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Fda rosiglitazone july 2010

Common Questions and Answers about Fda rosiglitazone july 2010

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Avatar m tn Rosiglitazone, an old diabetes drug is active on hbsag lowering and synergistic with nucs and interferon.these are the drugs to study not stupid nucs that acts on hbvdna only making mutations. on the contrary studies on these cheap and generic durgs are not funded by drug makers, on the contrary we see stupid doctors without trials or studies saying now that these drugs can make liver damage while it is the opposite.
29837 tn?1414534648 They are going to use a “rolling NDA” (New Drug Application) submission to the FDA starting the quarter of July of this year. Another very interesting thing he told me is that they are doing a small Phase 2 study combining Telaprevir with VX-222, without the awful Interferon and Ribavirin. Keep your fingers crossed on that one... So, I will report as he reports to me.
Avatar f tn In addition she maintained 30 minutes of aerobic exercise 5-7 days a week most weeks since diagnosis. In July, 2010, despite compliance to treatment, she was not improving as we expected and we began to be concerned about her ability to start school and extracurricular activities. She started midodrine in July, 2010 beginning with 2.5 mg dose three times a day progressing to 7.5 mg three times a day until early August.
1594263 tn?1297221575 Should be ready and FDA approved in June or July.....you will be fine until then. No drinking and no smoking. Eat a well balanced fat free diet. Don't despair....we're with you !
Avatar m tn did they give you MRI metal, Gadolinium metal? fda gov blackbox warning? no mention of metal? see mri side effects, willis law firm, ignore him, he won't take case unless NSF diagnosis by skin doc, but you can have retained metal that dechelates or is retained if told to take iron, zinc , copper, etc, read rsna org, auntminnie com and fiercebiotech com sites, see fda gov and nyas org, free registration, Fourth Annual NSF conference, e briefing 13 Sept 2010.
Avatar f tn I know that it still hasnt been approved byy the FDA but I read that if added to the combo therapy, it can make the chances go up for a SVR....
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...
Avatar n tn the opportunity to submit comments to FDA hearing FDA-2010-N-0107 on expanding early-access to DAA drugs is about to close. The hearing docket now includes a full transcript of the hearing held on April 30 and a number of interesting comments by drug manufacturers and advocacy groups. However only a couple of patient comments have been submitted.
29837 tn?1414534648 s the difference. A Standard Approval (by the FDA) means that the maximum amount of time the FDA can take in approving a new drug is 10 months. A Priority Approval means the FDA has to either approve or not approve a new drug within a maximum amount of time no greater than 6 months. Vertex is submitting a Rolling NDA for Telaprevir. This means that if they file for it with the FDA this month, it can be approved by the end of this year and we could initially get the drug in January, 2011.
179856 tn?1333547362 Vertex was granted Fast Track designation by the FDA for telaprevir in 2005. In mid-2010, as part of the Fast Track designation, Vertex began to submit completed sections of the NDA for review by the FDA on a rolling basis rather than wait until every section of the application was complete" I hope this is the start of something grand! Someone had posted the timeline for FDA approval but I don't remember it. Hope it is soon....
5558609 tn?1369861434 It all started in July 2010, we had gone on vacation and I gained about 10lbs. I didn't think much of it at first since I have always had a struggle to evacuate my bowels while I am traveling. I started to have the heaviest periods to the point that I had to wear adult diapers! I was 31 years old and had always had regular menstrual cycles and this scared me. Every month for the next 6 months my weight steadily increased 10 more pounds.
29837 tn?1414534648 As a footnote, I've tried the IND application through my doctor, but Vertex refused. I would bet my liver that it was because of the potential lawsuit that could arise if the victim who was given this drug (Telaprivir) happened to die before the FDA approved it. Vertex, along with other pharmaceutical companies are reluctant to release new drugs before FDA approval. I cold be wrong, but logic dictates that this is the protocol. At any rate, below is the answer from the FDA to me...
1421938 tn?1318603558 You're right Lisa, always wait at least 2-3 cycles, I was also told to wait that extended period of time. Like you said, giving the uterus time to rest, and heal, and also, as you stated and my ob/gyn stated giving the lining time to build back up, is also essential. My ob/gyn said without the adequate building up of the lining, can prevail into a miscarriage again. I am also getting up there in age. I am 39 40 next June.
1379684 tn?1279062790 i stopped my period on july 5 , 2010 and had sex 7 day after my period which was on july 12 , 2010 and on july 13 , 2010 i started to bleed and today which is july 20 ,2010 i have stopped bleeding could i be pregnant or what
Avatar n tn Actually July 11, 2010 about 1 hour I felt it not July 14, 2010.
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.