New Drug Applications Archive for 2004

January 1, 2004

• Aventis Submits New Drug Application to FDA for Asthma Drug Alvesco (ciclesonide)

January 14, 2004

• Andrx Receives FDA Approvable Letter for its Valproate NDA

January 15, 2004

• New Drug Application Submitted for Once-Daily Allegra-D (fexofenadine HCl 180 mg/pseudoephedrine HCl 240 mg) Formulation Using aaiPharma's Development Expertise

January 21, 2004

• Micrologix Meets with FDA on MBI-226

January 22, 2004

• Vicuron Pharmaceuticals Announces 90-Day Extension of FDA Review of Anidulafungin New Drug Application

January 28, 2004

• Pfizer Submits Supplemental New Drug Application Requesting Changes in Geodon Product Label
• SuperGen completes submission of New Drug Application (NDA) for Orathecin as an oral treatment for pancreatic cancer
• Alcon Files NDA for Combination Drug to Treat Glaucoma; Releases PreliminaryClinical Data at Major Ophthalmology Meeting

January 30, 2004

• Inspire Pharmaceuticals Announces Outcome of Meeting with the FDA on Diquafosol

February 2, 2004

• Mylan Laboratories and Watson Pharmaceuticals Announce Receipt of "Approvable" Letter for Emsam
• Yamanouchi Pharma America Submits New Drug Application to the FDA for Conivaptan Hydrochloride to treat Hyponatremia
• Mylan Laboratories and Watson Pharmaceuticals Announce Receipt of “Approvable” Letter for Emsam

February 3, 2004

• FDA Accepts Allos New Drug Application with Priority Review for RSR13 in Brain Metastases from Breast Cancer

February 4, 2004

• FDA Approves Alimta for use with cisplatin, for the treatment of Malignant Pleural Mesothelioma

February 6, 2004

• Aventis and Genta Announce FDA Acceptance and Priority Review of New Drug Application for Genasense in Advanced Melanoma
• Aventis' Dermik Laboratories Announces FDA Acceptance of Filing For Sculptra to Treat Facial Lipoatrophy
• Review of ISTA Pharmaceuticals' New Drug Application for Vitrase for Use as a Spreading Agent Extended 90 Days by FDA

February 17, 2004

• La Jolla Pharmaceutical’s New Drug Application for Lupus Drug Candidate Riquent Accepted for Review by FDA

February 18, 2004

• Biogen Idec and Elan Announce Intention to Submit for Approval for Multiple Sclerosis Based on One-Year Data

February 19, 2004

• Access’ OraDisc A NDA Accepted For Filing

February 23, 2004

• FDA Accepts Pharmion's New Drug Application for Filing and Grants Priority Review for Vidaza for the Treatment of Myelodysplastic Syndromes (MDS)
• Eligard - Atrix Submits New Drug Application to FDA for First of Its Kind Six-Month Prostate Cancer Product

March 1, 2004

• Sepracor Announces Approvable Action for Estorra (eszopiclone) for the Treatment of Insomnia and Provides Update on Launch Plans

March 2, 2004

• H3 Pharma Inc. Submits New Drug Application To FDA for Sanvar IR

March 4, 2004

• Connetics' New Drug Application for Actiza Has Been Accepted For Filing by the FDA

March 8, 2004

• American Pharmaceutical Partners and American BioScience Announce Filing of a New Drug Application for FDA Approval of Abraxane for the Treatment of Metastatic Breast Cancer

March 9, 2004

• Oxypurinol Regulatory Filing Accepted for Review

March 12, 2004

• Allos NDA To Be Reviewed By FDA Advisory Committee

March 15, 2004

• Gilead Submits Applications to U.S. and European Regulatory Authorities for Fixed Dose Co-Formulation of Viread and Emtriva
• INEX and Enzon Complete the Filing of a New Drug Application for Onco TCS

March 26, 2004

• Sculptra From Dermik Laboratories Receives Recommendation For Approval With Conditions From FDA Advisory Panel
• SuperGen’s New Drug Application for Orathecin (rubitecan) capsules accepted by FDA for filing
• SuperGen’s New Drug Application for Orathecin (rubitecan) capsules accepted by FDA for filing

March 31, 2004

• ILEX Completes New Drug Application for Clofarabine; Filing Offers Hope to Children with Most Difficult-to-Treat Leukemias
• Miravant Submits New Drug Application For SnET2-PDT to Treat Macular Degeneration

April 8, 2004

• Connetics' New Drug Application for Extina Has Been Accepted for Filing by the FDA

April 14, 2004

• Discovery Laboratories Files New Drug Application with the FDA to Market Surfaxin for the Prevention of Respiratory Distress Syndrome in Premature Infants

April 20, 2004

• Genta and Aventis Announce Genasense Expanded Access Program for Patients with Advanced Melanoma

