as happens when a drug is FDA approved and released to treat Thing One and is later found to be good for treating Thing Two. It's used "off-label" for Thing Two.

Another company is getting FDA approval for a generic of Copaxone which has been in production in India for two years. They will have to go through clinical trials in the U.S. Basically if you need Glatiramer Acetate, Copaxone, another company will have a generic at a lower price.

//www.haaretz.com/business/teva-scrambles-to-block-approval-for-biogen-s-copaxone-rival-1.

My Neurologist suggested I look in to taking Copaxone during the pregnancy to help cut down on the chance of relapse while trying to get pregnant and right after giving birth. Of course all the official documentation says don't take it, There is nothing but animal studies and human experience that suggests no negative effects for mom or baby. I am also on Oxybutonin for bladder control another Class B Drug. I was just wondering if any one had taken any thing while being pregnant.

The phase III trial for it just finished, and they plan to submit for FDA approval in the next few months. The FDA has already agreed to fast-track it, meaning they will hold hearings on its approval quickly after the application is submitted (rather than letting irt sit around for months). So, assuming the data from the trials looks good, it will probably be approved later this year or the beginning of next year.

m not sure how much stock can be placed in a desk reference that is 24 years old and published 6 years prior to a drug getting FDA approval. Basically no one had used it at that point bar very small numbers of participants on trials. I'm on a drug trial now myself and know full well that every little thing I mention gets documented in triplicate on the understanding that even a vague correlation will need to be reported when they approach the FDA for licensing.

The FDA must approve or disapprove of telaprevir on or before May 23 of this year. How long it will take to get on the drug formularies is something we do not know yet.

I've been on copaxone since June and it turned out to be easier to administer than I thought it would be. My neurologist told me last visit that it can take 6 months, but some people do see a difference in their symptoms. But again, that doesn't happen overnight, instead a several months. Now, don't ask Shared Solutions about that as the FDA did not give them approval to tout that it helps with symptoms.

Neurologist do not like to put you in [the PPMS category] because there are no FDA approved treatments for PPMS. Insurance companies do not have to pay for DMDs since they are not FDA approved." ~ "PPMS - how were you diagnosed?" http://www.medhelp.org/posts/Multiple-Sclerosis/PPMS---how-were-you-diagnosed/show/1235216 This is a good point, which I did not realize.

FDA Advisory Committee Unanimously Recommends Approval of Novartis Investigational Treatment FTY720 to Treat Relapsing Remitting MS -- Committee voted in favor of approval of FTY720 (fingolimod [now Gilenia]), as treatment in relapsing remitting multiple sclerosis, affirming the drugs positive benefit/risk profile -- FTY720, potentially first in a new class of MS therapy, represents a significant advance as an efficacious oral treatment for people with relapsing remitting MS -- Committee reco

I was offered to apply for the study, but I am going to wait for the approval from the FDA.

The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. Approval of a drug based on such endpoints is given on the condition that post marketing clinical trials verify the anticipated clinical benefit. The FDA bases its decision on whether to accept the proposed surrogate endpoint on the scientific support for thatendpoint.

You can thank our FDA for this delay. Here is an example of how their drug approval process kills thousands of people each year! http://www.lef.org/magazine/mag2010/nov2010_FDA-Delay-of-One-Drug-Causes-Lost-Life-Years_01.

s in the form of fingolimod and cladribine are in there final phases of trials and are awaiting FDA approval. We may even see fingliomod before the year is out. I think this is amazing! injectables are tough work no matter how long your on them or how often you take them. There is something incredibly appealing about not having a sharps bin in my house, needles in my fridge, and an autoject or 2 hanging around. To me personally these are constant reminders that I have MS.

//www.businessweek.com/news/2013-01-10/teva-cites-bg-12-safety-in-asking-fda-to-add-ms-reviews Make of it what you will....

shutdown did not affect the timeline for approval. The PDUFA decision date for sofosbuvir is December 8 or 9 depending on where you look. The overall tone of this document is very encouraging for a swift approval. As a genotype 2 hoping for the all oral treatment ASAP this is very good news. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM371877.pdf?

Each drug trial and treatment requires an approval from the FDA, to the best of my knowledge. In that regard, the FDA so far as Vertex may approval a plan for treating naives, a separate plan for treating past TX failures, and I assume there is one for co-infected (HCV &HIV) as well. Right now there is a current trial for BID dosing, but approval will be based on 3X daily and at some point twice daily may see an additional application.

Vertex has begun the application process for approval with the fda. The process should be completed by the end of this year with approval coming shortly after that. The results are promising and I believe the fda is going to put it on the fast track for approval. My doctor told me 6 months ago it will be probably be ready by the end of 2010. Like pcds says though, there is no way to know for sure. It may be sometime in 2011 before it is available. Hang in there!

While you can get your insurance companies to approve the treatment it still has not been approved by the FDA for ovca and my guess is since the fda has pulled their approval for breast cancer, it may be unlikely approved for ovca. I just finished cycle 4 of Avastin and am considering a change to another treatment option. I have had dibilitating headaches from Avastin. As well, I feel like my body and mind are racing....very anxious.

Because of my persistence, I received three phone calls from the FDA today. I'm going to now present you with the clarity of what's about to happen with the "Rolling NDA" (New Drug Application) from Vertex and other pharmaceutical companies. A Rolling NDA is an application to have the FDA put this drug on a “Priority Approval” as opposed to a “Standard Approval”. Here's the difference.

It is in the Teva study designs and there New Drug Approval (NDA) Application to the FDA . There was a concern about over activating the immune system in one area of the body and the chance of increased reactions, so they designed the original subcutaneous patterns to avoid over injection in any one area. This pattern also reduces the incidence of lipoatrophy. There have been several studies done by Teva for IM vs.

ve been following BG12 and the majority of the mentions of its efficacy and forward path in the FDA approval process does seem to come from the financial advisers who rate stocks as to whether investors should buy, hold or sell. Right now they are all saying either buy or hold with Biogen Idec, because of the promise that BG12 will make lots of money. There may be some new news on BG12 in the ECTRIMS video links I just posted. That would give the medical perspective.

Copaxone fda approval

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