New Drug Applications Archive for 2005

January 3, 2005

• Insmed Submits New Drug Application -NDA- to Seek Regulatory Approval of SomatoKine for the Treatment of Growth Hormone Insensitivity Syndrome
• Dacogen NDA Accepted for Filing by FDA
• SuperGen Announces Withdrawal of Orathecin NDA

January 5, 2005

• H3 Pharma Receives Approvable Letter from FDA for Sanvar for Esophageal Variceal Bleeding
• Valeant Pharmaceuticals Submits Complete Response to FDA Approvable Letter for Zelapar

January 6, 2005

• Savient Pharmaceuticals, Inc. Submits New Drug Application for Soltamox to the U.S. Food and Drug Administration

January 7, 2005

• Berlex Receives Approvable Letter for Bonefos (Clodronate) for Adjuvant Treatment of Breast Cancer

January 10, 2005

• Adolor Announces FDA Update

January 11, 2005

• Neurocrine Biosciences Announces Plans to Resubmit Indiplon Modified Release New Drug Application (NDA)

January 14, 2005

• FDA has completed its review of the NDA for MS-325

January 18, 2005

• Orphan Medical Submits Xyrem sNDA to Include Improvement in Other Primary Symptoms of Narcolepsy

January 19, 2005

• FDA Issues Not Approvable Letter for Marqibo

January 24, 2005

• Johnson & Johnson Completes Submission of Tipifarnib NDA to FDA

January 28, 2005

• FDA Grants Tygacil (Tigecycline) NDA Priority Review Status
• Schwarz Pharma Re-Submits NDA for Rotigotine in the U.S.

February 1, 2005

• Advanced Magnetics' Combidex to be Reviewed by FDA Oncologic Drugs Advisory Committee

February 3, 2005

• FDA Accepts NitroMed's New Drug Application Resubmission for BiDil; Submission Granted a June 23, 2005 PDUFA Date

February 7, 2005

• Neurocrine Biosciences Announces Resubmission Status of Indiplon
• NPS Provides Update on Preos NDA Process and Timing

February 11, 2005

• FDA Agrees to File Abbott's New Drug Application for Xinlay (Atrasentan) to Treat Metastatic Hormone-Refractory Prostate Cancer

February 14, 2005

• Discovery Labs Receives Approvable Letter from FDA for Surfaxin for Respiratory Distress Syndrome in Premature Infants

February 24, 2005

• Vicuron Pharmaceuticals Granted Priority Review of Dalbavancin NDA by FDA in Complicated Skin and Soft Tissue Infections

February 25, 2005

• FDA Extends PDUFA Action Date for Nebivolol Tablets to May 31, 2005

February 28, 2005

• Tercica Submits New Drug Application for Increlex as a Treatment for Short Stature Caused by Primary IGF-1 Deficiency

March 1, 2005

• Biovail, Depomed Receive Approvable Letter from FDA for Extended-Release Glumetza for Type II Diabetes

March 2, 2005

• Pfizer and the Sanofi-Aventis Group Seek Approval to Market Exubera in the United States

March 3, 2005

• Oncologic Drugs Advisory Committee Recommends Against Approval of a Broad Indication For Combidex

March 9, 2005

• AGI Dermatics 'Breakthrough' Anti-Aging Cream is Singled out by Three Major Media Outlets -- CBS's the Early Show, Prevention Magazine, and Dermatology Times

March 10, 2005

• FDA Accepts for Review Insmed's NDA for SomatoKine for the Treatment of Growth Hormone Insensitivity Syndrome

March 11, 2005

• Bristol-Myers Squibb Statement on FDA Advisory Committee Vote on Baraclude (entecavir), an Investigational Oral Antiviral Agent for Chronic Hepatitis B

March 14, 2005

• La Jolla Pharmaceutical Announces Outcome of Recent FDA Discussions

March 15, 2005

• FDA Advisory Panel Recommends Licensure of Sanofi Pasteur's Adacel Vaccine for Combined Protection against Tetanus, Diphtheria and Pertussis
• GlaxoSmithKline Receives Unanimous Favorable Recommendation by FDA Advisory Committee for Boostrix
• ID Biomedical to Pursue U.S. Accelerated Approval Process for its Influenza Vaccine - Fluviral

