Rebif new formulation fda

Common Questions and Answers about Rebif new formulation fda

rebif

382218 tn?1341181487 Thanks All, for the comments and suggestions. I am not too worried about it, just want to make sure I'm not doing anything wrong. It sounds like I'm not, which is good! Gollie, you are correct, the Rebiject is for Rebif. I do ensure that I pull the cap off straight, so as not to bend the needle. I use the highest setting; at least I think it's the highest. The one that goes the deepest into the skin. On Rebiject the settings are 1 - 3. I use 3.
560501 tn?1383612740 Earlier Phase 2 studies showed that treatment with alemtuzumab reduced the accumulation of disability and the frequency of relapses in people with early relapsing-remitting MS, compared to Rebif® (interferon-beta-1a-rebif/index.aspx, interferon beta-1a, EMD Serono, Inc. and Pfizer, Inc.). (New England Journal of Medicine 2008 359;17:30-45) Rebif is a registered trademark of EMD Serono, Inc. and Pfizer, Inc. http://www.nationalmssociety.org/news/news-detail/index.aspx?
422172 tn?1215990852 When I was dx'ed last fall my neuro gave me info on 3 studies: Rebif New Formulation vs placebo; efficacy of combining Avonex and Copaxone; and a natural history study, as an adjunct to the Avonex/Copaxone study. I declined all of them as I live about 450 kms from the research facility and being in a study involves monthly follow ups. Winter was around the corner, I was overwhelmed by my dx, and did not want to make a commitment to be doing all that travel.
1936411 tn?1333831849 That ***** Jane!!! I totally agree and I also hate change. My rebif nurse keeps trying to make me switch to a new autoinjecter that retracts. I like what I have now thank you ! :) Call shared solutions, I'm sure they can send you something different :).
Avatar n tn A while after it was reformulated, the FDA stopped production and shipments for several months, many people switched to other brands at that time and never went back. I used the new formulation for several months before it became unavailable nation wide. It is believed that the new formula which uses micro crystalline cellulose as a filler (Nature Throid changed to that as well), makes the hormone not absorb as well.
Avatar n tn Hi I noticed a lot of comments on the "New" formulation of the Armour Thyroid tablets. I never got pills from my pharmacy with the "A" I swear all of mine were blank with no logo. I noticed this last batch has the "A" logo, is whiter and does not split in half well at all. Were there Armour tablets with no logo before? I am so confused and upset by this whole problem with this medication. I feel like buying a pig farm and learning how to make the stuff myself.
Avatar n tn The answer is no, however the differences are probably not clinically significant. Valium is a brand name. Not a generic name. The generic name is diazapam. The FDA will usually provide a history of changes, although some may be proprietary. You ask an interesting question. Many "common" drugs have actually changed in formulation several times. Synthroid, for example, has changed it's formulation several times since introduction.
1116556 tn?1345115906 Hi, I was so happy to read the news but, I'm currently on Rebif, so I don't see a reason to switch, only thing is no injecting..... And rebif does not have the hair loss, and fatal liver damage warning ....
Avatar m tn Tenofovir alafenamide (TAF), a new formulation that reaches higher levels in cells but allows for lower dosing, was as effective as the current tenofovir disoproxil fumarate (TDF) formulation but had less impact on markers of kidney function and bone turnover, researchers reported at the 53rd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC 2013) this week in Denver.
1149087 tn?1415316549 thanks for making feel welcome x problem is that i really want to just trust in what my neuro is doing, i do feel taken very seriously by him and i also can tell that he does care about every single one of his patients including myself. he mentioned something about a new formulation of rebif, but not sure if that is likely to change the side effects. i guess i am already quite depressed again-suppose crying is a pretty good indication, as i'm otherwise not so prone to that.
Avatar f tn Has anyone heard of the new medicine for hep C? Or is going through the new treatment themselves?