April 22, 2004

• SuperGen Announces FDA Acceptance of Rolling NDA Request for Dacogen

April 27, 2004

• Fujisawa Healthcare, Inc. Submits NDA For Mycamine For Treatment Of Esophageal Candidiasis

April 28, 2004

• Biovail and Depomed Submit NDA for Glumetza; Submission Includes 500mg and 1000mg dosages; Biovail/Depomed Expand Royalty Agreement to Include 1000mg dose

April 29, 2004

• FDA Accepts for Filing Santarus' New Drug Application for Rapinex Powder for Oral Suspension 40mg

May 3, 2004

• FDA Advisory Committee Reviews Genasense For Use in Advanced Melanoma

May 4, 2004

• FDA Advisory Committee Does Not Recommend Approval of RSR13 as Adjunctive Therapy for the Treatment of Brain Metastases Originating From Breast Cancer

May 5, 2004

• Mylan Submits New Drug Application for Nebivolol

May 7, 2004

• Adolor Submits First Portion of NDA for Entereg

May 10, 2004

• American Pharmaceutical Partners and American BioScience Announce FDA Acceptance of New Drug Application of Abraxane for the Treatment of Metastatic Breast Cancer

May 13, 2004

• Genta Announces Withdrawal of New Drug Application for Genasense in Melanoma

May 17, 2004

• U.S. FDA Grants Priority Review to Gilead's Fixed Dose Co-Formulation of Viread and Emtriva for HIV

May 21, 2004

• INEX and Enzon Announce FDA Acceptance of Onco TCS New Drug Application

May 24, 2004

• Vicuron Pharmaceuticals Receives Approvable Letter from FDA for Anidulafungin for the Treatment of Esophageal Candidiasis Requesting Additional Data

May 25, 2004

• ISTA Pharmaceuticals Announces Submission of Xibrom NDA to the FDA
• Biogen Idec and Elan Submit Biologics License Application to the FDA for Approval of Antegren for Multiple Sclerosis Based on One-Year Data

May 26, 2004

• FDA Announces Advisory Committee Meeting Date for Macugen (pegaptanib sodium injection)

June 1, 2004

• Adolor Submits Second Portion of NDA for Entereg
• SuperGen Submits CMC to FDA as First Component of Rolling New Drug Application for Dacogen
• Miravant's SnET2 New Drug Application Accepted for Filing by FDA with Priority Review Designation

June 2, 2004

• Allos Therapeutics Receives FDA Approvable Letter for RSR13 (efaproxiral)

June 3, 2004

• FDA Begins Priority Review of ILEX NDA for Clofarabine in Pediatric Acute Leukemia; Filing Acceptance Indicates Start of Official Review Period

June 15, 2004

• Discovery Laboratories Announces FDA Acceptance of Surfaxin New Drug Application

June 16, 2004

• Sepracor Announces Resubmission of Estorra NDA to FDA
• Allos Therapeutics Announces New Trade Names for Efaproxiral in the U.S. and Europe

June 17, 2004

• U.S. New Drug Application Approval Expected for Metvix
• Eyetech/Pfizer File New Drug Application for Macugen (pegaptanib sodium injection), the First Investigational Anti-VEGF Therapy for Wet Age-Related Macular Degeneration

June 21, 2004

• NovaDel Pharma files for US FDA approval of Nitroglycerin Lingual Spray, its first product

June 24, 2004

• Amgen Submits Biologics License Application for FDA Approval of Palifermin
• FDA Extends Action Date for Cymbalta for Continued Analysis of Already-Submitted Data
• Cardiome Receives FDA Approvable Letter on Oxypurinol for Gout
• Biovail, Depomed Announce Glumetza NDA Accepted by FDA

June 28, 2004

• Elan Files Amendment to New Drug Application for Prialt for Severe Chronic Pain Based on Additional Efficacy and Safety Data
• Adolor Completes Submission of NDA for Entereg

June 29, 2004

• OSI Pharmaceuticals Announces That Tarceva Has Been Accepted into the FDA's Pilot 1 Program

June 30, 2004

• New Drug Application for Exenatide Submitted to FDA for Type 2 Diabetes
• Cellegy Submits NDA for Cellegesic to Treat Chronic Anal Fissure Pain
• Alcon Updates Filing Status of Retaane New Drug Application

July 1, 2004

• Solvay Pharmaceuticals, Inc. Submits New Drug Application to the United States Food and Drug Administration for Cilansetron toTreat Irritable Bowel Syndrome with Diarrhea Predominance in Men and Women
• Mylan's NDA for Nebivolol Accepted for FDA Review
• CoTherix, Inc. Announces Filing of Ventavis NDA

July 5, 2004

• Teva Receives Approvable Letter for Agilect (rasagiline)

July 7, 2004

• GlaxoSmithKline Submits Biologics License Application for FDA Approval of Boostrix