March 24, 2005

• Advanced Magnetics, Inc. Receives Approvable Letter From FDA For Combidex

March 28, 2005

• Halozyme Therapeutics Files NDA for Enhanze SC

March 31, 2005

• Cephalon Files New Drug Application for Nuvigil

April 1, 2005

• Alkermes Announces Submission of New Drug Application for Vivitrex for Treatment of Alcohol Dependence
• FDA Requests Further Data on Cilansetron, Solvay's Proposed Treatment for Irritable Bowel Syndrome with Diarrhea Predominance (IBS-D)
• Sucampo Submits New Drug Application for Lubiprostone, an Investigational Compound for the Treatment of Chronic Idiopathic Constipation

April 8, 2005

• Revlimid New Drug Application Submitted to FDA for Review

April 11, 2005

• Merck Submits Biologics License Application to FDA for Rotateq, an Investigational Vaccine for Rotavirus

April 13, 2005

• Depomed, Biovail Update Status of Glumetza NDA

April 14, 2005

• Neurocrine Announces Submission of New Drug Application for Indiplon Capsules

April 18, 2005

• Salvat Seeks FDA Approval for its Cetraxal Otic (Ciprofloxacin Otic) 0.2% Solution, for the Treatment of External Otitis
• FDA Extends PDUFA Date for Megace ES to July 29, 2005
• Cellegy Responds to FDA Inquiries Concerning Cellegesic

April 20, 2005

• DOR BioPharma to File NDA for orBec

April 26, 2005

• Barr's Receives Not Approvable Letter for Bijuva Vaginal Cream

April 28, 2005

• Santarus Submits New Drug Application for Zegerid Capsules; NDA for First Immediate-Release PPI Capsule Submitted Ahead of Previously Announced Third Quarter Target

April 29, 2005

• FDA Schedules Advisory Committee Review of BiDil

May 2, 2005

• BDSI Announces Submission of NDA for Emezine; First Transmucosal Product for the Treatment of Nausea and Vomiting
• FDA Accepts Tercica's Increlex New Drug Application With Priority Review for the Treatment of Short Stature
• Merck Submits Biologics License Application to FDA for Zostavax, an Investigational Vaccine for Shingles and Shingles-Associated Nerve Pain

May 3, 2005

• Novartis Files Exjade New Drug Applications for Treatment of Chronic Iron Overload Due to Blood Transfusions
• InKine Announces Submission of a New Drug Application -NDA- for Its Next Generation Purgative Product - INKP-102

May 5, 2005

• Cellegy Reports New FDA Target Response Date of June 15

May 8, 2005

• Teva Receives Follow-up Approvable Letter from FDA Regarding Agilect

May 11, 2005

• Further Trial Data Awaited for Bonefos in the U.S.
• Vicuron Pharmaceuticals Announces Extension of FDA Review of Dalbavancin New Drug Application

May 19, 2005

• FDA Antiviral Drugs Advisory Committee Recommends Accelerated Approval for Investigational Anti-HIV Drug Tipranavir

May 23, 2005

• EPIX Submits Response to FDA Approvable Letter

May 24, 2005

• Alcon Receives Approvable Letter from FDA for Retaane Suspension

May 25, 2005

• GlaxoSmithKline Submits Biologics License Application for FDA Approval of Fluarix
• Barrier Therapeutics Receives Not Approvable Letter From the FDA for Zimycan
• Encysive Pharmaceuticals Submits New Drug Application for Thelin

May 26, 2005

• Halozyme Therapeutics Announces FDA Acceptance of Hylenex NDA
• Neurocrine Announces Submission of New Drug Application for Indiplon Tablets

May 27, 2005

• Alkermes Announces Priority Review Granted For Vivitrex (Naltrexone Long-Acting Injection) NDA Submission
• Santarus Submits New Drug Application for Zegerid Chewable Tablets
• Biovail Receives Tentative Approval From FDA for Zolpidem ODT for Sleep Disorders

