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 the FDA's How Drugs are Developed and Approved page.
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
Company: AstraZeneca
Treatment for: Acute Coronary Syndrome
Brilinta (ticagrelor) is an investigational oral antiplatelet treatment for the reduction of major adverse cardiac events in patients with acute coronary syndrome (ACS).
- AstraZeneca Submits US New Drug Application for ticagrelor (Brilinta), an Investigational Antiplatelet Agent - November 19, 2009
Company: NicOx S.A.
Treatment for: Osteoarthritis
Naproxcinod is the first in a new class of anti-inflammatory agents known as CINODs (Cyclooxygenase-Inhibiting Nitric Oxide Donators) in development for the relief of the signs and symptoms of osteoarthritis.
- NicOx announces FDA accepts naproxcinod NDA for filing - November 18, 2009
- NicOx submits New Drug Application (NDA) for naproxcinod to the US FDA - September 25, 2009
Company: Genzyme Corporation
Treatment for: Pompe disease
Lumizyme (alglucosidase alfa) is under review for the treatment of Pompe disease.
- Genzyme Receives Complete Response Letter on Lumizyme Application - November 17, 2009
- Genzyme Submits All Information Requested by FDA for Lumizyme - May 21, 2009
- Genzyme Receives Complete Response Letter from FDA on Lumizyme Application - March 3, 2009
Company: Covidien
Treatment for: Pain
Exalgo (hydromorphone) is an investigational once-a-day extended release opioid formulation for relief for of moderate to severe pain in opioid tolerant patients.
- Neuromed Receives FDA Feedback on New Drug Application for Exalgo Extended-Release Tablets - November 16, 2009
- FDA Advisory Committee Hears Presentations and Public Comment on Exalgo Extended-Release Tablets - September 23, 2009
Company: Human Genome Sciences, Inc.
Treatment for: Anthrax
ABthrax (raxibacumab) is a human monoclonal antibody drug in development for the treatment of inhalation anthrax.
- Human Genome Sciences Receives Complete Response Letter from FDA for Raxibacumab Biologics License Application - November 16, 2009
- Human Genome Sciences Submits Biologics License Application to FDA for ABthrax - May 21, 2009
Company: Cadence Pharmaceuticals, Inc.
Treatment for: Pain, Fever
Acetavance (intravenous acetaminophen) is an investigational product for the treatment of acute pain and fever in adults and children.
- Cadence Pharmaceuticals Announces FDA Extends New Drug Application Review for Intravenous Acetaminophen by Three Months - November 13, 2009
- Cadence Pharmaceuticals Announces Priority Review and Acceptance of NDA Submission for Acetavance for Treatment of Acute Pain and Fever - July 15, 2009
- Cadence Pharmaceuticals Submits Acetavance New Drug Application for the Treatment of Acute Pain and Fever - May 13, 2009
Company: ChemGenex Pharmaceuticals
Treatment for: Chronic Myelogenous Leukemia
Omapro (omacetaxine mepesuccinate) is a first-in-class small molecule drug in development for the treatment of imatinib-resistant chronic myeloid leukemia (CML) patients with the T315I mutation.
- ChemGenex Announces FDA Accepts NDA for Omapro (Omacetaxine Mepesuccinate) and Grants the Filing Priority Review Status - November 10, 2009
- ChemGenex Submits New Drug Application for Omapro (omacetaxine Mepesuccinate) to U.S. FDA - September 9, 2009
- 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: Theratechnologies
Treatment for: HIV-Associated Lipodystrophy
Tesamorelin is an analogue of the growth hormone releasing factor proposed for the treatment of excess abdominal fat in HIV patients with lipodystrophy.
- Theratechnologies' NDA for Tesamorelin to be Reviewed by an FDA Advisory Committee - November 5, 2009
- U.S. Food And Drug Administration Has Accepted To File Theratechnologies' New Drug Application for tesamorelin - August 12, 2009
- Theratechnologies Files a New Drug Application for Tesamorelin With the US Food and Drug Administration - June 3, 2009
Company: InterMune, Inc.
Treatment for: Idiopathic Pulmonary Fibrosis
Pirfenidone is an orally active small molecule drug that may inhibit collagen synthesis, down regulate production of multiple cytokines and block fibroblast proliferation and stimulation in response to cytokines. Pirfenidone is in development for the treatment of patients with idiopathic pulmonary fibrosis (IPF).
