Mycophenolate mofetil fda approval

Common Questions and Answers about Mycophenolate mofetil fda approval

cellcept

778275 tn?1326913623 I can sort of answer your first question. Mycophenolate mofetil (MMF) or Cellcept has been extensively researched for its use in myasthenia gravis. Also, it carries a FDA black box warning that it may increase your chances of infection, lymphoma and congenital malformations (for pregnant women). Also, its optimal dose is yet undecided. Pyridostigmine (Mestinon) is the usual first line treatment for MG.
Avatar m tn The standard therapy options include intravenous immunoglobulin and plasmapharesis, corticosteroids, azathioprine, cyclophosphamide, etanercept, mycophenolate mofetil, interferon alpha 2a and tacrolimus. Current ones are interferon beta 1a, rituximab, and high dose cyclophosphamide. Your neurologist needs to apprise you of the long-term side effects since prolonged therapy are required. Botox shots are not known to be used in therapy.
Avatar f tn I am not on Cellcept which is Mycophenolate Mofetil 1g morning and 1g night. This is a fantastic immunposuppressant. Basically what I am telling you is that at any time your body cannot any longer tolerate one drug, there is always another waiting. The one I am on now is more 'pure' in other words there are less chemicals in in to effect the liver. It might be worth a mention if you are uncertain but many people are able to tolerate your medication for many years.
Avatar m tn Hi, glad you have been diagnosed, this can often get misses as indeed mine was for some time. I have PBC aswell which was what I was diagnosed with first. I agree that you should always check on other suppliments. I only take cod liver oil tablets as a supplement with my meds. Just a thought though, if you ever feel unwell on your meds, please do not be afraid to challenge your doc. I took mine as instructed and became so ill.
Avatar n tn Also, I have IgA nephropathy and have been on low dose immunosuppressant (mycophenolate mofetil 250 mg twice daily) for the past 1.5 years. 4 days ago, I noticed a little bump in on my labia minora. and I thought maybe it was a boil and tried to break it. It is now pus filled and looks like a zit. its just the one. I have no tingling or itching tho there is some pain now after i messed abt with it which is kinda like the pain i feel with zits anywhere.
962117 tn?1416358616 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.
Avatar f tn I was offered to apply for the study, but I am going to wait for the approval from the FDA.
Avatar f tn 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.
789572 tn?1334424879 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.
Avatar m tn 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?
29837 tn?1414534648 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.
4848471 tn?1372238752 I was JC+ before I even started Tysabri and am about one and a half years into it now, still taking it..............I talked to the Tysabri regional rep about it and they still feel our chances of PML are very low.
Avatar n tn I am on 750 urso three times a day now.. I am 52. I am now on Cellcept (mycophenolate Mofetil) 1g twice daily. This is because the other meds like Azathioprine and Mercaptopurine disagreed with me intensely and I turned a beautiful shade of butterscotch and was oh so ill. This new drug has less chemicals in and suits me very well, in fact I walked 6 miles in Jordan as opposed to not even being able to get out of bed.
Avatar f tn 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!
107366 tn?1305680375 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.
29837 tn?1414534648 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.
585414 tn?1288941302 Update. The medication was FDA approved recently and will be available next year. http://www.medscape.com/viewarticle/731619 " FDA Approves Once-Daily Lurasidone for Schizophrenia Yael Waknine October 29, 2010 — The US Food and Drug Administration (FDA) has approved the atypical antipsychotic lurasidone (Latuda tablets; Sunovion Pharmaceuticals Inc) for the once-daily treatment of patients with schizophrenia...
550739 tn?1224163372 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. In dealing with this have you ever talked about this with a therapist? I am a big proponent of talk therapy...while meds are great tool to use, I believe they are by no means a magic pill; but combined with education about why you think the way you do, it can be a very powerful tool in thriving with this....keep us posted!