New Drug Applications
See also: Generic Approvals, New Drug Approvals, Recent Additions to Drugs.com, Alphabetical Listing of all New Drug Applications, FDA Approval Process
Latest New Drug Applications
The New Drug Application (NDA) is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the United States.
The purpose of a NDA is to provide enough information to permit the FDA to reach the following key decisions:
- Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks.
- Whether the drug's proposed labeling (package insert) is appropriate, and what it should contain.
- Whether the methods used in manufacturing the drug and the controls used to maintain the drug's quality are adequate to preserve the drug's identity, strength, quality, and purity.
For more information on New Drug Applications, please visit http://www.fda.gov/cder/regulatory/applications/NDA.htm
Company: Bristol-Myers Squibb Company and AstraZeneca
Treatment for: Diabetes Mellitus Type II
Onglyza (saxagliptin) is an investigational DPP-4 inhibitor for the treatment of type 2 diabetes.
Company: NexMed, Inc.
Treatment for: Erectile Dysfunction
Alprox-TD is a topically applied alprostadil cream in development for the treatment of erectile dysfunction.
- NexMed Receives FDA Response for Topical ED Product - July 23, 2008
- NexMed Confirms FDA Acceptance of NDA for Erectle Dysfunction Product - November 20, 2007
- NexMed Files NDA for Proprietary Erectile Dysfunction Treatment - September 24, 2007
Company: Xanodyne Pharmaceuticals, Inc.
Treatment for: Pain
Zipsor is a rapid release diclofenac potassium formulation in development for the treatment of patients with mild to moderate acute pain.
Company: Summers Laboratories
Treatment for: Lice
Summers’ Lice Asphyxiator is a non-toxic, insecticide-free head lice treatment awaiting FDA approval. This product contains a naturally occurring monohydric aralkyl alcohol, which prevents lice from closing their spiracles (sophisticated breathing apparatus) thereby asphyxiating the lice within ten minutes.
- Sciele Pharma Announces That the FDA Has Issued an Approvable Letter for the Head Lice Treatment - July 16, 2008
- Sciele Provides Update on Head Lice Asphyxiation Product - February 20, 2008
- Sciele Pharma Announces FDA Acceptance of NDA for Summers Laboratories' Head Lice Treatment - August 16, 2007
Company: Amgen Inc.
Treatment for: Thrombocytopenia Idiopathic, Idiopathic (Immune) Thrombocytopenic Purpura
Nplate (romiplostim) is a thrombopoietin mimetic peptibody in development for the treatment of thrombocytopenia in adult patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP).
- Amgen's FDA Nplate Approval Statement Retracted - July 15, 2008
- FDA Approves Nplate for Long-Term Treatment of Adult Chronic ITP - July 14, 2008
- Amgen Statement on Successful Outcome of Romiplostim Panel Meeting - March 13, 2008
- Amgen to Discuss Romiplostim Application at FDA ODAC Meeting - March 12, 2008
Company: Genta Incorporated
Treatment for: Chronic Lymphocytic Leukemia
Genasense (oblimersen sodium) inhibits production of Bcl-2, a protein made by cancer cells that is thought to block chemotherapy-induced apoptosis (programmed cell death). By reducing the amount of Bcl-2 in cancer cells, Genasense may enhance the effectiveness of current anticancer treatment. Genasense is being evaluated for use in the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL).
