neupogen fda approval

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.

It seems that your doc is on top of things and is watching it. If your doc decides he needs to re-evaluate your dosage, ask him/her about a shot of Neupogen instead of reducing your meds. Many people on TX have had their white blood cell count go too low and they have had to take an additional injection called Neupogen. Some docs do it that way instead of reducing the treatment meds. Be sure to ask about it to see what his/her opinion is on it.

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.

( i have had 8 injections) I saw Dr 3/6 and was told to stop all treatment until approval for Neupogen. I was due to take Pegaysis SQ on 3/6 and to Dc ribovarin also. I offered to get RX and fill it out of pocket or reduce dose and dr refused. I am upset and not sure how to proceed. Dr says interruption in TX should not affect Sustained effect. Tx will just be extended at the end. I just wanted to vent and get any pointers. Thank you for listening.

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?

Avastin is not approved by the FDA and the FDA took away approval from breast cancer. Insurance companies will not pay for it. In fact all studies have stopped. I'd like to know what other choices do I have? I'm scared, and I feel that soon I'll be at the end of the road. This discussion is related to <a href='/posts/show/377978'>caelyx treatment CA125</a>.

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!

Hoping to hear soon about fast track approval by FDA. Application was submitted by Vertex 11/24, and FDA has up to 45 days to respond on the request.

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.

t know a lot about this subject but here in UK my doc says that these drugs will need to get a separate European licence after they get FDA approval. He reckons this might take about a year after FDA approval. Then the UK national health service body NICE has to decide whether to pay for them or not and that's a big can of worms. But they pay for ifn and riba at the moment, so hard to see how they could refuse something more successful which can cut treatment times.

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...

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!

2 The doctor wants to lower pegasys dose and has not mentioned anything about Neupogen as an alternative. Taking another blood test in the am but uncertain about the lower dose of pegasys and the if it will actually work. Ribivarin is the co pilot if you were wondering. My third week is Friday.

How does a doctor get approval for the rescue drugs. I've been told they are not approved for use with hcv tx although they used all the time. If your numbers improve because of the rescue drugs, then there seems to be a problem proving to the insurance company that you still have neutropenia or anemia.

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.

Neupogen fda approval

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