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Ramelteon in fda

Common Questions and Answers about Ramelteon in fda

rozerem

Avatar f tn Just go read all the comments of people that have taken the drug. That is all I'm going to say. It is not the fine print but the life print that matters to me.
985832 tn?1249126599 Ramelteon is the name for it in Canada and it is available.
Avatar f tn These drugs are believed to possess similar abuse potentials. Ramelteon (Rozerem), works differently in the body to treat insomnia. It is not considered to be a controlled substance. Zolpidem (Ambien) and eszopiclone (Lunesta) have been shown to reduce the time until sleep occurs and increase total sleep time. The sleep induced by them resembles natural sleep. Ramelteon (Rozerem) has shown to reduce the time until sleep occurs.
Avatar n tn Specifically, the delayed sleep phase syndrome. He prescribed Ramelteon to help her fall asleep at night. So far, the sleeping pill seems to work but in a subtle way. If she does not prep herself for sleep, sleep will not come. It has gotten so bad that she cannot remember the last time she slept and felt rested. There is a bit more to it then just a sleeping problem. I am not sure if this is related to it but she has laps of time where she can't remember specifically what she did.
Avatar n tn In human trials the assays are used in parallel with existing assays on large cohorts of non-medical (i.e. those in for testing) patients and results sent to the approvals agency and the manufacturer.agency. The knowledge that the vast majority of seroconversions occur within 3 months has been gained from clinical experience and limited studies on those presenting with ARS.
Avatar f tn Fda, getting movin! I have already written to my senators congressional rep , people will decompensate and probably die while we are waiting for sofo/ledip/sime.
390388 tn?1279636213 GLAD TO HEAR IT. This link can get you there. Scroll down to "Get Updates" (on the right hand side) of the main site of the FDA. There they have all the different "recalls" in which you can pick from on what updates you want. I get them via email. I don't know if you would have to check on any legal issues or not for your site. I'm sure they would be pleased though to know you are interested in getting their word out though. http://service.govdelivery.
366811 tn?1217422672 You may be aware that an extensive drug database is now online at Medhelp. You get to it simply by typing the name of the drug in the search box. Among the results, you'll see articles and information about the drug. Medhelp, however, thinks that might not be enough, because so many people continue to ask on the forums for info already in the database.
572651 tn?1530999357 The Division of Bioresearch Monitoring has developed training modules in FDA‑regulated device clinical research practices, which are available on the FDA website. The modules are for persons involved in FDA-regulated device clinical research activities. These modules are located at the following website address: http://www.fda.gov/Training/CDRHLearn/ucm162015.htm. If you have any questions, please contact Anne T. Hawthorn at (301) 796-6561 or Anne.***@****.
Avatar m tn This is an excerpt from that thread, which explains perfectly why WE stick to the 3 month official guideline here on this forum. No matter how strong new data may be, the manufacturer of a test may not legally claim a new standard until and unless they conduct their OWN research and submit the results to FDA -- an expensive process, so it rarely happens. (Same thing when drugs are found to work for medical conditions or in doses which were not initially approved by FDA.
1831849 tn?1383228392 The paperwork on Lemtrada for USA was being resubmitted, but the FDA had problems with the manner in which this study was crafted, and also had issues with the high rates of thyroid dysfunction in the test cohort, as well as some immune thrombocytopenia. They may drag this out, waiting more big numbers from use around the world before they approve it.
Avatar m tn not at all.it is wide accepted US fda is corrupted to the bone by testimony of people who was in the fda commissions (when not corrupted receiving tips for family members and sons life probability.........) the worst system in the world to look at!
29837 tn?1414534648 s our responsibility to help our friends who have very seriously advanced disease by calling whoever they ask us to call in the fda or drug companies. We could be the ones who are in the same situation soon also. I remember when when people were dropping so quickly from aids what an uproar occured in the infected community, and how politically motivated they became and how much pressure was put on the government to act. They got results finally from their actions.