July 13, 2004

• Schering-Plough Reports Posaconazole NDA Accepted for FDA Review

July 15, 2004

• Sepracor Announces FDA Acceptance of Estorra NDA Resubmission and Issuance of Class 2 Review Designation

July 20, 2004

• Fosrenol: FDA Action Date Extended, US Launch Target Unaffected

July 21, 2004

• FDA Will Grant ILEX's Clofarabine Additional Six-Month Pediatric Exclusivity; Incentive Provides Extended Patent Protection Upon Marketing Approval

July 26, 2004

• FDA Accepts ISTA Pharmaceuticals' New Drug Application for Xibrom
• FDA Accepts Biologics License Application for Antegren for Multiple Sclerosis

July 27, 2004

• ALZA Corporation Receives Approvable Letter Regarding IONSYS, an Iontophoretic, Fentanyl-containing, Transdermal Analgesic

August 2, 2004

• OSI Pharmaceuticals and Genentech Announce Completion of New Drug Application for FDA Approval of Tarceva
• Allergan Receives Approvable Letter for Lumigan Timolol Combination

August 3, 2004

• DVC Announces FDA Acceptance for Filing of Vaccinia Immune Globulin BLA

August 9, 2004

• FDA Issues Approvable Letter to Bausch & Lomb for Ophthalmic Anti-inflammatory/Antibiotic Combination Product

August 11, 2004

• Aventis Submits Application for FDA Licensure of Adacel Vaccine for Prevention of Tetanus, Diphtheria and Pertussis in Adolescents and Adults

August 18, 2004

• Eyetech/Pfizer Announce FDA Acceptance of the New Drug Application for Macugen (pegaptanib sodium injection)

August 24, 2004

• ILEX Updates Clofarabine NDA with Encouraging Results; Additional Patient Data Resets FDA Action Date

August 27, 2004

• FDA Advisory Committee Reviews Clinical Data of Eyetech/Pfizer Priority 1 NDA Submission for Macugen, an Investigational Treatment for Neovascular AMD

August 30, 2004

• FDA Issues 'Approvable Letter' for Certican

September 1, 2004

• NDA for Cellegesic is Accepted for Review by FDA
• Cilansetron NDA Filing Accepted for Priority Review by the FDA for the Treatment of Irritable Bowel Syndrome with Diarrhea Predominance
• Atrix and Fujisawa Submit New Drug Application for Acne Product
• Exenatide New Drug Application Accepted for Review by the FDA

September 2, 2004

• FDA Defers Decision on Omnitrope Application
• Pfizer Statement on Regulatory Status of Lyrica

September 8, 2004

• CoTherix, Inc. Announces Priority Review Designation by the FDA for Ventavis NDA
• FDA Accepts Entereg for Review

September 9, 2004

• Bonefos Accepted for Filing and Granted Priority Review by FDA

September 10, 2004

• FDA Advisory Committee Recommends Further Data to Support Approval of AstraZeneca's Oral Anticoagulant Exanta

September 15, 2004

• FDA Issues Approvable Letter to Berlex Laboratories for Angeliq

September 17, 2004

• Alcon Receives Approvable Letter for Extravan

September 20, 2004

• Depomed Announces Proquin XR NDA Accepted by FDA

September 21, 2004

• Vicuron Pharmaceuticals Provides Update on Anidulafungin Regulatory Paths

September 22, 2004

• Advisory Panel Recommends FDA Licensure of Aventis' Menactra Vaccine for Protection Against Meningococcal Disease

September 24, 2004

• Takeda Submits New Drug Application for Ramelteon, an Investigational Sleep Drug

September 27, 2004

• INEX and Enzon Announce Marqibo to be Reviewed by FDA's Oncologic Drugs Advisory Committee

September 28, 2004

• ILEX's Clofarabine Scheduled For FDA Advisory Committee Review; ODAC to Review Pivotal Data for Pediatric Acute Leukemia

September 29, 2004

• Schwarz Pharma Submits Marketing Applications for its Rotigotine Patch 'Neupro'
• NovaDel NDA for Nitroglycerin Lingual Spray is Accepted for Review by FDA

September 30, 2004

• Amylin Pharmaceuticals Submits Complete Response to FDA for Symlin
• OSI Pharmaceuticals Announces Acceptance of Tarceva New Drug Application for Review by the U.S. Food and Drug Administration

October 4, 2004

• Bristol-Myers Squibb Submits Applications in U.S. and Europe to Market Entecavir, an Investigational Antiviral Treatment For Chronic Hepatitis B Infection

October 8, 2004

• AstraZeneca Receives Action Letter From FDA for Exanta (ximelagatran)

