Drugs and Diseases » NewDrugs http://www.druganddisease.com Up to date news on the latest drugs and diseases Thu, 29 Jul 2010 19:07:44 +0000 http://wordpress.org/?v=2.9.2 en hourly 1 Tibotec Pharmaceuticals Submits New Drug Application for Investigational Once-Daily HIV Treatment TMC278 to U.S. Food and Drug Administration http://www.druganddisease.com/tibotec-pharmaceuticals-submits-new-drug-application-for-investigational-once-daily-hiv-treatment-tmc278-to-u-s-food-and-drug-administration-2/ http://www.druganddisease.com/tibotec-pharmaceuticals-submits-new-drug-application-for-investigational-once-daily-hiv-treatment-tmc278-to-u-s-food-and-drug-administration-2/#comments Mon, 26 Jul 2010 14:07:24 +0000 admin http://www.druganddisease.com/tibotec-pharmaceuticals-submits-new-drug-application-for-investigational-once-daily-hiv-treatment-tmc278-to-u-s-food-and-drug-administration-2/ TITUSVILLE, N.J., July 26 /PRNewswire/ — Tibotec
Pharmaceuticals today announced the submission of a New Drug
Application (NDA) to the U.S. Food and Drug Administration (FDA)
for TMC278 (rilpivirine), an investigational non-nucleoside…


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]]> http://www.druganddisease.com/tibotec-pharmaceuticals-submits-new-drug-application-for-investigational-once-daily-hiv-treatment-tmc278-to-u-s-food-and-drug-administration-2/feed/ 0 Tibotec Pharmaceuticals Submits New Drug Application for Investigational Once-Daily HIV Treatment TMC278 to U.S. Food and Drug Administration http://www.druganddisease.com/tibotec-pharmaceuticals-submits-new-drug-application-for-investigational-once-daily-hiv-treatment-tmc278-to-u-s-food-and-drug-administration/ http://www.druganddisease.com/tibotec-pharmaceuticals-submits-new-drug-application-for-investigational-once-daily-hiv-treatment-tmc278-to-u-s-food-and-drug-administration/#comments Mon, 26 Jul 2010 14:07:24 +0000 admin http://www.druganddisease.com/tibotec-pharmaceuticals-submits-new-drug-application-for-investigational-once-daily-hiv-treatment-tmc278-to-u-s-food-and-drug-administration/ TITUSVILLE, N.J., July 26 /PRNewswire/ — Tibotec
Pharmaceuticals today announced the submission of a New Drug
Application (NDA) to the U.S. Food and Drug Administration (FDA)
for TMC278 (rilpivirine), an investigational non-nucleoside…


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]]> http://www.druganddisease.com/tibotec-pharmaceuticals-submits-new-drug-application-for-investigational-once-daily-hiv-treatment-tmc278-to-u-s-food-and-drug-administration/feed/ 0 FDA Approves Tribenzor, A New Three-In-One Combination Product for the Treatment of High Blood Pressure http://www.druganddisease.com/fda-approves-tribenzor-a-new-three-in-one-combination-product-for-the-treatment-of-high-blood-pressure/ http://www.druganddisease.com/fda-approves-tribenzor-a-new-three-in-one-combination-product-for-the-treatment-of-high-blood-pressure/#comments Mon, 26 Jul 2010 13:07:39 +0000 admin http://www.druganddisease.com/fda-approves-tribenzor-a-new-three-in-one-combination-product-for-the-treatment-of-high-blood-pressure/ PARSIPPANY, N.J., July 26 /PRNewswire/ — Daiichi Sankyo, Inc.
announced today that the U.S. Food and Drug Administration (FDA)
approved Tribenzor (olmesartan medoxomil, amlodipine,
hydrochlorothiazide), a new three-in-one combination product…


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]]> http://www.druganddisease.com/fda-approves-tribenzor-a-new-three-in-one-combination-product-for-the-treatment-of-high-blood-pressure/feed/ 0 FDA Approves Tribenzor, A New Three-In-One Combination Product for the Treatment of High Blood Pressure http://www.druganddisease.com/fda-approves-tribenzor-a-new-three-in-one-combination-product-for-the-treatment-of-high-blood-pressure/ http://www.druganddisease.com/fda-approves-tribenzor-a-new-three-in-one-combination-product-for-the-treatment-of-high-blood-pressure/#comments Mon, 26 Jul 2010 13:07:39 +0000 admin http://www.druganddisease.com/fda-approves-tribenzor-a-new-three-in-one-combination-product-for-the-treatment-of-high-blood-pressure/ PARSIPPANY, N.J., July 26 /PRNewswire/ — Daiichi Sankyo, Inc.
announced today that the U.S. Food and Drug Administration (FDA)
approved Tribenzor (olmesartan medoxomil, amlodipine,
hydrochlorothiazide), a new three-in-one combination product…