May 31, 2005

• Vicuron Pharmaceuticals Files Amendment to Anidulafungin New Drug Application (NDA) for Treatment of Esophageal Candidiasis

June 1, 2005

• Allergan Receives Written Response from FDA on Oral Tazarotene
• Inspire Submits Amendment to New Drug Application for Diquafosol for the Treatment of Dry Eye
• Mylan Laboratories Receives Approvable Letter For Its Next Generation Beta-Blocker Nebivolol

June 2, 2005

• NovaDel Pharma Receives Approvable Letter from the FDA for NitroMist - nitroglycerin lingual aerosol
• Vicuron Pharmaceuticals Receives Issued Patent for Dalbavancin Dosing by U.S. Patent and Trademark Office

June 7, 2005

• Revlimid (lenalidomide) New Drug Application Accepted for Review by FDA

June 10, 2005

• FDA Extends PDUFA Date for SomatoKine to October 3, 2005
• SALVAT Files NDA for its Cetraxal Otic - Ciprofloxacin Otic- 0.2% Solution, for the Treatment of External Otitis

June 13, 2005

• U.S. FDA Agrees to Rolling New Drug Application for Virulizin
• Connetics Receives FDA Non-Approvable Letter for Velac

June 14, 2005

• Neurocrine Announces Acceptance of New Drug Application for Indiplon Capsules

June 15, 2005

• Organizations Unite to Support BiDil's Approval for Heart Failure, Rebuff Designation as 'Race-Only' Drug

June 16, 2005

• FDA Advisory Committee Recommends Approval for NitroMed's BiDil to Treat Black Patients With Heart Failure
• Somerset Files Response to Emsam Action Letter

June 17, 2005

• Merck Provides Status Update on Ongoing Arcoxia Trials

June 21, 2005

• FDA Grants Priority Review for Revlimid NDA for Treatment of Low- and Intermediate- Risk MDS With Deletion 5q Chromosomal Abnormality
• Organon Receives Approvable Letter From FDA for Contraceptive Implant

June 22, 2005

• FDA Grants Priority Review for Exjade for the Treatment of Chronic Iron Overload Due to Blood Transfusions

June 23, 2005

• Rimonabant Accepted for Filing By the FDA

June 28, 2005

• Santarus Announces FDA Acceptance of New Drug Application For Zegerid Capsules; FDA Action Expected in Early 2006 on NDA for First Immediate-Release Proton Pump Inhibitor in Capsule Formulation

June 29, 2005

• FDA Sets August 4, 2005 for Advisory Committee Meeting to Consider Tardive Dyskinesia Risk with MT 100
• Merck Announces that FDA Has Accepted For Review Biologics License Applications for Rotateq and Zostavax
• Merck Announces that FDA Has Accepted For Review Biologics License Applications for Rotateq and Zostavax
• Penwest Receives Non-Approvable Letter from FDA for PW2101

June 30, 2005

• FDA Agrees to File and Review NDA for Fibrillex
• Halozyme Therapeutics Announces Submission of Investigational New Drug Application
• Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Receives Not Approvable Letter From FDA for Tipifarnib Based on Phase II Data
• Avanir Submits NDA for Neurodex
• Cellegy Reports Status of Response Date for FDA Review
• Genta Initiates New Drug Application for Genasense in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia
• Takeda Submits New Drug Application for Combination Type 2 Diabetes Medication Containing Pioglitazone HCl and Glimepiride

July 11, 2005

• Preos New Drug Application Accepted for Review by FDA
• Bayer and Onyx Complete Filing of New Drug Application for Sorafenib for Individuals with Advanced Renal Cell Carcinoma

July 14, 2005

• Encysive Announces PDUFA Date for Thelin New Drug Application in Pulmonary Arterial Hypertension

July 15, 2005

• FDA Requests Additional Data on Pulminiq (Cyclosporine, USP) Inhalation Solution; Agency Action Letter States that Pulminiq is ''Approvable'' But Additional Study is Required