Avatar m tn We have evaluated the potential of a novel vaccine formulation comprising particulate hepatitis B surface (HBsAg) and core antigen (HBcAg), and the saponin-based ISCOMATRIX™ adjuvant for its ability to stimulate T and B cell responses in C57BL/6 mice and its ability to break tolerance in syngeneic HBV transgenic (HBVtg) mice.
Avatar n tn May not be available for along time,who knows??? We were not doing well on the new formulation of Armour( weird HYPO symptoms and blood work off after our last refill) anyway and had already switched to Naturethroid 5 weeks ago. However, they are having supply/demand issues and it is also hard to find. They will have supplies filled in aprox. 90 days. You can have compounded dessicated in your MG to hold you over until then. Naturethroid is working great here. You should try it when you can.
Avatar n tn I have heard a lot of people complain about the new formulation of Oxycontin .It is called OP I think .Purdue made this new formulation to stop people from abusing it but I have heard a lot of CP patients complain that it doesn't work as good as the old formulation .There is a substance that turns to a gel to keep people from snorting it or shooting it up and that may be what is causing it to not dissolve correctly .That's my best guess about it though .I would talk to my Dr about this .
Avatar f tn I saw my neurologist and he said that becuase I had recently had an increase in dosage of rebif it could be making me feel unwell. My symptoms were painful spacticity and urinary difficult (which were all new to me) and I'd swear I was having a relpase. I felt sicker than ever before with MS.
645800 tn?1466860955 He told me he is expecting a new treatment will be approved later this year by the FDA. It is a infusion every 6 months. Of course I cant remember the name for the drug and have not been able to find any more information about it on-line either. Does anyone here know any information about this treatment. My Neuro has had me on a CellCept since 2010 hoping to reduce my progression, which it hasn't as I have dozens of new lesions since 2011.
393685 tn?1425812522 OK - now the ACTUAL reason why Major and Time Caps were told to cease pro­duc­tion was due to them establishing themselves AFTER the 1962 “Drug Effi­cacy Amend­ment”, also called the Kefau­ver Harris Amend­ment proclaimed by the FDA. Being them as a NEW company, that is a dif­fe­rent issue than RLC and Forest whom have been producing desiccated thyroid hormone medication WAY before that Amendment. WHEW... I'm really tired. This was hard work today...
462771 tn?1358355843 My neuro calls and tells me that there are new lesions in the C-Spine (2, if I remember correctly) as well as a "re-activated" lesion that I had in C-3/4, which is the first lesion that I've ever had. The brain MRI came back "normal" even though I've had ON symptoms for about a month now - go figure. One thing that I don't understand is that he said "We're seeing new lesions in the spine, which we _never_ like to see" which I don't really get.
Avatar f tn As you may know, I was diagnosed with MS in April and have been on Rebif. I have had 2 relapses while on it. The first one was just a week of muscle spasms. I am currently in the 2nd one now and it has been active since 8/11/10. I have 3 days of I.V Solumedrol the 1st of sept and have felt no relief. With this one I have been having some new things going on that do not seem to fit with MS, at least not anything I can find. So this is what I'm hoping you can help me with.
1831849 tn?1383228392 The Peripheral and Central Nervous System Drugs Advisory Committee has recommended that the FDA approve alemtuzumab for the treatment of MS. As with any of our favorite concoctions there are serious risks, but the reduction in relapse rate seems to outweigh them. http://www.medpagetoday.com/Neurology/MultipleSclerosis/42899?
1831849 tn?1383228392 First is some good news for Avonex and Rebif users. It looks like Biogen-Idec is going to be seeking marketing approval for monthly dosing later this year. http://www.medpagetoday.com/Neurology/MultipleSclerosis/36993?utm_source=share&utm_medium=mobile&utm_campaign=medpage%2Biphone%20app Second is kind of a double edged sword. The FDA has approved over the counter sale of Oxytrol, a drug aimed at overactive bladder. They have approved it for sale to women bu not men.
Avatar f tn org The glaucoma drops Xalatan, Lumigan and Travitan Z grown eyelashes in about 70% of the people that use them. The FDA has just approved a formulation of lumigan called Latisse for use to grow eyelashes.