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
January 7, 2005
January 10, 2005
January 11, 2005
January 14, 2005
January 18, 2005
January 19, 2005
January 24, 2005
January 28, 2005
- Schwarz Pharma Re-Submits NDA for Rotigotine in the U.S.
- FDA Grants Tygacil (Tigecycline) NDA Priority Review Status
February 1, 2005
February 3, 2005
February 7, 2005
- Neurocrine Biosciences Announces Resubmission Status of Indiplon
- NPS Provides Update on Preos NDA Process and Timing
February 11, 2005
February 14, 2005
February 24, 2005
February 25, 2005
February 28, 2005
March 1, 2005
March 2, 2005
March 3, 2005
March 9, 2005
March 10, 2005
March 11, 2005
March 14, 2005
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
March 28, 2005
March 31, 2005
April 1, 2005
- FDA Requests Further Data on Cilansetron, Solvay's Proposed Treatment for Irritable Bowel Syndrome with Diarrhea Predominance (IBS-D)
- Alkermes Announces Submission of New Drug Application for Vivitrex for Treatment of Alcohol Dependence
- Sucampo Submits New Drug Application for Lubiprostone, an Investigational Compound for the Treatment of Chronic Idiopathic Constipation
April 8, 2005
April 11, 2005
April 13, 2005
April 14, 2005
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
April 26, 2005
April 28, 2005
April 29, 2005
May 2, 2005
- BDSI Announces Submission of NDA for Emezine; First Transmucosal Product for the Treatment of Nausea and Vomiting
- Merck Submits Biologics License Application to FDA for Zostavax, an Investigational Vaccine for Shingles and Shingles-Associated Nerve Pain
- FDA Accepts Tercica's Increlex New Drug Application With Priority Review for the Treatment of Short Stature
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
May 8, 2005
May 11, 2005
- Vicuron Pharmaceuticals Announces Extension of FDA Review of Dalbavancin New Drug Application
- Further Trial Data Awaited for Bonefos in the U.S.
May 19, 2005
May 23, 2005
May 24, 2005
May 25, 2005
- GlaxoSmithKline Submits Biologics License Application for FDA Approval of Fluarix
- Encysive Pharmaceuticals Submits New Drug Application for Thelin
- Barrier Therapeutics Receives Not Approvable Letter From the FDA for Zimycan
May 26, 2005
- Neurocrine Announces Submission of New Drug Application for Indiplon Tablets
- Halozyme Therapeutics Announces FDA Acceptance of Hylenex NDA
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
June 1, 2005
- Inspire Submits Amendment to New Drug Application for Diquafosol for the Treatment of Dry Eye
- Allergan Receives Written Response from FDA on Oral Tazarotene
- 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
June 10, 2005
- SALVAT Files NDA for its Cetraxal Otic - Ciprofloxacin Otic- 0.2% Solution, for the Treatment of External Otitis
- FDA Extends PDUFA Date for SomatoKine to October 3, 2005
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
June 15, 2005
June 16, 2005
- Somerset Files Response to Emsam Action Letter
- FDA Advisory Committee Recommends Approval for NitroMed's BiDil to Treat Black Patients With Heart Failure
June 17, 2005
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
June 23, 2005
June 28, 2005
June 29, 2005
- FDA Sets August 4, 2005 for Advisory Committee Meeting to Consider Tardive Dyskinesia Risk with MT 100
- Penwest Receives Non-Approvable Letter from FDA for PW2101
- 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
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
- Genta Initiates New Drug Application for Genasense in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia
- Avanir Submits NDA for Neurodex
- Cellegy Reports Status of Response Date for FDA Review
- 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
July 15, 2005
July 18, 2005
July 20, 2005
July 22, 2005
July 26, 2005
- Neurocrine Announces Acceptance of New Drug Application for Indiplon Tablets
- Shire and Noven Resubmitted NDA for MTS, a Candidate Treatment for Pediatric ADHD Patients