July 18, 2005

• Upsher-Smith Laboratories Disappointed in FDA's Decision to Delay Approval of Affordable Osteoporosis Therapy

July 20, 2005

• BDSI Announces Acceptance of Emezine NDA for Review By FDA

July 22, 2005

• Adolor Receives FDA Approvable Letter for Entereg

July 26, 2005

• InKine Announces the Acceptance for Filing of Its New Drug Application (NDA) for Its Next Generation Purgative Product -- INKP-102
• Neurocrine Announces Acceptance of New Drug Application for Indiplon Tablets
• Shire and Noven Resubmitted NDA for MTS, a Candidate Treatment for Pediatric ADHD Patients
• Santarus Announces FDA Acceptance of New Drug Application For Zegerid Chewable Tablets

July 27, 2005

• CV Therapeutics Submits Amendment to Ranexa (ranolazine)
• Wyeth's New Drug Application for New Oral Contraceptive With Uninterrupted Dosing Regimen Accepted for Filing at FDA
• Wyeth’s NDA for New Oral Contraceptive Accepted for Filing at FDA

July 29, 2005

• Genzyme Submits BLA for Myozyme for Treatment of Pompe Disease
• Discovery Labs Submits Response to FDA Approvable Letter for Surfaxin for RDS in Premature Infants

August 1, 2005

• BioMarin Files New Drug Application for Orapred ODT
• CollaGenex Pharmaceuticals Files New Drug Application for Oracea

August 2, 2005

• Lilly Will Submit Arxxant to FDA in 2005

August 5, 2005

• POZEN Provides Results of FDA Advisory Committee Meeting on MT 100 (Naproxen Sodium and Metoclopramide Hydrochloride)

August 8, 2005

• POZEN Submits New Drug Application for Trexima (Sumatriptan Succinate and Naproxen Sodium) for the Acute Treatment of Migraine

August 10, 2005

• Pfizer Submits New Drug Application for Sutent to FDA

August 14, 2005

• Tercica Announces Insmed Files Citizen Petition with the FDA to Deny Approval of Increlex NDA

August 15, 2005

• Discovery Labs Provides Status of Previously Submitted Response to FDA Approvable Letter for Surfaxin

August 17, 2005

• Tercica Addresses Citizen Petition Filed by Insmed

August 18, 2005

• Barr Receives Approvable Letter for Duramed's Seasonique Extended-Cycle Oral Contraceptive
• Vicuron Pharmaceuticals Files New Drug Application (NDA) for Anidulafungin for Treatment of Invasive Candidiasis/Candidemia

August 19, 2005

• Discovery Labs Provides Update on Status of Response to FDA Approvable Letter for Surfaxin

August 22, 2005

• Neurochem Initiates Submission of NDA for Fibrillex

August 24, 2005

• CTI Plans to Submit Marketing Applications for Xyotax

August 29, 2005

• Femara Granted FDA Priority Review for New Indication as Adjuvant Treatment for Postmenopausal Women with Early Breast Cancer

August 30, 2005

• ImClone Systems Incorporated and Bristol-Myers Squibb File Supplemental Biologics License Application for Erbitux for Treatment of Head and Neck Cancer

September 1, 2005

• Approvable Letter Received from the FDA for Dacogen (Decitabine) Injection for the Treatment of MDS.

September 6, 2005

• Bristol-Myers Squibb Statement on FDA Advisory Committee Vote on Orencia (Abatacept), an Investigational Selective Modulator of T-Cell Co-Stimulation for Rheumatoid Arthritis
• Cephalon Files New Drug Application for OraVescent Fentanyl for the Management of Breakthrough Pain in Cancer Patients

September 8, 2005

• FDA Advisory Committee Recommends Approval of Exubera for Use in Adults With Type 1 and 2 Diabetes

September 9, 2005

• Bristol-Myers Squibb and Merck Joint Statement on FDA Advisory Committee Vote on Pargluva (Muraglitazar), an Investigational Oral Treatment for Type 2 Diabetes

