New Drug Applications Archive for 2006
January 3, 2006
January 9, 2006
January 17, 2006
January 25, 2006
- FDA Clarifies Status of Yaz PMDD Application
- Cephalon, Inc. Provides Update on Regulatory Status of Sparlon
January 27, 2006
January 30, 2006
February 2, 2006
February 7, 2006
February 13, 2006
- Sepracor's Arformoterol NDA Filed by FDA; Drug Candidate for Chronic Obstructive Pulmonary Disease Moves Into Formal Review
- Neurochem Submits NDA for Fibrillex
- Schering-Plough Reports Garenoxacin NDA Accepted for FDA Review
February 14, 2006
February 15, 2006
February 16, 2006
February 17, 2006
- Alkermes Announces Submission of Complete Response to FDA for Vivitrol New Drug Application
- Sanofi-aventis Received from the FDA an Approvable Letter for Rimonabant for Weight Management and a Non Approvable Letter for Smoking Cessation
February 22, 2006
February 23, 2006
- Replidyne and Forest Laboratories Announce FDA Acceptance for Review of New Drug Application for Oral Antibiotic Faropenem Medoxomil
- Replidyne and Forest Announce FDA Acceptance for Review of NDA
February 24, 2006
- FDA Review Date for Merck's Investigational Shingles Vaccine Extended to May 25, 2006
- Novartis receives approvable letter" from the FDA for zoledronic acid 5 mg in the treatment of Paget's disease of the bone"
- Santarus Announces FDA Action Date of February 27, 2006 for Zegerid Capsules NDA
March 1, 2006
- BioDelivery Sciences Receives Non-Approvable Notification from FDA on Emezine; Company Has Requested a Meeting with the FDA to Gain Clarity on Notification
- Genasense New Drug Application Accepted for Review by FDA
- Neupro Receives Approvable Letter from FDA for Early Parkinson's Disease in USA
March 2, 2006
March 6, 2006
March 7, 2006
- Altana Submitted New Drug Applications For Ciclesonide Nasal Spray in the U.S. and Canada; Major Milestone in Broadening the Ciclesonide Product Platform
- FDA Grants Priority Review for Bristol-Myers Squibb's Investigational Oncology Treatment Dasatinib
March 10, 2006
- FDA Declares Daytrana NDA Resubmission to Be Complete Class I Response
- NPS Receives Approvable Letter for Preos NDA
March 17, 2006
March 22, 2006
March 23, 2006
- GlaxoSmithKline Submits Biologics License Application for FDA Approval of FluLaval
- FDA Advisory Committee Recommends Against Approval of Sparlon for Attention Deficit/Hyperactivity Disorder in Children and Adolescents
March 24, 2006
March 28, 2006
- Inspire Announces Outcome of FDA Meeting on Dry Eye Program
- Inspire Announces Outcome of FDA Meeting on Dry Eye Program
March 29, 2006
- NPS Updates Status of Preos NDA
- Axcan submits FDA amendment to its new drug application for Helizide
March 30, 2006
- Amgen and Abgenix Complete Biologics License Application for FDA Approval of Panitumumab
- New drug application for Galvus, an innovative oral therapy for people with type 2 diabetes, accepted for review by FDA
March 31, 2006
- New Drug Application Submitted For RSD1235
- Prestwick Pharmaceuticals Receives FDA Approvable Letter for Xenazine (Tetrabenazine) for Treatment of Chorea Associated with Huntington's Disease
April 4, 2006
April 5, 2006
April 11, 2006
April 12, 2006
April 13, 2006
April 18, 2006
April 19, 2006
April 20, 2006
- New Drug Application (NDA) for Rasilez (Aliskiren), an Innovative Oral Renin Inhibitor to Treat High Blood Pressure, Accepted for Review by the US FDA
- FDA Requests More Information Related to Hexvix NDA
- Roche Submits Application with FDA to Market C.E.R.A.
