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Levocetirizine nda

Common Questions and Answers about Levocetirizine nda

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Avatar n tn Xyzal) for my allergies, I skipped it this morning since I was going in for a blood test and urine test, but I did take a dose yesterday. Will Levocetirizine affect the outcome of the test in any way? Thanks in advance!
Avatar f tn Hydoxyzine worked wonders for me (once I got a high enough dose). I take 25 - 50 mg. every 6 hours. I had a bad rash all over my body except my face and buttocks and it stopped the itching and is clearing the rash. I wish they would have started it in Dec,. but it seems with these side effects we are all re-inventing the wheel. The docs seem clueless.
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 n tn For burning throat, gargle with salt water immediately and keep doing it. Take Montelukast+levocetirizine for 10 days one daily(0-0-1) preferably night. take multivitamins and gargle with Tantum before food, betadine(1:5) and hydrogen peroxide(1:10) after food for three days. Take dichlo for pain relieving for 2 days(1-0-1). If symptoms persist, rush to the ENT specialist.
Avatar m tn I'm allergic and I know it! I've been allergic ever since I was a little boy and I've learned to live with that. My problem is that during the last couple of years, I seem to get more and more sensitive to the allergens that trigger my reactions, as well as more prone to have shortness of breath as a primary reaction! This year, although spring hadn't affected me so far, I happened to catch a cold (whether it was the flu, a cold or bacterial infection I don't know!
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 m tn Runnning nose and watery eyes and i have taken levocetirizine dihydrochloride 5mg... it seems better but my head has become heavy after taking the medicine.. please advice and can i take steam ? what are the precautions that needs to be taken ?
Avatar n tn These include levocetirizine, loratidine etc. this can be combined with nasal decongestants (combination are available) and should be taken against prescription. Take care and regards.
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.
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 n tn Hi I have had severe Hives for 2 mos. This is the worse outbreak I've ever had, and my last case of Hives was 9 yrs ago. I was in the ER 2x this past month, put on IV steroids, antihistamines & Ranitidine. I had extensive blood work done for a multitude of alleries- all negative, Lupus, Lympoma, Lymes disease, CAT scan, all negative. I've done 2 rounds of Presnisone (which helped greatly), but 2 days after the last Prednisone pill- boom the hives came back bad.
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