September 13, 2005

• Eisai Submits New Drug Application to the FDA for Anti-epileptic Drug Rufinamide
• FDA Advisory Committee Does Not Recommend Approval of Xinlay (atrasentan)
• Pfizer Statement on Lasofoxifene
• FDA and Celgene Revlimid Briefing Documents for Advisory Committee Meeting Available Online

September 14, 2005

• Dendreon Announces Plans to Submit BLA
• FDA Advisory Committee Recommends Accelerated Approval of GlaxoSmithKline's Arranon (nelarabine) Injection
• FDA Oncologic Drugs Advisory Committee Recommends Revlimid for Full Approval
• Salvat Announces the FDA Acceptance of NDA for its Cetraxal Otic Solution
• Sandoz Files Lawsuit Seeking FDA Ruling on Omnitrope
• Bayer and Onyx Announce FDA Acceptance of New Drug Application for Sorafenib for Individuals with Advanced Renal Cell Carcinoma

September 20, 2005

• FDA Extends PDUFA Date for Vivitrex to December 30, 2005
• Pfizer Receives FDA Non-Approvable Letter on Parecoxib

September 21, 2005

• BioSante Encouraged by FDA Panel on Exubera, Superior Results of Own Inhaled Insulin Study

September 22, 2005

• Further Update on Avanir's Neurodex New Drug Application

September 23, 2005

• AstraZeneca Submits New Drug Application (NDA) to FDA for Symbicort Maintenance Treatment of Asthma

September 26, 2005

• Ceragenix Submits 510(k) Application to FDA for Epiceram, a Skin Barrier Cream for Treatment of Eczema and Other Skin Disorders
• FDA Accepts for Filing a License Application for New Pediatric Combination Vaccine, Pentacel

September 27, 2005

• Insmed Receives Approvable Letter for iPlex

September 29, 2005

• Arranon Cancer Drug Receives Advisory Committee Support
• FDA Advisory Committee Votes Unanimously to Recommend Approval of Exjade for Once-Daily Oral Treatment of Chronic Iron Overload Due to Blood Transfusions
• NeoPharm Announces LEP-ETU Project Update

October 3, 2005

• Revlimid PDUFA Date Extended Three Months By FDA
• CollaGenex Pharmaceuticals' New Drug Application for Oracea Accepted for Review by FDA; Target PDUFA Date is May 30, 2006

October 4, 2005

• Valeant Pharmaceuticals Receives Approvable Letter from FDA Regarding Zelapar

October 11, 2005

• GlaxoSmithKline and POZEN Announce Trexima (Sumatriptan Succinate and Naproxen Sodium) New Drug Application Accepted for Review by FDA

October 12, 2005

• Barrier Therapeutics Submission for Zimycan Deemed a Complete Response by FDA

October 17, 2005

• Insmed Submits Response to FDA Approvable Letter for iPlex

October 18, 2005

• Bristol-Myers Squibb and Merck Joint Statement on Regulatory Status of Pargluva (Muraglitazar), an Investigational Oral Treatment for Type 2 Diabetes

October 19, 2005

• BioMarin Announces U.S. FDA Acceptance of Orapred ODT Filing

October 21, 2005

• Cephalon Receives Approvable Letter for Sparlon for the Treatment of ADHD in Children and Adolescents
• FDA Accepts Discovery Labs' Complete Response to Approvable Letter for Surfaxin

October 25, 2005

• FDA to Review Insmed's Complete Response to Approvable Letter for iPlex

October 26, 2005

• ALZA Corporation Receives Letter From FDA on Dapoxetine Application

October 27, 2005

• Bristol-Myers Squibb Statement on Muraglitazar, an Investigational Oral Treatment For Type 2 Diabetes
• Developmental Methylphenidate Patch Scheduled for FDA Advisory Committee Review

October 28, 2005

• Pfizer and sanofi-aventis Statement on Status of Exubera

November 1, 2005

• AstraZeneca Submits New Drug Application for Toprol-XL (metoprolol succinate)/Hydrochlorothiazide Combination Tablets for the Management of Hypertension