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]]> http://www.druganddisease.com/fda-approves-tribenzor-a-new-three-in-one-combination-product-for-the-treatment-of-high-blood-pressure/feed/ 0 Eisai Inc. and Pfizer Inc Announce U.S. FDA Approval for New Higher-Dose Aricept (donepezil HCl) 23 mg Tablet for the Treatment of Moderate-to-Severe Alzheimer’s Disease http://www.druganddisease.com/eisai-inc-and-pfizer-inc-announce-u-s-fda-approval-for-new-higher-dose-aricept-donepezil-hcl-23-mg-tablet-for-the-treatment-of-moderate-to-severe-alzheimers-disease-2/ http://www.druganddisease.com/eisai-inc-and-pfizer-inc-announce-u-s-fda-approval-for-new-higher-dose-aricept-donepezil-hcl-23-mg-tablet-for-the-treatment-of-moderate-to-severe-alzheimers-disease-2/#comments Mon, 26 Jul 2010 12:07:11 +0000 admin http://www.druganddisease.com/eisai-inc-and-pfizer-inc-announce-u-s-fda-approval-for-new-higher-dose-aricept-donepezil-hcl-23-mg-tablet-for-the-treatment-of-moderate-to-severe-alzheimers-disease-2/ WOODCLIFF LAKE, N.J. & NEW YORK–(BUSINESS WIRE)–Jul 24,
2010 – Eisai Inc. and Pfizer Inc announced today that
the U.S. Food and Drug Administration (FDA) approved a new
once-daily, higher-dose Aricept (donepezil HCl) 23 mg tablet for
the…


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]]> http://www.druganddisease.com/eisai-inc-and-pfizer-inc-announce-u-s-fda-approval-for-new-higher-dose-aricept-donepezil-hcl-23-mg-tablet-for-the-treatment-of-moderate-to-severe-alzheimers-disease-2/feed/ 0 Eisai Inc. and Pfizer Inc Announce U.S. FDA Approval for New Higher-Dose Aricept (donepezil HCl) 23 mg Tablet for the Treatment of Moderate-to-Severe Alzheimer’s Disease http://www.druganddisease.com/eisai-inc-and-pfizer-inc-announce-u-s-fda-approval-for-new-higher-dose-aricept-donepezil-hcl-23-mg-tablet-for-the-treatment-of-moderate-to-severe-alzheimers-disease/ http://www.druganddisease.com/eisai-inc-and-pfizer-inc-announce-u-s-fda-approval-for-new-higher-dose-aricept-donepezil-hcl-23-mg-tablet-for-the-treatment-of-moderate-to-severe-alzheimers-disease/#comments Mon, 26 Jul 2010 12:07:11 +0000 admin http://www.druganddisease.com/eisai-inc-and-pfizer-inc-announce-u-s-fda-approval-for-new-higher-dose-aricept-donepezil-hcl-23-mg-tablet-for-the-treatment-of-moderate-to-severe-alzheimers-disease/ WOODCLIFF LAKE, N.J. & NEW YORK–(BUSINESS WIRE)–Jul 24,
2010 – Eisai Inc. and Pfizer Inc announced today that
the U.S. Food and Drug Administration (FDA) approved a new
once-daily, higher-dose Aricept (donepezil HCl) 23 mg tablet for
the…


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]]> http://www.druganddisease.com/eisai-inc-and-pfizer-inc-announce-u-s-fda-approval-for-new-higher-dose-aricept-donepezil-hcl-23-mg-tablet-for-the-treatment-of-moderate-to-severe-alzheimers-disease/feed/ 0 FDA provides Complete Response Letter to NicOx’s New Drug Application for naproxcinod http://www.druganddisease.com/fda-provides-complete-response-letter-to-nicoxs-new-drug-application-for-naproxcinod-2/ http://www.druganddisease.com/fda-provides-complete-response-letter-to-nicoxs-new-drug-application-for-naproxcinod-2/#comments Thu, 22 Jul 2010 13:07:12 +0000 admin http://www.druganddisease.com/fda-provides-complete-response-letter-to-nicoxs-new-drug-application-for-naproxcinod-2/ Sophia Antipolis, France, July 22, 2010-NicOx S.A. today announced the receipt of a Complete
Response Letter from the U.S. Food and Drug Administration (FDA)
related to the New Drug Application (NDA) for naproxcinod.
Naproxcinod is being…