April 27, 2006
- InSite Vision Meets With the FDA on Pre-NDA Discussions
- US Submission of Exforge Accepted for Review by the FDA
May 1, 2006
May 4, 2006
May 9, 2006
- Hana Biosciences Reaffirms Expected Timing of First NDA Filing
- Pharmacyclics to Submit New Drug Application for Xcytrin for Treatment of Lung Cancer Patients With Brain Metastases
May 16, 2006
May 17, 2006
May 18, 2006
May 25, 2006
May 26, 2006
May 31, 2006
- Adolor’s Complete Response to Approvable Letter Accepted for Review by FDA
- Cardiome Announces Refusal to File Decision By the FDA
June 1, 2006
June 2, 2006
- Bristol-Myers Squibb Issues Statement on Oncologic Drugs Advisory Committee Vote in Favor of Investigational Drug Dasatinib
- FDA Says Tibolone Not Approvable as a Menopause Treatment in the U.S.
June 5, 2006
June 7, 2006
June 9, 2006
June 12, 2006
June 15, 2006
- Neurocrine Completes Review of Indiplon Action Letters
- FDA Grants Class 1 Review to Encysive Pharmaceuticals’ Complete Response to Thelin NDA
June 19, 2006
June 20, 2006
June 26, 2006
- Wyeth Submits Two New Drug Applications for Women's Health Therapies
- Wyeth Submits Two NDAs for Women’s Health Therapies
- Wyeth Submits Two New Drug Applications for Women's Health Therapies
June 28, 2006
June 29, 2006
- InSite Vision Announces Submission of AzaSite NDA
- Cephalon Receives Approvable Letter for Fentora (fentanyl buccal tablet) for Management of Breakthrough Pain in Patients with Cancer
June 30, 2006
- Hana Biosciences Submits Zensana NDA to the FDA
- DOR BioPharma Provides Regulatory Update on orBec
- EPIX Pharmaceuticals Files Appeal with FDA Regarding Vasovist Approvable Letters
- FDA Extends PDUFA Date for Polyphenon E Ointment to October 31, 2006
July 6, 2006
- ISTA Pharmaceuticals Files NDA for T-Pred
- FDA Accepts Adeza NDA Filing for Gestiva to Prevent Preterm Births
- Valera Pharmaceuticals Submits NDA for Supprelin-LA
July 10, 2006
July 12, 2006
July 13, 2006
July 17, 2006
July 18, 2006
July 21, 2006
July 24, 2006
July 27, 2006
- New Seasonal and Perennial Rhinitis Intranasal Treatment Submitted for U.S. and European Marketing Approval
- UCB, Inc. Submits New Drug Application to FDA for Xyzal
- Genta Announces FDA's Oncology Drug Advisory Committee Will Review Genasense as Treatment for Chronic Lymphocytic Leukemia
July 28, 2006
July 31, 2006
- Pozen to Submit Full Response to Trexima Approvable Letter During the Fourth Quarter
- Merck Announces FDA Acceptance of NDA for MK-0431A
August 9, 2006
August 11, 2006
August 18, 2006
August 22, 2006
August 24, 2006
- Dendreon Submits Clinical and Non-Clinical Sections of Rolling BLA to FDA for Provenge
- Shire Announces NDA Submission of Guanfacine Extended Release for the Treatment of ADHD in Children and Adolescents
August 28, 2006
- InSite Vision Announces FDA Acceptance of New Drug Application for Review
- Epix Pharmaceuticals Receives Response from the FDA Regarding Appeal of Vasovist Approvable Letters
August 29, 2006
- FDA Advisory Committee Recommends Approval of Adeza’s NDA for Gestiva to Prevent Preterm Birth
- Re-formatted Data Submission Results in Extension of FDA Review for Desvenlafaxine Succinate
August 30, 2006
September 5, 2006
- Neurocrine Reports Results of FDA End-of-Review Meeting on Indiplon Capsules NDA
- Briefing Documents Posted for FDA Committee Review of Genasense New Drug Application
September 7, 2006
September 8, 2006
September 18, 2006
September 20, 2006
- Alexion Pharmaceuticals Submits Biologics License Application for Soliris (eculizumab)
- Access Pharmaceuticals Announces the Filing of an FDA 510(K) Application for MuGard
September 22, 2006
September 28, 2006
September 29, 2006
- Lilly Announces FDA Requirement of Additional Clinical Trial Before Ruboxistaurin Could Be Approved for Treatment of Diabetic Retinopathy
