Betaseron fda approval

Common Questions and Answers about Betaseron fda approval

betaseron

Avatar f tn 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.
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.
572651 tn?1530999357 Hi everyone, I mentioned in a thread with Julie, that Copaxone has been approved by the FDA to use in people with Clinically Isolated Syndrome. She was very interested and I posted the links there. But in case you don't see that post, I thought it would be good to start a new discussion here. This news was released by TEVA, the mfg. of Copaxone, in early March. http://www.medicalnewstoday.com/articles/141213.
Avatar m tn I was dx in march I'm now on betaseron, but I'm about to switch to aubagio. Is there anyone that's has been on it and how does it make you feel?
790496 tn?1315615657 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.
Avatar f tn I was offered to apply for the study, but I am going to wait for the approval from the FDA.
1831849 tn?1383228392 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.
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.
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!
Avatar f tn I started it in July of this year after giving Betaseron a try. My life became a living h*ll on Betaseron. It was definitely not the drug for me. My doctor went over all of my options, but at that point trying another shot was not going to happen. Ty I would never even consider since I have children to raise. Anyway, I knew going into the appt that I wanted to try LDN and was prepared for a fight to get an RX for it.
Avatar f tn I am 45. I've had RRMS for 20 yrs. Ihave had SPMS for 5 yrs(?). I am EDSS 8 or more. I'm on LDN, baclofen, (alertec) midafinil, 4 aminopyridine. I'm off betaseron now for about a year because I can't get funding because apparently I've progressed too far. Comments? Neuro and MSclinic just say "too bad..***** to be you". I see a feeding tube in my near future. My kids are 7 & 9. Any treatments to try and slow this thing down?
Avatar f tn For example, when a patient is proven to be so severely ill that he cannot wait for drug approval, how does the FDA and the manufacturer know for sure if the toxcity of the drug is due to the drug or the severe illness of the patient? It is possible that the drug would be perfectly safe for a Stage 2 patient but not a patient with late Stage 4. In the drug companies eyes, this is not in their best interest when they want to get a drug approved.