- InterMune Announces Submission of NDA for Pirfenidone for the Treatment of Patients with IPF - November 4, 2009
Company: Shire plc
Treatment for: Gaucher Disease
Velaglucerase alfa is an enzyme replacement therapy in development for the treatment of Gaucher Disease.
- FDA Grants Priority Review for Shire's velaglucerase alfa for Type 1 Gaucher Disease - November 4, 2009
- Shire Completes Submission of NDA for Velaglucerase Alfa for Type 1 Gaucher Disease and Reports Positive Results for Remaining Two Phase III Trials - September 2, 2009
- Shire has Filed a Treatment Protocol for Velaglucerase Alfa for Gaucher Disease - July 7, 2009
Company: GTx, Inc.
Treatment for: Prevention of Fractures
Toremifene is an oral selective estrogen receptor modulator in development for the prevention of bone fractures in men with prostate cancer on androgen deprivation therapy.
- GTx Receives Complete Response Letter from FDA for Toremifene 80 mg New Drug Application - November 2, 2009
- FDA Provides PDUFA Target Agency Action Date For GTx's Toremifene 80 mg NDA - March 5, 2009
- GTx Announces Toremifene 80 mg NDA Accepted for Review by FDA - February 18, 2009
- GTx Submits New Drug Application for Toremifene 80 mg for the Prevention of Bone Fractures in Men with Prostate Cancer on Androgen Deprivation Therapy - December 30, 2008
Company: Dendreon Corporation
Treatment for: Prostate Cancer
Provenge (sipuleucel-T) is an investigational active cellular immunotherapy (ACI) in late-stage clinical development for the treatment of patients with metastatic castrate-resistant prostate cancer.
- Dendreon Completes Submission of Biologics License Application for Provenge - November 2, 2009
- D.C. Denies Prostate Cancer Vaccine, Provenge: Dendreon (WA) Not FDA To Blame - July 30, 2007
- Prostate Cancer Patients, Survivors and Advocates Assemble on Capitol Hill to Rally against FDA's Non Approval of Provenge - June 1, 2007
- Dendreon Announces FDA Confirms Data Required for Provenge Licensure - May 31, 2007
- Dendreon Receives Complete Response Letter From FDA for Provenge Biologics License Application - May 9, 2007
- Dendreon Announces FDA Advisory Committee Reviewed Provenge for Hormone Refractory Prostate Cancer - March 30, 2007
- Dendreon to Hold Post Advisory Committee Conference Call for Provenge - March 27, 2007
- Dendreon Announces FDA's Cellular, Tissue and Gene Therapies Advisory Committee to Review Provenge for the Treatment of Asymptomatic, Metastatic, Androgen-Independent Prostate Cancer - March 1, 2007
- Dendreon’s Provenge Granted FDA Priority Review - January 16, 2007
- Dendreon Completes Submission of Biologics License Application to FDA for Provenge in Hormone Refractory Prostate Cancer - November 13, 2006
- Dendreon Submits Clinical and Non-Clinical Sections of Rolling BLA to FDA for Provenge - August 24, 2006
- Dendreon Announces Plans to Submit BLA - September 14, 2005
Company: Transcept Pharmaceuticals, Inc.
Treatment for: Insomnia
Intermezzo is a low dose, buffered, sublingual formulation of zolpidem intended to be the first prescription sleep aid to be indicated for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep.
- Transcept Pharmaceuticals Receives Complete Response Letter from FDA on Intermezzo New Drug Application - October 30, 2009
- Transcept Pharmaceuticals Announces Expected FDA Extension of Regulatory Review Period for Intermezzo - June 11, 2009
- Transcept Pharmaceuticals Announces FDA Acceptance for Review of New Drug Application for Intermezzo - December 16, 2008
- Transcept Pharmaceuticals Submits New Drug Application for Intermezzo for Treatment of Middle-of-the-Night Awakenings - October 1, 2008
Company: Gilead Sciences, Inc.
Treatment for: Pneumonia with Cystic Fibrosis
Aztreonam lysine for inhalation is an investigational therapy in development for people with cystic fibrosis (CF) who have pulmonary Pseudomonas aeruginosa infection.
