Actiq fda approval

Common Questions and Answers about Actiq fda approval

actiq

962117 tn?1416358616 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.
655467 tn?1304959950 I do not care how much or what opiates one has to take,but Actiq is something that should have NEVER been approved by the FDA. You want to wind up like meth addict? Please Never touch that drug!!! Storm This discussion is related to <a href='/posts/show/1017971'>fentanyln patch</a>.
Avatar f tn I was offered to apply for the study, but I am going to wait for the approval from the FDA.
Avatar f tn 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.
789572 tn?1334424879 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.
Avatar m tn 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?
Avatar n tn s amazing the advance that are being made in the medical industry. The FDA has been notoriously slow in approval in their approval of some medications/treatments where in other instance they seem to rush them through. It makes little sense to me. Thank you for your question. I've learned a lot and I hope that other members have also. We'll look forward to hearing from you again.
29837 tn?1414534648 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.
Avatar m tn I was put on fentanyl patches round the clock and Actiq for breakthrough pain. At the time my insurance company covered it. Shortly before an unrelated insurance company change I received notification that the medication would not be covered anymore. We changed companies and the new company did not cover it either. I am in the appeal process at this time. I just received a denial for the first appeal.
Avatar f tn 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!
107366 tn?1305680375 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.
29837 tn?1414534648 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.
585414 tn?1288941302 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...
550739 tn?1224163372 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!
483733 tn?1326798446 I've been following the tweets from the FDA hearing today that my own rheumatologist, Dr. Murray Urowitz, spoke at. Here are the results: LupusOrg Lupus Foundation Voting question: has #benlysta demonstrated substantive evidence of efficacy.
Avatar f tn 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.
Avatar n tn 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.