New Drug Applications Archive for 2006

January 3, 2006

• Idenix and Novartis Announce New Drug Application Submitted to the U.S. Food and Drug Administration for Telbivudine for the Treatment of Chronic Hepatitis B

January 9, 2006

• Replidyne Submits NDA for Orapem
• Cellegy Reports Review by Advisory Committee April 2006

January 17, 2006

• Genzyme Provides Update on U.S. Marketing Application for Myozyme

January 25, 2006

• FDA Clarifies Status of Yaz PMDD Application
• Cephalon, Inc. Provides Update on Regulatory Status of Sparlon

January 27, 2006

• New River Pharmaceuticals Announces NRP104 NDA Accepted for Review

January 30, 2006

• Avanir Submits Expanded Neurodex New Drug Application for the Treatment of Involuntary Emotional Expression Disorder

February 2, 2006

• Biologics License Application for Gardasil, Merck's Investigational Cervical Cancer Vaccine, Is On Track

February 7, 2006

• Gardasil, Merck's Investigational Cervical Cancer Vaccine, to Receive Priority Review from the U.S. Food and Drug Administration

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

• GlaxoSmithKline's Topical Antibacterial Retapamulin Accepted for Review by The U.S. Food and Drug Administration

February 15, 2006

• Merck Announces FDA Acceptance of New Drug Application for Januvia, the Company's Investigational Medicine for Type 2 Diabetes

February 16, 2006

• BioSante Pharmaceuticals Announces Bio-E-Gel NDA Submission

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

• Biovest International Submits Amendment Request to FDA for Use of Molecular Remission Data in the Ongoing Pivotal Phase 3 Study to Support Accelerated, Conditional Approval of BiovaxID, a Personalized Anti-Cancer Vaccine for Non-Hodgkin's Lymphoma

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

• Novartis receives approvable letter" from the FDA for zoledronic acid 5 mg in the treatment of Paget's disease of the bone"
• FDA Review Date for Merck's Investigational Shingles Vaccine Extended to May 25, 2006
• Santarus Announces FDA Action Date of February 27, 2006 for Zegerid Capsules NDA

March 1, 2006

• Genasense New Drug Application Accepted for Review by FDA
• BioDelivery Sciences Receives Non-Approvable Notification from FDA on Emezine; Company Has Requested a Meeting with the FDA to Gain Clarity on Notification
• Neupro Receives Approvable Letter from FDA for Early Parkinson's Disease in USA

March 2, 2006

• UCB Submits Biologics License Application to FDA for New Treatment in Crohn's Disease

March 6, 2006

• Tibotec Announces FDA Acceptance for Review of NDA for TMC114

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

• NPS Receives Approvable Letter for Preos NDA
• FDA Declares Daytrana NDA Resubmission to Be Complete Class I Response

March 17, 2006

• Barr Confirms that Additional Clinical Data Is Not Required for Approval of Duramed's Seasonique Extended-Cycle Oral Contraceptive

March 22, 2006

• Novelos Therapeutics Files IND for Novel Hepatitis C Drug; IND Represents Company's Second Clinical Stage Compound

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

• Encysive Pharmaceuticals Receives Approvable Letter From FDA for Thelin

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

• Avanir's Neurodex NDA Accepted with Priority Review for Involuntary Emotional Expression Disorder

April 5, 2006

• Discovery Labs Receives Second Approvable Letter From FDA for Surfaxin for RDS

April 11, 2006

• MoviPrep Issued Approvable Letter by FDA; Potential New Two-Liter Liquid Bowel Cleansing Prep for Colonoscopy

April 12, 2006

• Avastin Filed in US for Treatment of Most Common Form of Lung Cancer

April 13, 2006

• MGI Pharma Announces Submission of Saforis NDA

April 18, 2006

• Neurochem Announces Fibrillex NDA Filed and Granted Priority Review

April 19, 2006

• BioSante Pharmaceuticals Announces FDA Filing and Review of NDA for Bio-E-Gel

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
• Roche Submits Application with FDA to Market C.E.R.A.
• FDA Requests More Information Related to Hexvix NDA

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

• Cephalon Receives Approvable Letter for Nuvigil

May 4, 2006

• Adeza Submits New Drug Application For Gestiva to Prevent Preterm Births

May 9, 2006

• Pharmacyclics to Submit New Drug Application for Xcytrin for Treatment of Lung Cancer Patients With Brain Metastases
• Hana Biosciences Reaffirms Expected Timing of First NDA Filing

