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: 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
Company: Jerini AG
Treatment for: Angioedema
Icatibant is a selective B2 bradykinin receptor antagonist in development for the treatment of hereditary angioedema (HAE).
- Jerini to Submit Complete Response to the FDA for Icatibant in the Treatment of HAE - June 23, 2008
- FDA Issues Not Approvable Letter for Icatibant in the Treatment of HAE - April 24, 2008
- FDA Cancels Advisory Committee Meeting for Icatibant in the Treatment of HAE - Priority Review of Jerini's NDA Continues - January 8, 2008
- Jerini Receives NDA Filing Acceptance and Priority Review from the FDA for Icatibant in the Treatment of HAE - December 21, 2007
- Jerini Submits New Drug Application for Icatibant in the Treatment of HAE to the FDA and Requests Priority Review - October 31, 2007
- Jerini Initiates FDA Submission Process of New Drug Application for Icatibant in the Treatment of HAE - October 8, 2007
Company: GlaxoSmithKline
Treatment for: Idiopathic (Immune) Thrombocytopenic Purpura
Promacta (eltrombopag) is an investigational oral platelet growth factor therapy for the short-term treatment of previously treated patients with chronic idiopathic thrombocytopenic purpura (ITP) to increase platelet counts and reduce or prevent bleeding.
- Ligand Partner GlaxoSmithKline Receives FDA Extended Priority Review for Promacta NDA - June 23, 2008
- Promacta (eltrombopag) Receives Unanimous Recommendation by FDA Advisory Panel - May 30, 2008
- FDA Grants Priority Review for Promacta (eltrombopag) - March 3, 2008
- Ligand Earns $1 Million Milestone Payment as GlaxoSmithKline Submits New Drug Application for Promacta (eltrombopag) - December 21, 2007
- GlaxoSmithKline Files for FDA Approval of Promacta (eltrombopag) to be the First Oral Platelet Growth Factor for Rare Blood Disorder - December 20, 2007
Company: Merck & Co., Inc.
Treatment for: Hyperlipoproteinemia Type IIa (Elevated LDL), Hypertriglyceridemia
MK-0524A is an investigational compound containing extended-release niacin and laropiprant, a novel flushing pathway inhibitor designed to reduce flushing often associated with niacin treatment. MK-0524A is used either alone or with a statin, as adjunctive therapy to diet for the treatment of elevated LDL cholesterol, low HDL cholesterol and elevated triglyceride levels.
- Merck Provides Update on U.S. Regulatory Status of MK-0524A (ER niacin/laropiprant) and MK-0524B (ER niacin/laropiprant/simvastatin) - June 20, 2008
- Merck Receives Not Approvable Letter from FDA for MK-0524A (ER niacin/laropiprant) - April 29, 2008
- Merck Announces FDA Acceptance of NDA for Cordaptive (ER niacin/laropiprant), Formerly Known as MK-0524A, an Investigational Lipid-Modifier - August 29, 2007
Company: Discovery Laboratories, Inc.
Treatment for: Respiratory Distress Syndrome
Surfaxin, an engineered version of natural human lung surfactant, represents a potential alternative to the commercially available animal-derived surfactants used for the prevention of Respiratory Distress Syndrome in premature infants.
- Discovery Labs and FDA Meet to Clarify Limited Items in Surfaxin Approvable Letter - June 19, 2008
- Discovery Labs and FDA to Meet On June 18, 2008 to Clarify Limited Items in Surfaxin Approvable Letter - May 29, 2008
- Discovery Labs Provides Guidance On FDA Approvable Letter for Surfaxin for RDS - May 5, 2008
- Discovery Labs Receives An Approvable Letter From FDA for Surfaxin for RDS - May 2, 2008
- Discovery Labs' Response to Surfaxin Approvable Letter Deemed Complete by FDA - November 16, 2007
- Discovery Labs Submits Response to FDA Approvable Letter for Surfaxin for RDS in Premature Infants - November 1, 2007
- Surfaxin Process Validation Batches Achieve Stability Milestone to Enable Filing of Response to FDA Approvable Letter - October 1, 2007
- Discovery Labs Provides Update On Progress for Surfaxin for RDS - August 2, 2007
- Discovery Labs and FDA Reach Clarity On Path Towards Surfaxin RDS Approval - January 22, 2007
- Discovery Labs Updates Progress On Manufacturing Remediation and Surfaxin FDA Regulatory Matters - September 28, 2006
- Discovery Labs Receives Second Approvable Letter From FDA for Surfaxin for RDS - April 5, 2006
- FDA Accepts Discovery Labs' Complete Response to Approvable Letter for Surfaxin - October 21, 2005
- Discovery Labs Provides Update on Status of Response to FDA Approvable Letter for Surfaxin - August 19, 2005
- Discovery Labs Provides Status of Previously Submitted Response to FDA Approvable Letter for Surfaxin - August 15, 2005
- Discovery Labs Submits Response to FDA Approvable Letter for Surfaxin for RDS in Premature Infants - July 29, 2005
- Discovery Labs Receives Approvable Letter from FDA for Surfaxin for Respiratory Distress Syndrome in Premature Infants - February 14, 2005
- Discovery Laboratories Announces FDA Acceptance of Surfaxin New Drug Application - June 15, 2004
- Discovery Laboratories Files New Drug Application with the FDA to Market Surfaxin for the Prevention of Respiratory Distress Syndrome in Premature Infants - April 14, 2004
Company: Eurand Pharmaceuticals Ltd.
Treatment for: Exocrine Pancreatic Insufficiency
Zentase (pancrealipase) is a porcine-derived, pancreatic enzyme replacement product in development for the treatment of exocrine pancreatic insufficiency (EPI). In April, 2004, the FDA mandated that all manufacturers of EPI drug products file a NDA and receive approval for their products by April 2008 or be subject to regulatory action.
- Eurand Receives Approvable Letter From FDA for EUR-1008 (Zentase) - June 19, 2008
- Eurand Granted Priority Review for Zentase NDA - February 21, 2008
- Eurand Completes New Drug Application for Zentase - December 20, 2007
- Eurand Files NDA for Zentase for Exocrine Pancreatic Insufficiency - June 12, 2007
Company: Centocor, Inc.
Treatment for: Psoriasis
Ustekinumab is a new human monoclonal antibody in development for the treatment of moderate to severe plaque psoriasis.
- FDA Advisory Committee Unanimously Recommends Approval of Ustekinumab for Treatment of Moderate to Severe Plaque Psoriasis - June 18, 2008
- Centocor Announces Ustekinumab Biologic License Application Accepted for Filing by FDA - February 4, 2008
- Medarex to Receive Milestone Payment for Submission of Regulatory Applications Requesting Approval of Ustekinumab (CNTO 1275) for Treatment of Psoriasis - December 7, 2007
- Centocor and Janssen-Cilag Submit Applications Requesting Approval of Ustekinumab in the U.S. and Europe for Treatment of Moderate to Severe Plaque Psoriasis - December 4, 2007
Company: Genzyme Corporation
Treatment for: Stem Cell Mobilization
Mozobil is a small molecule CXCR4 chemokine receptor antagonist which enhances mobilization of hematopoietic stem cells for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma.
More...New Drug Applications Archive
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