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Trilipix nda

Common Questions and Answers about Trilipix nda

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Avatar n tn 1 month later he was not saticfied with the drop in cholestoral so he put me on a fairley new drug called Trilipix. I take 10mg of lisinopril for high blood pressure, 10 mg of crestor, and 145mg of trilipix. After being put on the trilipix I started felling tired and having stomache problems (constipated and cramping). I went back to have my a1c check last week and it was 8.0.
Avatar f tn Thank you for answering my question. Yes I take trilipix and lipitor.
Avatar m tn Food and Drug Administration (FDA) has granted priority review to the company’s New Drug Application (NDA) for sofosbuvir, a once-daily oral nucleotide analogue inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. The FDA grants priority review status to drug candidates that may offer major advances in treatment over existing options.
29837 tn?1414534648 Spoke to my contact at Vertex today. They are still compiling all data for the NDA (New Drug Application) of Telaprivir. This means they are hopeful all data will be submitted to the FDA before the end of the year. Unfortunately, this means more waiting. However, once they do present the final data, there will be a Fast-Track priority for the FDA to approve or not approve the drug. Once all the data is in the hands of the FDA scrutinizers, they have to approve or disapprove within 6 months.
29837 tn?1414534648 Merck has started to start applying; "We are excited by the results of these pivotal studies," said Dr. Peter S. Kim, Ph.D., president, Merck Research Laboratories. "In these studies, boceprevir substantially increased success rates compared to standard therapy, both for patients who received 48 weeks of treatment and for patients treated with the response-guided therapy approach, many of whom were able to be treated for 28 to 36 weeks," he added.
Avatar m tn Gilead filed the NDA (new drug application) for ledipasvir/sofosbuvir (LDV/SOF) February 10, 2014 and the FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of October 10, 2014. The FDA has also assigned LDV/SOF a Breakthrough Therapy designation. The FDA grants Breakthrough Therapy designation and priority review status to investigational medicines that may offer major advances in treatment over existing options.
Avatar m tn I have been on Lisinopril (bp) for 5 years and Trilipix and Simvastatin (cholesterol) for the last 3-4 years.
Avatar m tn This meeting is to discuss the treatments for hepatitis C that Gilead has submitted to the FDA for approval in April of this year. Gilead filed the NDA (New Drug Application) for sofosbuvir on April 8, 2013.
Avatar f tn Before getting pregnant, my HBeAg was (-) and NDA viral load was 10 log 3. Now after 3 months, my HbeAg turns (+) and NDA viral load increases to 10 log 6, and my ALT is 43 (normal upper range is <40). My ALT was well below the uppper range before. My doctor prescribed Zefffix to be taken 1st week of month 5 prenancy but I am reluctant to take as I dont know what it will do to my little one. Any advice please!! I am so confused now. Thank you all!!
Avatar n tn Here are the meds I am own - Questran - 1 packet for irritable bowl, Prozac for OCD, Allergy Injections, Methyldopa for blood pressure, and Trilipix for Triglycerides (nearly 1000), and Vitamin D. I am only 30!! I am overwieght but work hard to get rid of it with little or no results. They even checked me for Cushings. My TSH is low at 0.3 and I have a Goiter but no known thyroid problem. I have acne. Anyone know what could be causing my heartburn to be so severe?
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 f tn Food and Drug Administration (FDA) has granted priority review to the company’s New Drug Application (NDA) for sofosbuvir, a once-daily oral nucleotide analogue inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. The FDA grants priority review status to drug candidates that may offer major advances in treatment over existing options.
315318 tn?1353251800 Recently , I was prescribed a fenofibrate (Trilipix 135 mg) along with Crestor. My cardio wanted this for helping in getting my triglycerides down. I have not had a lipid profile done since starting on this med two months ago. However, since being a diabetic , I check my blood glucose (BG) many times during the day and what I am noticing is a clear trend in the BG numbers going lower at least over the last month or so.
Avatar f tn 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. After comprehensive review by the FDA, the NDA is either approved or not approved; upon approval, the drug may be marketed.
Avatar m tn Antiviral Drugs Advisory Commitee Meeting Announcement Agenda The committee will discuss new drug application (NDA) 204671, sofosbuvir (an NS5B polymerase inhibitor), manufactured by Gilead Sciences, Inc., with a proposed indication for the treatment of chronic hepatitis C infection, in combination with other agents in adult patients with genotypes 1 to 6 and/or adult patients awaiting liver transplantation. http://www.fda.gov/AdvisoryCommittees/Calendar/ucm368560.
Avatar n tn Today I went for I walk and wen I come back I got the feeling I want it to go pee but wen I went part of my underwear was wet with a Lil bit of discharge and again after 4 min I got the same sensation and come back and I checked it and it was wet so I changed my underwear and put I pad and nda it's wet too and wen I clean up the toilet paper has like watery it's look transparent, I'm 38w+6days
Avatar m tn I agree. The benefits outweigh the few, (if any at all) side effects from taking the benzo's every day for over six years. I'm 26 now without insurance, and they are the cheapest of the meds I am on. Trilipix is 184USD, Crestor is 189USD, and even generic gabapentin is 154USD. Lexapro is about 140UDS. Generic Klonopin is about 10USD. Remeron is about the same. And Inderal is 4USD. This is all per month, and I need every one of them.
Avatar m tn twice a day, Amlodipine Bensylate 5mg. once a day, Trilipix 135mg. once a day and Ibuprofen 600mg. when needed. Pravastatin Sodium 40mg. once a day and Alprazolam 1mg. twice a day. I have been to my doctor and have told him about it and he just says, its anxiety. Does anyone know what might be causing this ?? I am tired of hearing that it is anxiety ! Please help !!!!!!!!!!!
Avatar m tn hi i tested oral swap and penis swap for hpv pcr nda test and all the types of hpv came not detecable.. does that mean im clear ?
2203249 tn?1338990446 Food and Drug Administration (FDA) has granted priority review to the company’s New Drug Application (NDA) for sofosbuvir, a once-daily oral nucleotide analogue inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. The FDA grants priority review status to drug candidates that may offer major advances in treatment over existing options.
Avatar m tn Food and Drug Administration (FDA) has granted priority review to the company’s New Drug Application (NDA) for sofosbuvir, a once-daily oral nucleotide analogue inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. The FDA grants priority review status to drug candidates that may offer major advances in treatment over existing options.