forteo 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.

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.

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?

I have been on Forteo daily injections for 1 year and I have experienced considerable joint pains which did not exist prior to treatment. My left hip and knee, my right knee and my hands have been getting worse each month. Has anyone else experienced similar reactions?

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!

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.

My doctor told me that I have Osteoporosis and wants me to try Forteo an injection for two years. Has anyone tried this drug and what were your side effects, if any. I don't want to make my stomach problems worse than there already are.

Hi-- When you say Medicare, I assume it is Medicare Part D, administered by an insurance company like Blue Cross, etc? If so, you might be in for sticker shock. I had a similar experience w/ Forteo, via Part D, they wanted $5K for 3 months. I went directly to Lilly, and qualified for pro bono meds for 2 years, the limit of tx on Forteo. My understanding is patients with cirrhosis get priority. Other Gilead experienced persons, and there are a few here, can tell you more.

I have severe osteoporosis and am trying to take Forteo. I started out with half dose and have worked up to a full dose. The full dose 2 days in a row was disabling. My doctor suggested every other day. So I let the previous trial work its way out of my system for 5 days and tried another full dose. This is three days after the dose and I am weaker each day. I move in slow motion. My doctor is puzzled. Anyone had a similar experience?

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!

Just was informed that I have osteoporosis. My doctor wants me to use Forteo, an injection that you use for two years.

Forteo fda approval

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