- FDA Issues Approvable Letter for Paliperidone ER for the Treatment of Schizophrenia
October 2, 2006
- Alfacell Completes Non-Clinical Section of Rolling NDA for Lead Anticancer Drug Onconase
- VIVUS Submits New Drug Application With U.S. Food and Drug Administration for EvaMist
October 5, 2006
October 6, 2006
- FDA Issues Approvable Letter for NRP104 (lisdexamfetamine dimesylate) for the Treatment of ADHD
- Wyeth Submits NDA and MAA for Torisel for the Treatment of Advanced Renal Cell Carcinoma
October 12, 2006
- MGI Pharma Receives Approvable Letter for Saforis (Glutamine) Powder in UpTec for Oral Suspension
- Solvay Pharmaceuticals and Wyeth Announce Submission of New Drug Application for Bifeprunox to Treat Schizophrenia
October 16, 2006
October 23, 2006
- Adeza Receives FDA Approvable Letter for Gestiva
- U.S. Food and Drug Administration Issues Non-Approvable Letter for Faropenem
October 26, 2006
October 30, 2006
October 31, 2006
November 2, 2006
- Encysive Submits Complete Response to FDA For Thelin New Drug Application
- Tercica Reports Somatuline Autogel NDA for Acromegaly Submitted to FDA
November 6, 2006
November 7, 2006
November 9, 2006
November 10, 2006
- Janssen, L.P. Selects Invega (paliperidone) Extended Release Tablets as Brand Name for Its Investigational Atypical Antipsychotic
- Merck Responds to FDA-Issued Approvable Letters for Arcoxia (etoricoxib)
November 13, 2006
- Dendreon Completes Submission of Biologics License Application to FDA for Provenge in Hormone Refractory Prostate Cancer
- Novartis announces three-month extension of US regulatory review for Galvus to assess recently available clinical data
November 14, 2006
November 16, 2006
November 20, 2006
November 21, 2006
November 22, 2006
November 27, 2006
November 28, 2006
December 1, 2006
December 8, 2006
December 12, 2006
- U.S. Food and Drug Administration Files New Drug Application for Bifeprunox, Submitted in October 2006
- VIVUS Announces FDA Acceptance of EvaMist NDA Submission
December 13, 2006
December 14, 2006
- Novartis Announces Three-Month Extension of US Regulatory Review Period for Tekturna
- Encysive Expects to Submit Revised Response to Thelin Approvable Letter Within Several Days
- Epix Pharmaceuticals to File Appeal with the Center for Drug Evaluation and Research for Vasovist
December 15, 2006
- New Drug Application Submitted for Investigational Antibiotic Doripenem
- Encysive Pharmaceuticals Submits Response to FDA For Thelin New Drug Application
- Roche Offers the FDA Additional Mircera Data
- Genta Receives Non-Approvable Notice for Application of Genasense in Patients With Chronic Lymphocytic Leukemia
December 18, 2006
- ZymoGenetics Submits BLA to the FDA for rhThrombin as an Aid to Controlling Bleeding During Surgery
- Cardiome and Astellas Pharma US, Inc. Announce Re-Submission of NDA for Vernakalant (IV)
December 19, 2006
- FDA Grants Torisel NDA Priority Review Status
- Gilead Submits NDA To U.S. FDA for Ambrisentan for the Treatment of Pulmonary Arterial Hypertension
December 21, 2006
- Genzyme Files for Approval of Sevelamer Carbonate for Patients on Dialysis
- Allergan Announces FDA Issues Approvable Letter for Combigan 0.2%/0.5%
- New River Pharmaceuticals and Shire Receive Approvable Letter for Vyvanse
December 22, 2006
- GSK Receives Approvable Letter for Topical Antibiotic, Altabax (retapamulin ointment), 1%
- Pharmacyclics Submits NDA for Xcytrin for the Treatment of Lung Cancer Brain Metastases
December 26, 2006
December 27, 2006
December 28, 2006
December 29, 2006
New drug applications archive
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
- 2011
- 2010
- 2009
- 2008
- 2007
- 2006
- 2005
- 2004
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.