- Gilead's Aztreonam for Inhalation Solution to be Reviewed by FDA Anti-Infective Drugs Advisory Committee on December 10, 2009 - October 26, 2009
- Gilead Receives Response From U.S. FDA on Company's Request for Formal Dispute Resolution for Aztreonam for Inhalation Solution - February 19, 2009
- Gilead Receives Complete Response Letter from U.S. Food and Drug Administration for Aztreonam Lysine for Inhalation, an Investigational Treatment for Cystic Fibrosis - September 17, 2008
- PARI's eFlow Included in Gilead's NDA Submission for Aztreonam Lysine for Inhalation - November 26, 2007
- Gilead Submits New Drug Application to U.S. FDA for Aztreonam Lysine for Inhalation for Cystic Fibrosis - November 16, 2007
Company: Novartis
Treatment for: Chronic Obstructive Pulmonary Disease
QAB149 (indacaterol) is an investigational once-daily bronchodilator for the treatment of adult patients with chronic obstructive pulmonary disease (COPD).
- Novartis receives Complete Response letter from FDA for QAB149, an investigational bronchodilator for COPD - October 23, 2009
Company: Endo Pharmaceuticals
Treatment for: Hypogonadism -- Male
Fortesta (testosterone) is a transdermal gel formulation under review for testosterone replacement therapy in male hypogonadism.
- Endo Pharmaceuticals Gives Update on Regulatory Status of Fortesta - October 22, 2009
- Endo Pharmaceuticals to Partner With ProStrakan to Commercialize Fortesta in the U.S. - August 26, 2009
Company: Acorda Therapeutics, Inc.
Treatment for: Multiple Sclerosis
Fampridine-SR (4-aminopyridine) is an investigational drug being developed to improve walking ability in people with multiple sclerosis.
- Acorda Therapeutics Announces Extension of Fampridine-SR PDUFA Goal Date to January 22, 2010 - October 22, 2009
- Acorda Therapeutics Announces Positive Vote by FDA Advisory Committee for Fampridine-SR - October 14, 2009
- Acorda Therapeutics Reports Date of FDA Advisory Committee Review of Fampridine-SR for Improvement of Walking Ability in People with MS - August 25, 2009
- Acorda Therapeutics Announces FDA Acceptance of Fampridine-SR New Drug Application for Filing - May 6, 2009
- Acorda Therapeutics Resubmits New Drug Application for Fampridine-SR for Improvement of Walking Ability in People with Multiple Sclerosis - April 23, 2009
- Acorda Therapeutics Receives Refuse to File Letter from FDA on Fampridine-SR NDA - March 31, 2009
- Acorda Therapeutics Submits NDA for Fampridine-SR for Improvement of Walking Ability in People with Multiple Sclerosis - February 2, 2009
Company: Amgen Inc.
Treatment for: Prevention of Osteoporosis, Osteoporosis
Prolia (denosumab) is an investigational RANK Ligand inhibitor for the treatment and prevention of postmenopausal osteoporosis (PMO) in women, and treatment and prevention of bone loss in patients undergoing hormone ablation for either prostate or breast cancer.
- Amgen Provides Update on Status of Prolia (denosumab) Biologics License Application (BLA) Submitted to the U.S. Food and Drug Administration (FDA) - October 21, 2009
- Amgen Issues Statement on Outcomes of Advisory Committee for Reproductive Health Drugs (ACRHD) Meeting - August 14, 2009
- FDA Accepts Amgen's Submission and Files Biologics License Application for Denosumab - February 18, 2009
- Amgen Submits Biologics License Application for FDA Approval of Denosumab in Women With Postmenopausal Osteoporosis and in Patients Undergoing Hormone Ablation for Either Prostate or Breast Cancer - December 22, 2008
Company: King Pharmaceuticals, Inc.
Treatment for: Diagnostic
CorVue (binodenoson) is an investigational cardiac pharmacologic stress SPECT (single-photon-emission computed tomographic) imaging agent intended for use in patients with or at risk for coronary artery disease (CAD) who are unable to perform a cardiac exercise stress test.
- FDA Issues Complete Response Letter for CorVue - October 21, 2009
- King Pharmaceuticals Announces Submission of New Drug Application for CorVue - December 19, 2008
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New Drug Applications Archive
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