exenatide once weekly fda approval

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

That's the new oral anticoagulant that's been making its way to FDA approval, which was finally given today. No INR monitoring, no food interactions. But cost might be $10/day rather than 10 cents. https://us2.ixquick.com/do/metasearch.pl?

I am sorry. I am wrong about FDA approval for albuferon. It is still pending. Focus groups have not found that cutting the injections in half matter to most patients. In fact it is believed that there would be more people forgetting to take the injection when there is a longer time between shots.

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.

I can tell you that there is currently nothing which is FDA approved for the treatment of Dry Age Related Macular Degneration (Dry AMD). There are lots of studies and trials in the works; seeking FDA approval. I don't know of any which are CE marked for Europe. The current recommendation is weekly amsler grid which can be downloaded free online.

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.

They make you jump through hoops, they may require you to attempt other treatments, but if you qualify (and by that, I mean under generally accepted medical guidelines, and with FDA approval), ultimately, you will prevail. This only got easier under HCR. Do you recall any new AIDS drugs getting FDA approval, but being denied, en masse, by insurance companies? It just does not happen. And for the record, there is PLENTY wrong with insurance companies denying coverage.

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.

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.

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!

That's great news. You heard before I did. I'm on the clinical trial. I wonder if they will discontinue the trial once it's approved. Or will they continue the trials until the end? I know TAF is approved to treat HIV now so Hep B was the next step.

Drug manufacturers are required to file IND with FDA. Once accepted, the IND allows the sponsor to ship the drug in interstate commerce for research purposes only. The responsibility for the sponsor determines that adequate and well-controlled studies showing the drug is safe and effective have been carried out, that information, coupled with information on the manufacturing procedures and controls used in producing the drug, is submitted to FDA in the form of NDA.

Monday, July 20, 2009 FDA Approves Stevia Update note: This breaking news article has been updated from its original version to clarify the nature of the FDA's GRAS "approval" for stevia. In the original breaking news, we reported that the FDA had granted GRAS approval to stevia. Technically, the FDA has only issued letters of "no objection" regarding companies' self-affirmation of GRAS approval for stevia.

The FDA has given fast track approval for Telaprevir & Boceprevir which means these drugs should be approved and ready for market sometime this summer. We still don't know what protocol the drug companies will use to approve the use of the protease inhibitors as in genotype 1 only, relapsers, null responders. After approval, the new drugs will have to be included in the drug formulary that insurance companies use for drugs covered under their plan. That may take a little time as well.

I believe that the FDA wouldn't give approval but it was overturned by a judge. It is not known as a "quitting aid" but as another smoke product. I did a little research and saw some offered nicotine and some didn't. Regardless, e-cigs have other ingredients. I would love to know how long a "kit" lasts? What is the daily, weekly, monthly cost? At some point, people will have to acknowledge that smoking is bad, harmful and could kill.

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 know Vertex has hired sales reps in anticipation of it being approved. FDA has 45 days starting 11/23 to decide on fast track approval 6mo or reg approval 10 months. Not sure if that's business days or calendar days. But should be coming up. The study results as so good it's hard to imagine delaying approval to market as that one guy said. I will be sure to ask my doc about how fast it will be available to order once approved.

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.

While the cost for the substance itself will be drastically lower, once mass production can be used, a weekly infusion in a hospital or clinic is in itself as a procedure very expensive and would shy away insurance carriers or self payers. For that reason, Replicor rightfully treis to improve on the drug towards a subcutaneous application that can be given to the patient for use at home.

Here is s link to the FDA approval -- select 05/2011 and click the submit. I just did it and the list only goes throu 5/6. Keep checking it -- I know I will, all day. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Reports.

Exenatide once weekly fda approval

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