Risperdal consta fda approval

Common Questions and Answers about Risperdal consta fda approval

risperdal

Avatar n tn How does one switch from Risperdal Consta (50mg Q2wks) to Invega Sustenna??
Avatar n tn OK I JUST STARTED TO TAKE RISPERDAL CONSTA 37.
Avatar m tn I took Risperdal Consta and Lithium for 7 months while being in the hospital. When I got out of the hospital, boy was I sorry! My cognitive abilities were down about 70%. I also had sleeping problems and chronic fatigue. When I read a book, I had no memory retention of what I read. If you value your son's life, take him off all the drugs, drugs are poison, and take him to a homeopathic doctor.
Avatar n tn Without knowing the actual dosage given, it is impossible to give you an exacting time frame. If he was given the Risperdal Consta injection, the effects would persist beyond one month. This would seem highly unlikely. In my opinion, this toxidrome will resolve without incident in a week or less. If there are no signs of improvement soon, definitely head back for the ER and demand some answers. Keep an eye on temperature and pulse, as those are two good indicators for NMS.
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.
Avatar f tn he also has intermittent explosive disorder. The doctor prescribed Risperdal. I've just read horrible things about it. What have other parents experienced with this drug? Is there a better alternative? He is already on mineral supplements, vitamin supplements, and fish oils.. Thank you for any "experience information.
Avatar m tn Unless I am mistaken you have been off of the Risperdal for a month or so now. The effects of it should be gone by now. What do you mean by feeling normal? Some people say normal and they mean happy. If you are wondering how long it will take you to feel happy again- that is a complicated question but I can try to answer it by asking some questions. What do you mean by normal Clifford?
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?
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 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.
559509 tn?1216180446 Does anyone out there take Risperdal for Bipolar Disorder? I don't see hardly any mention of it around this site. Does it make you gain weight like Depakote? Does anyone out there take it for Bipolar Disorder Type 2? Any opinions or thoughts? I am currently on Lamictal and Welbutrin. I show mixed tendencies ( is that type 1 ),and my Dr gave me Risperdal for what appeard to be a manic state( I was off all meds at the time except Welbutrin which may have excaserbated my mania).
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.
Avatar n tn I must disagree with the other poster. Risperdal was approved by the FDA for use in children on the spectrum in 2006 to treat *repeated* bouts of aggression and irritability as are other anti-psychotics. My son was diagnosed with Asperger's when he was 3 and has been taking Risperidone (Risperdal) for 4 years in varying dosages. Without it he could not have attended mainstream schooling as his aggressive outbursts were a danger to himself, other children and adults.
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!