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]]> http://www.druganddisease.com/fda-provides-complete-response-letter-to-nicoxs-new-drug-application-for-naproxcinod-2/feed/ 0 FDA provides Complete Response Letter to NicOx’s New Drug Application for naproxcinod http://www.druganddisease.com/fda-provides-complete-response-letter-to-nicoxs-new-drug-application-for-naproxcinod/ http://www.druganddisease.com/fda-provides-complete-response-letter-to-nicoxs-new-drug-application-for-naproxcinod/#comments Thu, 22 Jul 2010 13:07:12 +0000 admin http://www.druganddisease.com/fda-provides-complete-response-letter-to-nicoxs-new-drug-application-for-naproxcinod/ Sophia Antipolis, France, July 22, 2010-NicOx S.A. today announced the receipt of a Complete
Response Letter from the U.S. Food and Drug Administration (FDA)
related to the New Drug Application (NDA) for naproxcinod.
Naproxcinod is being…


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]]> http://www.druganddisease.com/fda-provides-complete-response-letter-to-nicoxs-new-drug-application-for-naproxcinod/feed/ 0 Theratechnologies: Update on timeline for FDA Action Date http://www.druganddisease.com/theratechnologies-update-on-timeline-for-fda-action-date/ http://www.druganddisease.com/theratechnologies-update-on-timeline-for-fda-action-date/#comments Thu, 22 Jul 2010 13:07:10 +0000 admin http://www.druganddisease.com/theratechnologies-update-on-timeline-for-fda-action-date/ Montréal, Canada – July 20, 2010 -
Theratechnologies announced today that it has received
feedback from the U.S. Food and Drug Administration
(“FDA” or the “Agency”) regarding the
timeline to review tesamorelin’s New Drug Application for…


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]]> http://www.druganddisease.com/theratechnologies-update-on-timeline-for-fda-action-date/feed/ 0 ChemGenex and U.S. FDA Agree on Potential Regulatory Pathway for Omapro http://www.druganddisease.com/chemgenex-and-u-s-fda-agree-on-potential-regulatory-pathway-for-omapro/ http://www.druganddisease.com/chemgenex-and-u-s-fda-agree-on-potential-regulatory-pathway-for-omapro/#comments Wed, 21 Jul 2010 01:59:55 +0000 admin http://www.druganddisease.com/chemgenex-and-u-s-fda-agree-on-potential-regulatory-pathway-for-omapro/ MELBOURNE, Australia & MENLO PARK, Calif.–(BUSINESS
WIRE)–Jul 13, 2010 – ChemGenex Pharmaceuticals Limited announced today it has agreed with the U.S. Food and Drug
Administration (FDA) on a potential regulatory path to progress
Omapro…


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]]> http://www.druganddisease.com/chemgenex-and-u-s-fda-agree-on-potential-regulatory-pathway-for-omapro/feed/ 0 FDA Accepts Afrezza Complete Response Resubmission and Sets Target Action Date http://www.druganddisease.com/fda-accepts-afrezza-complete-response-resubmission-and-sets-target-action-date/ http://www.druganddisease.com/fda-accepts-afrezza-complete-response-resubmission-and-sets-target-action-date/#comments Tue, 20 Jul 2010 14:07:39 +0000 admin http://www.druganddisease.com/fda-accepts-afrezza-complete-response-resubmission-and-sets-target-action-date/ VALENCIA, Calif.–(BUSINESS WIRE)–Jul 20, 2010 – MannKind
Corporation today announced that it has
submitted, and the U.S. Food and Drug Administration (FDA) has
accepted, MannKind’s resubmission of its New Drug Application (NDA)
for Afrezza…