- FDA Accepts Genta's NDA Amendment as Complete Response for Genasense Treatment of Chronic Lymphocytic Leukemia - July 14, 2008
- Genta Submits NDA Amendment to FDA for Genasense as Treatment of Chronic Lymphocytic Leukemia - June 6, 2008
- FDA Indicates That Genasense Approval in Chronic Lymphocytic Leukemia Will Require Additional Confirmatory Data - March 17, 2008
- FDA Extends Review of Genasense NDA Appeal in Chronic Lymphocytic Leukemia - January 14, 2008
- Genta Completes Appeal of FDA Decision for Genasense in CLL - October 25, 2007
- Genta Appeals FDA Decision on Genasense in CLL - April 4, 2007
- Genta Announces the Company Will Appeal FDA Action on New Drug Application of Genasense in Chronic Lymphocytic Leukemia - February 6, 2007
- Genta Receives Non-Approvable Notice for Application of Genasense in Patients With Chronic Lymphocytic Leukemia - December 15, 2006
- FDA Extends Review Period for Genasense New Drug Application in Chronic Lymphocytic Leukemia - October 30, 2006
- Briefing Documents Posted for FDA Committee Review of Genasense New Drug Application - September 5, 2006
- Genta Announces FDA's Oncology Drug Advisory Committee Will Review Genasense as Treatment for Chronic Lymphocytic Leukemia - July 27, 2006
- Genasense New Drug Application Accepted for Review by FDA - March 1, 2006
- Genta Files New Drug Application for FDA Approval of Genasense Plus Chemotherapy for Patients with Advanced or Refractory Chronic Lymphocytic Leukemia - December 29, 2005
- Genta Initiates New Drug Application for Genasense in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia - June 30, 2005
- Genta Announces Withdrawal of New Drug Application for Genasense in Melanoma - May 13, 2004
- FDA Advisory Committee Reviews Genasense For Use in Advanced Melanoma - May 3, 2004
- Genta and Aventis Announce Genasense Expanded Access Program for Patients with Advanced Melanoma - April 20, 2004
- Aventis and Genta Announce FDA Acceptance and Priority Review of New Drug Application for Genasense in Advanced Melanoma - February 6, 2004
Company: Digestive Care, Inc.
Treatment for: Pancreatic Exocrine Dysfunction
Pancrecarb is a pancreatic enzyme replacement therapy for the treatment of Exocrine Pancreatic Insufficiency. In April 2004, the FDA determined that prescription Exocrine Pancreatic Insufficiency drug products are medically necessary and, accordingly, allowed the drug manufacturers four years (April 2008) to obtain approved new drug applications.
- Digestive Care, Inc. Announces the Filing of the First Module of NDA Submission for Pancrecarb (pancrelipase) - July 7, 2008
Company: VioQuest Pharmaceuticals
Xyfid (1% uracil topical) is a topical skin preparation in development for the treatment of dry skin conditions and to manage the burning and itching associated with various dermatoses.
- VioQuest Pharmaceuticals Submits 510(k) Application to FDA for Xyfid, a Novel Topical Agent for the Treatment of Various Skin Disorders - July 1, 2008
Company: ChemGenex Pharmaceuticals
Treatment for: Chronic Myelogenous Leukemia
Omacetaxine mepesuccinate, a first-in-class small molecule which induces apoptosis by inhibition of protein synthesis is a new drug in development for the treatment of imatinib-resistant chronic myeloid leukemia (CML) patients with the T315I mutation.
- ChemGenex Announces Submission of Non-Clinical Section of Rolling NDA for Omacetaxine - July 1, 2008
- ChemGenex appoints VP Regulatory Affairs - Confirms Planned NDA Rolling Submission for Omacetaxine Following Meeting with U.S. FDA - April 14, 2008
Company: Alpharma Inc.
Treatment for: Pain
Embeda is an abuse-deterrent, extended-release morphine preparation in development for the treatment of chronic pain.
- Alpharma Announces the Resubmission of a New Drug Application for Embeda Capsules - July 1, 2008
- Alpharma to Withdraw and Resubmit Its New Drug Application for Embeda - April 22, 2008
- Alpharma Submits New Drug Application for Embeda - February 29, 2008
Company: Schering AG and EPIX Pharmaceuticals, Inc.
Treatment for: Diagnosis of Vascular Disease
- EPIX Pharmaceuticals Announces Resubmission of New Drug Application for Vasovist - July 1, 2008
- EPIX Provides Update Regarding Status of Vasovist Appeal - April 2, 2007
- Epix Pharmaceuticals Files Formal Appeal for Vasovist with the Center for Drug Evaluation and Research - February 28, 2007
- Epix Pharmaceuticals to File Appeal with the Center for Drug Evaluation and Research for Vasovist - December 14, 2006
- Epix Pharmaceuticals Receives Response from the FDA Regarding Appeal of Vasovist Approvable Letters - August 28, 2006
- FDA Extends Review of EPIX Pharmaceuticals’ Appeal of Vasovist Approvable Letters - July 28, 2006
- EPIX Pharmaceuticals Files Appeal with FDA Regarding Vasovist Approvable Letters - June 30, 2006
- FDA Issues Approvable Letter for Blood-Pool Contrast Agent Vasovist - November 23, 2005
- EPIX Submits Response to FDA Approvable Letter - May 23, 2005
- FDA has completed its review of the NDA for MS-325 - January 14, 2005
Company: Acusphere Inc.
Treatment for: Detection of Coronary Artery Disease
Imagify is an investigational new drug developed to assess perfusion using ultrasound (or echocardiography) for the detection of coronary artery disease.