- InKine Announces the Acceptance for Filing of Its New Drug Application (NDA) for Its Next Generation Purgative Product -- INKP-102
- Santarus Announces FDA Acceptance of New Drug Application For Zegerid Chewable Tablets
July 27, 2005
- Wyeth's New Drug Application for New Oral Contraceptive With Uninterrupted Dosing Regimen Accepted for Filing at FDA
- CV Therapeutics Submits Amendment to Ranexa (ranolazine)
- 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
August 5, 2005
August 8, 2005
August 10, 2005
August 14, 2005
August 15, 2005
August 17, 2005
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
August 22, 2005
August 24, 2005
August 29, 2005
August 30, 2005
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
September 9, 2005
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
- Salvat Announces the FDA Acceptance of NDA for its Cetraxal Otic Solution
- Sandoz Files Lawsuit Seeking FDA Ruling on Omnitrope
- FDA Advisory Committee Recommends Accelerated Approval of GlaxoSmithKline's Arranon (nelarabine) Injection
- FDA Oncologic Drugs Advisory Committee Recommends Revlimid for Full Approval
- Bayer and Onyx Announce FDA Acceptance of New Drug Application for Sorafenib for Individuals with Advanced Renal Cell Carcinoma
September 20, 2005
- Pfizer Receives FDA Non-Approvable Letter on Parecoxib
- FDA Extends PDUFA Date for Vivitrex to December 30, 2005
September 21, 2005
September 22, 2005
September 23, 2005
September 26, 2005
- FDA Accepts for Filing a License Application for New Pediatric Combination Vaccine, Pentacel
- Ceragenix Submits 510(k) Application to FDA for Epiceram, a Skin Barrier Cream for Treatment of Eczema and Other Skin Disorders
September 27, 2005
September 29, 2005
- FDA Advisory Committee Votes Unanimously to Recommend Approval of Exjade for Once-Daily Oral Treatment of Chronic Iron Overload Due to Blood Transfusions
- Arranon Cancer Drug Receives Advisory Committee Support
- 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
October 11, 2005
October 12, 2005
October 17, 2005
October 18, 2005
October 19, 2005
October 21, 2005
- FDA Accepts Discovery Labs' Complete Response to Approvable Letter for Surfaxin
- Cephalon Receives Approvable Letter for Sparlon for the Treatment of ADHD in Children and Adolescents
October 25, 2005
October 26, 2005
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
November 1, 2005
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
November 18, 2005
November 23, 2005
November 24, 2005
November 28, 2005
November 29, 2005
November 30, 2005
December 1, 2005
December 2, 2005
- Noven Announces Results of Daytrana Advisory Committee Meeting
- Inspire Announces Receipt of FDA Approvable Letter for Diquafosol
December 5, 2005
December 7, 2005
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
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
- GPC Biotech Begins Rolling NDA Submission for Lead Drug Candidate Satraplatin
- Dacogen (Decitabine) Injection Complete Response Accepted for Review By U.S. FDA
December 22, 2005
- Wyeth Submits New Drug Application for Desvenlafaxine Extended Release (DVS-233) for Depression
- Shire Announces Filing of Mesavance (mesalamine) for Treatment of Ulcerative Colitis
- Endo Files Responses to FDA's Approvable Letters on NDAs for Oxymorphone ER and IR Tablets
December 23, 2005
December 26, 2005
December 27, 2005
December 28, 2005
- FDA Issues Approvable Letter for Vivitrol (formerly Vivitrex), for the Treatment of Alcohol Dependence
- Bristol-Myers Squibb Submits New Drug Application for Dasatinib
December 29, 2005
- Genta Files New Drug Application for FDA Approval of Genasense Plus Chemotherapy for Patients with Advanced or Refractory Chronic Lymphocytic Leukemia
- Adolor Corporation Submits Investigational New Drug Application for Novel Delta Opioid Agonist Compound for the Management of Pain
December 30, 2005
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.