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: 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
Company: Fibrocell Science, Inc.
Treatment for: Facial Wrinkles
Laviv (azfibrocel-T) is an autologous cell therapy being investigated for the treatment of moderate to severe nasolabial fold wrinkles in adults.
- Fibrocell Science, Inc. Reports Outcome of FDA Advisory Committee Meeting on Azfibrocel-T for Wrinkles - October 12, 2009
Company: Orexo AB
Treatment for: Pain
Abstral (fentanyl) is a fast-dissolving sublingual tablet formulation in development for the management of breakthrough cancer pain in patients who are already receiving opioid analgesics.
- Orexo confirms FDA acceptance of Abstral filing - October 6, 2009
- Abstral NDA submitted to the FDA for approval in the USA - August 6, 2009
Company: GlaxoSmithKline
Treatment for: Renal Cell Carcinoma
Votrient (pazopanib) is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma.
- FDA Approves GlaxoSmithKline’s Votrient for Advanced Renal Cell Cancer - October 19, 2009
- GlaxoSmithKline Receives Unanimous FDA Panel Approval Recommendation for Votrient - October 5, 2009
Company: Merck Serono
Treatment for: Multiple Sclerosis
Cladribine Tablets is an investigational oral formulation of cladribine under review as a therapy for reducing relapses in people with relapsing forms of multiple sclerosis (MS).
- Merck Submits Application for Cladribine Tablets as a Potential Oral Short-Course Multiple Sclerosis Therapy in the United States - October 2, 2009
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 Establish Path for Potential Surfaxin Approval - October 2, 2009
- Discovery Labs and FDA to Meet On September 29, 2009 to Discuss Potential Path for Surfaxin Approval - September 11, 2009
- Discovery Labs Reports On Surfaxin End of Review Meeting With FDA - July 2, 2009
- Discovery Labs and FDA to Meet On June 2, 2009 to Discuss Surfaxin Complete Response Letter - May 12, 2009
- FDA Establishes Target Action Date of April 17, 2009 for Potential Approval of Discovery Labs' Surfaxin - November 10, 2008
- Discovery Labs Submits Complete Response to May 2008 FDA Approvable Letter for Surfaxin for RDS - October 20, 2008
- Discovery Labs Reports Technical Achievements Towards Gaining FDA Approval of Surfaxin - September 24, 2008
- Discovery Labs Reports Progress in Responding to Surfaxin FDA Approvable Letter - August 6, 2008
- 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: Sciele Pharma, Inc. and Addrenex Pharmaceuticals
Treatment for: Attention Deficit Disorder
Clonicel is a modified-release clonidine formulation in development to treat attention deficit hyperactivity disorder (ADHD).
- Sciele Pharma and Addrenex Announce Submission of sNDA to FDA for Clonicel to Treat ADHD - October 2, 2009
Company: Sciele Pharma, Inc.
Treatment for: Pediatric Drooling
Glycopyrrolate oral solution is an anticholinergic formulation in development to treat chronic, moderate-to-severe drooling in pediatric patients. This condition often results from cerebral palsy as well as from other neurological disorders.
- Sciele Pharma Submits New Drug Application to FDA for Glycopyrrolate Oral Solution, a Treatment for Chronic, Moderate-to-Severe Drooling in Pediatric Patients - September 29, 2009
New Drug Applications Archive
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