- Acusphere Announces FDA Acceptance of Imagify NDA for Detection of Coronary Artery Disease - June 30, 2008
- Acusphere Submits New Drug Application for FDA Approval of Imagify - April 29, 2008
Company: Indevus Pharmaceuticals, Inc.
Treatment for: Hypogonadism -- Male
Nebido is a long-acting depot preparation of testosterone undecanoate, developed for the treatment of male hypogonadism. Nebido is expected to be the first three-month testosterone preparation available in the U.S.
- Indevus Receives Approvable Letter from FDA for Nebido - June 30, 2008
- Indevus Pharmaceuticals Provides Update on Nebido NDA Status - June 4, 2008
- FDA Accepts New Drug Application for Nebido Submitted by Indevus - November 1, 2007
- Indevus Announces Submission of New Drug Application for Nebido - August 28, 2007
Company: GlaxoSmithKline
Treatment for: Human Papillomavirus Prophylaxis
Cervarix (human papillomavirus vaccine, AS04 adjuvant-adsorbed) is a preventative cervical cancer vaccine.
- GlaxoSmithKline Responds to FDA on Cervarix and Plans to Submit Final Study Data for Approval - June 30, 2008
- GlaxoSmithKline Receives FDA 'Complete Response' Letter for Cervarix Cervical Cancer Vaccine - December 17, 2007
- GlaxoSmithKline Submits Biologics License Application to U.S. Food and Drug Administration for Cervarix - March 29, 2007
Company: Introgen Therapeutics, Inc.
Treatment for: Head and Neck Cancer
Advexin is a targeted molecular therapy in phase 3 clinical trials for the treatment of head and neck cancer.
- Introgen Submits Advexin Regulatory Applications in the U.S. and Europe - June 30, 2008
- Introgen Plans to Expand Biomarker Database in Phase 3 Trials and File BLA and MAA for Advexin in Advanced Head and Neck Cancer in First Half of 2008 - December 20, 2007
Company: Schering-Plough/Merck Pharmaceuticals
Treatment for: Allergic Rhinitis
This medicine is a single tablet that contains the active ingredients of Claritin (loratadine) and Singulair (montelukast sodium), both of which are indicated for the relief of symptoms of allergic rhinitis.
- Schering-Plough and Merck Announce Withdrawal of Loratadine/Montelukast NDA and Termination of Respiratory Joint Venture - June 27, 2008
- Schering-Plough/Merck Pharmaceuticals Receives Not-Approvable Letter from FDA for Loratadine/Montelukast - April 28, 2008
- Schering-Plough/Merck Pharmaceuticals Announce FDA Filing Acceptance of New Drug Application for Loratadine/Montelukast Tablet - August 28, 2007
Company: Centocor, Inc.
Treatment for: Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis
Golimumab is a human anti-tumor necrosis factor (TNF)-alpha monoclonal antibody currently in development for the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.
- Centocor, Inc. Submits BLA to FDA for Golimumab in the Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis - June 27, 2008
Company: Otsuka Pharmaceutical Development & Commercialization, Inc.
Treatment for: Hyponatremia
Tolvaptan is an investigational selective V2-vasopressin receptor antagonist for the treatment of adults with worsening heart failure and the treatment of hyponatremia.
- U.S. Food and Drug Administration Advisory Committee Recommends Approval of Tolvaptan, an Investigational Treatment for Hyponatremia - June 26, 2008
- New Drug Application for Tolvaptan, Otsuka's Investigational Novel Oral Treatment for Worsening Heart Failure and Hyponatremia, Accepted by the U.S. Food and Drug Administration - December 21, 2007
Company: Daiichi Sankyo Company, Limited and Eli Lilly and Company
Treatment for: Acute Coronary Syndrome
Effient (prasugrel) is an oral antiplatelet agent in development for the treatment of patients with acute coronary syndrome (ACS) who are managed with percutaneous coronary intervention including coronary stenting.
- FDA Extends Review Period for Daiichi Sankyo, Lilly Investigative Antiplatelet Drug, Prasugrel - June 24, 2008
- FDA Grants Priority Review for Daiichi Sankyo, Lilly Drug, Prasugrel - February 22, 2008
- Daiichi Sankyo, Lilly Submit New Drug Application for Investigational Antiplatelet Drug, Prasugrel, with U.S. Food and Drug Administration - January 4, 2008
New Drug Applications Archive
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