Avatar m tn Pharmaceutical recalls were up a whopping 400 percent last year you can always toss a tainted toy in the trash, it's pretty hard to ditch a defective drug you've already swallowed. Last year, 1,742 meds were recalled up from 426 in 2008, according to trade publication Gold Sheet, which analyzed FDA data. Of course,The Pharm. Co. is quick to point out that the bulk of those recalls -- more than 1,000 -- came from a single drug repackager, Advantage Dose, which is now out of business.
Avatar m tn the FDA is still reeling from the thalidomide debacle in the 50's. But the science should be better now, do not always understand why it still takes so long - except that companies often fudge their numbers on side effects, etc.
438514 tn?1305734140 That's pretty standard of the FDA, they do this all the time (in other words, it's not earth shattering). Law requires any claims at cures (or more precisely 'treatment') be backed up by clinical trials, FDA clinical trials to be precise. That is why nobody can say any drug, supplement, etc, is a treatment or cure without first completing a multi-million dollar FDA clinical trial that will last for 10 to 20 years.
Avatar m tn m a oversea student in Australia from Taiwan. recently Im very stupid to had sex with two different incall girl(csw) in the city, which is over 90days from first sex and over 7 weeks from the last sex. After last sex I read information about HIV it makes me very nervous and scare think I infect HIV then I bought a lots home test kit online(most of them are ICARE HIV1&2 RAPID SCREEN TESTER, and few BLUECROSS ONE STEP RAPID TEST) some still on shipping don't know what brand.
603015 tn?1329862973 In Canada Rozerem is called Ramelteon. That is probably the scientific name. I believe according to one post I saw melatonin is not available in Canada anymore because it is unsafe. Rozerem however, is an FDA approved medication. I was informed by my psychopharmocologist that Rozerem is completely non addictive and works differently from all other known sleep aides though you could look at the medication website and ask your own psychiatrist to confirm.
Avatar m tn Replicor is a Candian company and to my knowledge FDA has nothing to do with it. Canada Health is equivalent to FDA in the US. Also I feel like there is no exposure to Replicor just because it is a private company. This is my three cents on this topic.
1301089 tn?1290666571 Accordingly, FDA expects to refrain from initiating enforcement action until after a time period established in the final guidance. FDA is interested in comments on the appropriate time period for enforcement after the issuance of final guidance. FDA anticipates issuing final guidance in December 2010. Vending machine operators, meanwhile, are worried about whether their small businesses will survive this single federal regulation that was sandwiched into the massive health care bill.
Avatar f tn It is more recognized in other contries. Because it is an application of the Yag laser, the FDA ruled that IT DID NOT REQUIRE FDA APPROVAL, so the statement that it is not FDA-approved is not really correct. Because the mainstream practice of medicine for whatever reason WILL NOT study it, it is true that there are no peer-reviewed studies. There may be no studies because there is no drug company or equipment maker to benefit, so no motivation for the studies.
163305 tn?1333668571 NEW YORK (AP) — The potential scope of the meningitis outbreak that has killed at least five people widened dramatically Thursday as health officials warned that hundreds, perhaps thousands, of patients who got steroid back injections in 23 states could be at risk. Clinics and medical centers rushed to contact patients who may have received the apparently fungus-contaminated shots.
Avatar f tn Most people on this forum are working on the cure with FDA approved or in trial meds. It looks like hep technologies has a contact page, they may be able to tell you if you do not get a response here. Good luck. http://www.heptech.com/contact.
Avatar m tn your result in days is reassuring, and not likely to change. FDA=Food & Drug Administration (of USA) and CDC= Centers for Disease Control and Prevention.
Avatar n tn When healed up, docs starting injecting Avastin into his eyes, one injection in each eye. I have since discovered that this is not FDA approved for injection into the eyes, but only FDA approved for colorectal chemopatients. Dad has had lazer treatment which left him with severe damage in his eyes years, ago. I know about the FDA approved injection into the eyes called Macugen (I think that is the spelling), but it costs $2,000 or more for one injection.