November 15, 2005

• DOR BioPharma Plans FDA NDA and European MAA Filing Strategy for orBec
• MGI PHARMA and SuperGen Provide Regulatory Status Updates for Dacogen (decitabine) Injection for MDS

November 16, 2005

• FDA Advisory Committee Recommends Additional Study Data to Support Approval of Certican in Heart Transplant Recipients

November 18, 2005

• Eisai Resubmits NDA for the Anti-epilepsy Drug Rufinamide

November 23, 2005

• FDA Issues Approvable Letter for Blood-Pool Contrast Agent Vasovist

November 24, 2005

• Shire Files Elaprase (idursulfase) With the FDA for the Treatment of Hunter Syndrome

November 28, 2005

• ALZA Corporation Resubmits U.S. New Drug Application for IONSYS (Fentanyl HCl Patient-Activated Transdermal System)

November 29, 2005

• Cilansetron; Solvay Pharmaceuticals Suspends Registration Activites in the U.S., While Discussions in Europe Continue

November 30, 2005

• New Drug Application Submitted for Paliperidone - a Potential New Treatment for Schizophrenia

December 1, 2005

• MediGene Announces FDA Acceptance of New Drug Application for Polyphenon E Ointment for the Treatment of Genital Warts

December 2, 2005

• Noven Announces Results of Daytrana Advisory Committee Meeting
• Inspire Announces Receipt of FDA Approvable Letter for Diquafosol

December 5, 2005

• Merck Submits Biologics License Application to FDA for Gardasil, the Company's Investigational Vaccine for Cervical Cancer

December 7, 2005

• Shire Announces New River Pharmaceuticals Filing of NRP104

December 9, 2005

• FDA Extends Review Period of New Drug Application for Oral Contraceptive Yaz to First Quarter 2006
• Barrier Therapeutics Announces FDA Acceptance of its New Drug Application for Sebazole Topical Gel

December 13, 2005

• Noven to Commence Manufacture of Daytrana Methylphenidate Transdermal System
• Sepracor Announces Submission of Arformoterol NDA to FDA for Chronic Obstructive Pulmonary Disease

December 14, 2005

• FDA Vaccines Advisory Committee Unanimously Agrees that Clinical Data from 70,000-Infant Phase III Trials Support the Efficacy and Safety of Rotateq, Merck's Investigational Vaccine for Rotavirus Gastroenteritis

December 15, 2005

• FDA Advisory Committee Agrees that Clinical Data Support the Efficacy and Safety of Zostavax, Merck's Investigational Vaccine for Shingles, in Adults Aged 60 and Older
• Dacogen (Decitabine) Injection Complete Response Accepted for Review By U.S. FDA
• GPC Biotech Begins Rolling NDA Submission for Lead Drug Candidate Satraplatin

December 22, 2005

• Endo Files Responses to FDA's Approvable Letters on NDAs for Oxymorphone ER and IR Tablets
• Shire Announces Filing of Mesavance (mesalamine) for Treatment of Ulcerative Colitis
• Wyeth Submits New Drug Application for Desvenlafaxine Extended Release (DVS-233) for Depression

December 23, 2005

• FDA Issues Approvable Letter for Daytrana Methylphenidate Transdermal System

December 26, 2005

• NDA for Immunosuppressant FK506 Modified Release Formulation Submitted in the US

December 27, 2005

• New Drug Application for Investigational HIV Protease Inhibitor TMC114 Submitted to U.S. Food & Drug Administration

December 28, 2005

• Bristol-Myers Squibb Submits New Drug Application for Dasatinib
• FDA Issues Approvable Letter for Vivitrol (formerly Vivitrex), for the Treatment of Alcohol Dependence

December 29, 2005

• Adolor Corporation Submits Investigational New Drug Application for Novel Delta Opioid Agonist Compound for the Management of Pain
• Genta Files New Drug Application for FDA Approval of Genasense Plus Chemotherapy for Patients with Advanced or Refractory Chronic Lymphocytic Leukemia

December 30, 2005

• Genentech Submits Biologics License Application for FDA Review of Lucentis in Wet Age-Related Macular Degeneration