aliskiren nda

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.

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.

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.

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.

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.

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!!

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.

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.

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.

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.

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

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 ?

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.

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.

I will only comment of Gilead's strategy as I am not familiar with Abbvie's products and I know Gilead's HCV strategy of the next few years. Plus I have been in a Gilead trials for 45 weeks now. Others can comment on Abbvie products. As far as trial for Gilead trials...there are many different types of patients being treated and treatment can be different based on patient factors such as genotype, cirrhosis, treatment experience vs treatment naive etc.

Food and Drug Administration (“FDA”) has issued complete response letters regarding its New Drug Applications (“NDA”) for ULTRASE® MT and VIOKASE® in the treatment of exocrine pancreatic insufficiency (“EPI”). A complete response letter is issued by the FDA when the review of a file is completed and questions remain that preclude the approval of the NDA in its current form.

Gilead submits TAF NDA for hepatitis B (Jan. 12) http://seekingalpha.

----------------------------------------------------------------------------------------- On April 8, Gilead submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for sofosbuvir for the treatment of HCV infection. The data submitted in the NDA support the use of sofosbuvir and RBV as an all-oral therapy for patients with genotype 2 and 3 HCV infection. The Food and Drug Administration has set a target review date of Dec. 8.

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