October 14, 2004

• La Jolla Pharmaceutical Company Receives Letter From FDA About Riquent
• Cellegesic Granted Priority Review by FDA
• Chiron Submits New Drug Application for Pulminiq; Inhaled Form of Cyclosporine Could Be First Immunosuppressant Indicated for Chronic Lung-Transplant Rejection

October 19, 2004

• Neurocrine Submits New Drug Application (NDA) for Indiplon Immediate Release Capsules for the Treatment of Insomnia

October 25, 2004

• Boehringer Ingelheim Submits New Drug Application to U.S. Food and Drug Administration for Tipranavir
• Connetics' New Drug Application for Velac Has Been Accepted for Filing by the FDA

October 26, 2004

• Aventis Receives Approvable Letter from U.S. Food and Drug Administration for Alvesco (ciclesonide) for Treatment of Persistent Asthma

October 29, 2004

• Merck Receives ’Approvable’ Letter for Arcoxia
• Takeda Submits New Drug Application for Combination Type 2 Diabetes Medication, Actoplus Met (pioglitazone HCl and metformin HCl)

November 1, 2004

• SuperGen and MGI Pharma Announce Submission of Dacogen NDA to US FDA
• Nastech Receives FDA Approvable Letter for Nascobal Nasal Spray

November 2, 2004

• Forest Laboratories Updates Lercanidipine Development

November 3, 2004

• Akzo Nobel’s Contraceptive Implanon Receives “Approvable” Status from the FDA

November 4, 2004

• Merck Files Biologics License Application for Proquad With U.S. Food and Drug Administration

November 18, 2004

• Berlex Receives Approvable Letter From FDA on the Company's Second Oral Contraceptive Containing Drospirenone

November 22, 2004

• Neurocrine Submits New Drug Application (NDA) for Indiplon Modified Release Tablets for the Treatment of Insomnia

November 24, 2004

• Connetics Receives FDA Non-Approvable Letter for Extina

November 29, 2004

• BioMarin Submits U.S. Biologics License Application for Marketing Authorization of Aryplase for MPS VI
• Barrier Therapeutics Submits Amendment to NDA for U.S. Regulatory Approval of Zimycan
• SuperGen Announces 90 Day Extension of FDA Review Date for Orathecin New Drug Application

December 1, 2004

• FDA Issues Approvable Letter for Yamanouchi's Investigational Hyponatremia Treatment Conivaptan Hydrochloride Injection
• FDA Advisory Committee Recommends Accelerated Clofarabine Approval for Most Common Pediatric Leukemia; FDA to Make Approval Decision by End of Year
• INEX and ENZON Announce ODAC Does Not Support Accelerated Approval for Cancer Drug Marqibo

December 3, 2004

• Pfizer Submits Regulatory Filings for Revatio as a Treatment for Pulmonary Arterial Hypertension
• BioSante Pharmaceuticals Comments on FDA Advisory Committee's Decision Not to Recommend Approval of Testosterone Patch

December 4, 2004

• New Drug Application Submitted for Dapoxetine for Premature Ejaculation

December 14, 2004

• Abbott Submits New Drug Application to U.S. FDA for Advanced Prostate Cancer Drug, Xinlay (atrasentan)

December 15, 2004

• Chiron Receives FDA Priority Review Designation for New Drug Application for Pulminiq -- Cyclosporine, USP-- Inhalation Solution
• Wyeth Seeks Global Regulatory Approval of Tygacil (Tigecycline) for Injection
• TAP Submits New Drug Application for Febuxostat for the Management of Hyperuricemia in Chronic Gout

December 16, 2004

• Alcon Submits Retaane - Drug Applications to U.S. and European Regulatory Authorities
• AVANIR Announces Submission of Rolling NDA With Priority Review for Neurodex

December 20, 2004

• Solvay Pharmaceuticals, Inc. Announces 90-Day Extension of FDA Review of the New Drug Application for Cilansetron for the Treatment of Irritable Bowel Syndrome with Diarrhea Predominance (IBS-D)

December 21, 2004

• Indiplon IR NDA (New Drug Application) to Be Reformatted Due to Difficulties in Accessing Portions of the Electronic NDA
• POZEN's MT 100 To Be Reviewed by Advisory Committee in May 2005
• Cephalon Files Application for Marketing Approval of New Modafinil Formulation for the Treatment of Children and Adolescents with Attention-Deficit/Hyperactivity Disorder
• Vicuron Pharmaceuticals Submits New Drug Application for Dalbavancin to U.S. Food and Drug Administration

December 22, 2004

• Duramed's Seasonique NDA Accepted for Filing by FDA

December 23, 2004

• Bristol-Myers Squibb Provides Regulatory Update for Muraglitazar
• Bristol-Myers Squibb Provides Regulatory Update for Abatacept
• NitroMed Submits BiDil New Drug Application Amendment; Company Prepares for Commercialization of First Heart Failure Treatment for African Americans
• FDA Issues Not Approvable Letter for Cellegesic