May 16, 2006

• Neurocrine Receives Approvable Letter for indiplon Capsules and Non-Approvable for indiplon Tablets for the Treatment of Insomnia

May 17, 2006

• Shire Provides Update on U.S. Marketing Application of Elaprase

May 18, 2006

• FDA Advisory Committee Votes Unanimously That Clinical Data Support the Efficacy and Safety of Gardasil

May 25, 2006

• Encysive Pharmaceuticals Submits Complete Response to FDA for Thelin New Drug Application

May 26, 2006

• FDA Accepts Submission for NitroMist as Complete Response

May 31, 2006

• Cardiome Announces Refusal to File Decision By the FDA
• Adolor’s Complete Response to Approvable Letter Accepted for Review by FDA

June 1, 2006

• CTI and FDA Agree on NDA Filing Strategy for Xyotax

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

• FDA Grants Adeza Priority Review for Gestiva to Prevent Preterm Births

June 7, 2006

• Zolinza, Merck's Investigational Medicine for Advanced Cutaneous T-Cell Lymphoma (CTCL), to Receive Priority Review from U.S. Food and Drug Administration

June 9, 2006

• Pozen Inc. and GlaxoSmithKline Report Receipt of Approvable Letter for Investigational Migraine Treatment

June 12, 2006

• Saforis NDA Accepted by U.S. FDA for Priority Review

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

• FDA Informs Avanir of Revised Neurodex NDA Action Date

June 20, 2006

• EMD Pharmaceuticals Announces Submission of New Drug Application for Cyanokit for Treatment of Cyanide Poisoning

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

• Wyeth Receives Approvable Letter From the FDA for Lybrel

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
• EPIX Pharmaceuticals Files Appeal with FDA Regarding Vasovist Approvable Letters
• DOR BioPharma Provides Regulatory Update on orBec
• FDA Extends PDUFA Date for Polyphenon E Ointment to October 31, 2006

July 6, 2006

• ISTA Pharmaceuticals Files NDA for T-Pred
• Valera Pharmaceuticals Submits NDA for Supprelin-LA
• FDA Accepts Adeza NDA Filing for Gestiva to Prevent Preterm Births

July 10, 2006

• FDA Issues Approvable Letter to Cellegy Pharmaceuticals for Cellegesic

July 12, 2006

• GPC Biotech Submits Non-Clinical Section of Rolling NDA for Satraplatin

July 13, 2006

• Nuvo’s Pennsaid NDA Resubmission Accepted for Review by U.S. FDA

July 17, 2006

• Cangene’s Human Growth Hormone Drug Submission is Accepted for Review by FDA

July 18, 2006

• Adeza Announces August 29 FDA Advisory Committee Date to Review Gestiva to Prevent Preterm Births

July 21, 2006

• Shire Announces Filing of SPD465 for the Treatment of Adult ADHD

July 24, 2006

• FDA Issues Approvable Letter for Thelin; One Outstanding Item Remains

July 27, 2006

• Genta Announces FDA's Oncology Drug Advisory Committee Will Review Genasense as Treatment for Chronic Lymphocytic Leukemia
• UCB, Inc. Submits New Drug Application to FDA for Xyzal
• New Seasonal and Perennial Rhinitis Intranasal Treatment Submitted for U.S. and European Marketing Approval

July 28, 2006

• FDA Extends Review of EPIX Pharmaceuticals’ Appeal of Vasovist Approvable Letters

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

• Cephalon Receives Non-Approvable Letter on Sparlon

August 11, 2006

• Neurochem Receives Approvable Letter for Eprodisate (Kiacta) for Treatment of AA Amyloidosis

August 18, 2006

• Eli Lilly and Company Announces Approvable Letter Issued by FDA for Arxxant

August 22, 2006

• FDA Cancels Advisory Committee Meeting to Review Desvenlafaxine Succinate Data for Major Depressive Disorder

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

• Re-formatted Data Submission Results in Extension of FDA Review for Desvenlafaxine Succinate
• FDA Advisory Committee Recommends Approval of Adeza’s NDA for Gestiva to Prevent Preterm Birth

August 30, 2006

• FDA Accepts for Review NDA Filing for Zensana (Ondansetron HCl) Oral Spray

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

• Valera Pharmaceuticals Receives PDUFA Date for Supprelin-LA

September 8, 2006

• Shire Provides Update on U.S. Marketing Application of Mesavance (mesalamine) With MMX Technology

