pegasys fda approval

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.

Wait until they have perfected the oral med 2-3 years, will have few side effects.

(PDUFA dates are deadlines for the FDA to approve new drugs. The FDA is normally given 10 months to review new drugs. If a drug is selected for priority review then 6 months is allotted. These times begin from the date a NDA is submitted). Additionally, Vertex today announced the completion of a New Drug Submission (NDS) to the Therapeutic Product Directorate (TPD) of Health Canada seeking approval for telaprevir in Canada.

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.

Sorry but nothing has been approved but just submitted to the FDA for approval. October would be the earlist for just approval. When they would hit the market nobody knows for sure but I would guess soon after.

I read that the fda approved dosage is 1.5 mcg per kg. Is that the ideal dosage or is it higher? I figure at my weight of 85 kg I was getting 1.76 mcg per kg. Now I am being dose reduced to a little over 1.05 mcg per kg (the guideline for adverse event neutropenia). There's really nothing I can do, just obsessing about the reduction. I am going to have two injections at that level before I see the doc again and hopefully go back to full dose. These will be week 8 and week 9 injections.

My first pegasys and ribaviron was ordered through a local pharmacy at $606 copay for the pegasys and $50 for the ribaviron. I looked on the blue cross blue shield web site and found I could have them sent to me through their preferred pharmacy for a $69 copay for pegasys and no copay for ribaviron. Hope my experience saves you a lot of money!! There's a number to call to get the fax number to give your doctor to send in the prescriptions. Welcome and good luck!

53am BST ZURICH, June 26 (Reuters) - Roche Holding AG said on Thursday it had received European Union approval for a shortened treatment course for Pegasys in combination with Copegus for certain hepatitis C patients. The 16-week course will be available for patients with genotype 2 or 3 strains of chronic hepatitis C who have low virus levels before starting treatment and show rapid virological response, the Basel-based drug maker said.

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

U.S. FDA and Health Canada Grant Priority Reviews for Telaprevir for the Treatment of Hepatitis C -Six-month review date of May 23, 2011 set by FDA- CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for telaprevir and granted the company's request for six-month Priority Review.

I am using Pegasys 180mug q/wk as an off label use to treat Polycythemia Vera and it works well.I will have to take this med the rest of my life. I am aware of the short term side effects, but what about long term side effects? What can I expect years from now?

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.

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?

t give me a definite time line for the compassionate release, he did say that telepravir being in Phase III, they are seeking approval by the FDA in the second half of 2010, and making it available through prescription instead of the current clinical trials. Interestingly, he added a comment that we could hopefully expedite the "compassionate" use approval by the FDA if we write them an email stating the urgency for those who need this NOW.

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.

The only important piece of information here is that both drugs seemed to get a favorable review and are likely to get FDA approval within 2 months.

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!

Pegasys fda approval

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