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]]> http://www.druganddisease.com/fda-accepts-afrezza-complete-response-resubmission-and-sets-target-action-date/feed/ 0 Stiefel, a GSK company, Receives FDA Approval of Veltin (clindamycin phosphate and tretinoin) Gel 1.2%/0.025% http://www.druganddisease.com/stiefel-a-gsk-company-receives-fda-approval-of-veltin-clindamycin-phosphate-and-tretinoin-gel-1-20-025/ http://www.druganddisease.com/stiefel-a-gsk-company-receives-fda-approval-of-veltin-clindamycin-phosphate-and-tretinoin-gel-1-20-025/#comments Fri, 16 Jul 2010 23:07:00 +0000 admin http://www.druganddisease.com/stiefel-a-gsk-company-receives-fda-approval-of-veltin-clindamycin-phosphate-and-tretinoin-gel-1-20-025/ Research Triangle Park, N.C. – July 16, 2010 – Stiefel, a GSK company, today announced that the U.S. Food and Drug Administration (FDA) has approved Veltin Gel for the topical treatment of acne vulgaris in patients 12 years and older. Stiefel…


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]]> http://www.druganddisease.com/stiefel-a-gsk-company-receives-fda-approval-of-veltin-clindamycin-phosphate-and-tretinoin-gel-1-20-025/feed/ 0 Vivus Comments on FDA Advisory Committee Panel Meeting on Qnexa (phentermine/topiramate) Controlled Release Capsules for the Treatment of Obesity http://www.druganddisease.com/vivus-comments-on-fda-advisory-committee-panel-meeting-on-qnexa-phenterminetopiramate-controlled-release-capsules-for-the-treatment-of-obesity/ http://www.druganddisease.com/vivus-comments-on-fda-advisory-committee-panel-meeting-on-qnexa-phenterminetopiramate-controlled-release-capsules-for-the-treatment-of-obesity/#comments Fri, 16 Jul 2010 13:07:46 +0000 admin http://www.druganddisease.com/vivus-comments-on-fda-advisory-committee-panel-meeting-on-qnexa-phenterminetopiramate-controlled-release-capsules-for-the-treatment-of-obesity/ MOUNTAIN VIEW, Calif., July 15 /PRNewswire-FirstCall/ — VIVUS,
Inc. today announced that the Endocrinologic and Metabolic Drugs
Advisory Committee of the U.S. Food and Drug Administration (FDA)
voted against the following question: “Based on the…


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]]> http://www.druganddisease.com/vivus-comments-on-fda-advisory-committee-panel-meeting-on-qnexa-phenterminetopiramate-controlled-release-capsules-for-the-treatment-of-obesity/feed/ 0 Human Genome Sciences and Lonza Enter Commercial Manufacturing Agreement for Benlysta, a Potential New Treatment for Systemic Lupus Erythematosus http://www.druganddisease.com/human-genome-sciences-and-lonza-enter-commercial-manufacturing-agreement-for-benlysta-a-potential-new-treatment-for-systemic-lupus-erythematosus/ http://www.druganddisease.com/human-genome-sciences-and-lonza-enter-commercial-manufacturing-agreement-for-benlysta-a-potential-new-treatment-for-systemic-lupus-erythematosus/#comments Fri, 16 Jul 2010 00:00:02 +0000 admin http://www.druganddisease.com/human-genome-sciences-and-lonza-enter-commercial-manufacturing-agreement-for-benlysta-a-potential-new-treatment-for-systemic-lupus-erythematosus/ ROCKVILLE, Md. & BASEL, Switzerland–(BUSINESS WIRE)–Jul
13, 2010 – Human Genome Sciences, Inc. (Nasdaq:HGSI) and Lonza
today announced an agreement for the future commercial supply of
Benlysta (belimumab), which is currently under…


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]]> http://www.druganddisease.com/human-genome-sciences-and-lonza-enter-commercial-manufacturing-agreement-for-benlysta-a-potential-new-treatment-for-systemic-lupus-erythematosus/feed/ 0 Protalix BioTherapeutics Receives PDUFA Date for taliglucerase alfa http://www.druganddisease.com/protalix-biotherapeutics-receives-pdufa-date-for-taliglucerase-alfa/ http://www.druganddisease.com/protalix-biotherapeutics-receives-pdufa-date-for-taliglucerase-alfa/#comments Mon, 12 Jul 2010 16:07:00 +0000 admin http://www.druganddisease.com/protalix-biotherapeutics-receives-pdufa-date-for-taliglucerase-alfa/ CARMIEL, Israel, July 12 /PRNewswire-FirstCall/ — Protalix
BioTherapeutics, Inc. announced today that the
Company’s New Drug Application (NDA) for taliglucerase alfa has
been accepted for review by the U.S. Food and Drug Administration
(FDA)….


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]]> http://www.druganddisease.com/protalix-biotherapeutics-receives-pdufa-date-for-taliglucerase-alfa/feed/ 0