September 18, 2006

• GlaxoSmithKline Seeks U.S. Approval for Tykerb (lapatinib ditosylate) for the Treatment of Advanced Breast Cancer

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

• DOR BioPharma Files New Drug Application with FDA to Market orBec for GI GVHD

September 28, 2006

• Discovery Labs Updates Progress On Manufacturing Remediation and Surfaxin FDA Regulatory Matters

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

• VIVUS Submits New Drug Application With U.S. Food and Drug Administration for EvaMist
• Alfacell Completes Non-Clinical Section of Rolling NDA for Lead Anticancer Drug Onconase

October 5, 2006

• Inspire Continues Discussions with FDA on Dry Eye Program

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

• Solvay Pharmaceuticals and Wyeth Announce Submission of New Drug Application for Bifeprunox to Treat Schizophrenia
• MGI Pharma Receives Approvable Letter for Saforis (Glutamine) Powder in UpTec for Oral Suspension

October 16, 2006

• Neurochem submits a complete response to FDA approvable letter for Kiacta

October 23, 2006

• U.S. Food and Drug Administration Issues Non-Approvable Letter for Faropenem
• Adeza Receives FDA Approvable Letter for Gestiva

October 26, 2006

• IDM Pharma Submits New Drug Application to the FDA for Junovan (mifamurtide) in the Treatment of Osteosarcoma

October 30, 2006

• FDA Extends Review Period for Genasense New Drug Application in Chronic Lymphocytic Leukemia

October 31, 2006

• Avanir Receives FDA Approvable Letter for Zenvia for the Treatment of Involuntary Emotional Expression Disorder

November 2, 2006

• Tercica Reports Somatuline Autogel NDA for Acromegaly Submitted to FDA
• Encysive Submits Complete Response to FDA For Thelin New Drug Application

November 6, 2006

• FDA Issues Approvable Letter for Entereg (alvimopan) for POI

November 7, 2006

• Cephalon Inc. Granted Composition of Matter Patent Covering Nuvigil

November 9, 2006

• Pozen Submits Full Response to FDA Approvable Letter For Trexima

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

• FDA Grants Priority Review for Soliris (eculizumab) BLA for Treatment of Paroxysmal Nocturnal Hemoglobinuria

November 16, 2006

• FDA Expands Use of Herceptin for Early Stage Breast Cancer After Primary Therapy

November 20, 2006

• Somaxon Pharmaceuticals’ Silenor Demonstrates Positive Results in its Third Phase 3 Clinical Trial in Insomnia

November 21, 2006

• US FDA Grants Immtech's Oral Drug Candidate Pafuramidine (DB289) Orphan Drug Status for Treatment of PCP

November 22, 2006

• FDA Approves First Generic Ondansetron Injection

November 27, 2006

• Anesiva Announces Filing of New Drug Application for Zingo to Reduce Pain Associated with Needle Insertion Procedures in Children

November 28, 2006

• Daiichi Sankyo, Inc. Announces Filing of NDA for Amlodipine Besylate / Olmesartan Medoxomil Combination for the Treatment of Hypertension

December 1, 2006

• Merck Announces Janumet, the Trademark for its Investigational Combination Therapy of Sitagliptin Phosphate and Metformin for Type 2 Diabetes

December 8, 2006

• Rimonabant Update in the United States

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

• Pozen Expects to Submit Revised Response to Trexima Approvable Letter by Year End

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
• Genta Receives Non-Approvable Notice for Application of Genasense in Patients With Chronic Lymphocytic Leukemia
• Encysive Pharmaceuticals Submits Response to FDA For Thelin New Drug Application
• Roche Offers the FDA Additional Mircera Data

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
• New River Pharmaceuticals and Shire Receive Approvable Letter for Vyvanse
• Allergan Announces FDA Issues Approvable Letter for Combigan 0.2%/0.5%

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

• IDM Pharma Announces Acceptance for Review of the NDA for Junovan (Mifamurtide)

December 27, 2006

• Adams Respiratory Therapeutics Seeks Approval for New Prescription Cough Suppressant

December 28, 2006

• FDA Accepts Encysive’s Complete Response to Thelin New Drug Application

December 29, 2006

• Nuvo Receives Approvable Letter From U.S. FDA for Pennsaid