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Last updated on April 18, 2014 at 1:21 EDT

Latest PREZISTA Stories

2014-04-01 08:28:25

RARITAN, N.J., April 1, 2014 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen), today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for a once-daily fixed-dose antiretroviral combination tablet containing darunavir, a protease inhibitor developed by Janssen R&D Ireland and marketed as PREZISTA(®) in the U.S., with cobicistat, an investigational pharmacokinetic enhancer or boosting agent, developed...

2013-05-30 12:27:02

Most Survey Participants Would Recommend Joining a Study to Others TITUSVILLE, N.J., May 30, 2013 /PRNewswire/ -- A survey of a segment of clinical trial participants from the GRACE (Gender, Race And Clinical Experience) trial, the largest-ever study of treatment-experienced adult women with HIV to examine gender differences in response to HIV therapy, found that after taking part in the study, 96 percent of survey responders would recommend participation in a clinical trial to...

2013-01-16 04:21:24

CORK, Ireland, January 16, 2013 /PRNewswire/ -- In the news release, "European Commission Approves PREZISTA® (darunavir) 800 mg Tablet Once a Day Reducing the Number of Pills Taken by People Living With HIV" issued on 16 Jan 2013 08:00 GMT, by Janssen R&D Ireland over PR Newswire, please be advised that the first note following paragraph three has been corrected to read "i. ART-experienced adults with no darunavir resistance associated mutations (DRV-RAMs) and who have plasma HIV-1...

2013-01-16 04:21:12

CORK, Ireland, January 16, 2013 /PRNewswire/ -- Janssen R&D Ireland announced today that the European Commission (EC) has approved a new PREZISTA(R) (darunavir) 800mg tablet allowing people living with HIV to take one darunavir tablet once a day. Darunavir is indicated in combination with other antiretrovirals for the treatment of human immunodeficiency virus (HIV-1) infection in treatment-experienced and treatment-naive patients with no darunavir resistance-associated...

2012-11-09 16:24:26

TITUSVILLE, N.J., Nov. 9, 2012 /PRNewswire/ -- Janssen Therapeutics, Division of Janssen Products, LP, announced today the U.S. Food and Drug Administration (FDA) has approved a new 800mg tablet of PREZISTA(®) (darunavir) for once daily oral administration for the treatment of human immunodeficiency virus (HIV-1) in treatment-naive and treatment-experienced adult patients with no darunavir resistance-associated mutations. PREZISTA(®) is always taken with and at the same time as...

2012-05-29 02:27:29

TITUSVILLE, N.J., May 29, 2012 /PRNewswire/ -- Janssen Therapeutics, Division of Janssen Products, LP, announced today the U.S. Food and Drug Administration (FDA) has issued a Complete Response letter for a Supplemental New Drug Application (sNDA) for an 800mg tablet of PREZISTA® (darunavir). PREZISTA is approved for once-daily oral administration of 800mg -- two 400mg tablets -- for the treatment of human immunodeficiency virus (HIV-1) in treatment-naive and treatment-experienced adult...

2012-04-24 02:31:01

TITUSVILLE, N.J., April 24, 2012 /PRNewswire/ -- It lies within the compact folded rectangle that accompanies prescription medicines. In black and white on paper, it follows prescription medicine advertisements in magazines and newspapers. Known as patient information, it is frequently part of the U.S. Food and Drug Administration (FDA) approved labeling for prescription medicines. To view the multimedia assets associated with this release, please click:...

2011-10-21 08:21:00

TITUSVILLE, N.J., Oct. 21, 2011 /PRNewswire/ -- Janssen Therapeutics, Division of Janssen Products, LP, announced today that the U.S. Food and Drug Administration (FDA) has approved a label update for PREZISTA® (darunavir) tablets to include 192-week data from the ARTEMIS study. ARTEMIS evaluated the efficacy and safety of PREZISTA with ritonavir (r) vs. lopinavir/r in combination with other antiretrovirals (ARVs) for the treatment of human immunodeficiency virus (HIV-1)...

2011-06-28 07:30:00

CORK, Ireland, June 28, 2011 /PRNewswire/ -- Tibotec Pharmaceuticals today announced that it has entered into a license agreement with Gilead Sciences, Inc., for the development and commercialization of a new once-daily single tablet fixed-dose antiretroviral combination product containing Tibotec's protease inhibitor PREZISTA® (darunavir) and Gilead's cobicistat, an investigational pharmacoenhancing or "boosting" agent. PREZISTA, co-administered with ritonavir...

2010-12-13 17:37:00

TITUSVILLE, N.J., Dec. 13, 2010 /PRNewswire/ -- Tibotec Therapeutics, a division of Centocor Ortho Biotech Products, L.P., announced today that the U.S. Food and Drug Administration (FDA) has approved a revision to the dosing recommendation to include once-daily dosing of PREZISTA® (darunavir) tablets in combination with ritonavir for the treatment of human immunodeficiency virus (HIV-1) in treatment-experienced adult patients with no darunavir resistance-associated...