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.
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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.
- Extreme Weather in Washington D.C. has Postponed the FDA's Oncologic Drugs Advisory Committee Meeting Scheduled for 10 February 2010 - February 9, 2010
- ChemGenex Pharmaceuticals Announces Omapro to be Reviewed by the FDA's Oncologic Drugs Advisory Committee for the Treatment of Adults with Chronic Myeloid Leukemia who have Failed Prior Therapy with Imatinib and have the Bcr-Abl T315I Mutation - December 17, 2009
- 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: Cell Therapeutics, Inc.
Treatment for: non-Hodgkin's Lymphoma
Pixantrone (BBR 2778) is a novel major groove binder with an aza-anthracenedione molecular structure in development to treat relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL).
- FDA Postpones Oncologic Drugs Advisory Committee Meeting to Review Pixantrone Due to Severe Weather Conditions - February 9, 2010
- Cell Therapeutics Announces FDA's Oncologic Drugs Advisory Committee to Review Pixantrone for the Treatment of Relapsed/Refractory Aggressive Non-Hodgkin's Lymphoma, February 10, 2010 - December 17, 2009
- FDA Sets Action Date of April 23, 2010 for Review of Pixantrone NDA - September 6, 2009
- FDA Accepts to File Cell Therapeutics' New Drug Application for Pixantrone - August 26, 2009
- Cell Therapeutics Completes Pixantrone NDA Submission and Requests Priority Review - June 24, 2009
- Cell Therapeutics Initiating Rolling NDA Submission For Pixantrone - April 14, 2009
Company: Chelsea Therapeutics International, Ltd.
Treatment for: Hypotension
Northera (droxidopa) is an orally active synthetic precursor of norepinephrine in development for the treatment of neurogenic orthostatic hypotension.
Company: Repros Therapeutics Inc.
Treatment for: Hypogonadism -- Male
Androxal (enclomiphene) is a non-steroidal estrogen receptor antagonist under development for the treatment of men of reproductive age with low testosterone levels who want to improve or maintain their fertility and/or sperm function while being treated for low testosterone.
Company: GlaxoSmithKline and XenoPort, Inc.
Treatment for: Restless Legs Syndrome
Horizant (gabapentin enacarbil) is a new chemical entity designed to improve upon the pharmacokinetics of gabapentin. Horizant is in development for the once-daily treatment of moderate-to-severe primary Restless Legs Syndrome.
- XenoPort Announces Horizant as Brand Name for XP13512 - February 4, 2010
- XenoPort to Receive $23 Million in Milestone Payments Associated With FDA Acceptance of Solzira NDA - March 16, 2009
- GSK and XenoPort Resubmit New Drug Application for Solzira in Restless Legs Syndrome - January 9, 2009
- GSK and XenoPort Announce Plans to Withdraw and Resubmit New Drug Application Requesting Approval of Solzira for Restless Legs Syndrome - November 10, 2008
- GSK and XenoPort Announce Submission of NDA Requesting FDA Approval of Solzira for Restless Legs Syndrome - September 16, 2008
Company: Lux Biosciences, Inc.
Treatment for: Uveitis
Luveniq (voclosporin) a next-generation calcineurin inhibitor in development for the treatment of noninfectious uveitis involving the intermediate or posterior segments of the eye.
Company: Javelin Pharmaceuticals, Inc.
Treatment for: Pain
Dyloject (diclofenac sodium injection) is an IV non-steroidal anti-inflammatory drug (NSAID) in development for the management of acute moderate-to-severe pain in adults.
Company: Teva Pharmaceutical Industries Ltd.
Treatment for: Neutropenia Associated with Chemotherapy
XM02 is a granulocyte colony-stimulating factor (G-CSF) in development for the reduction in the duration of severe neutropenia and the incidence of febrile neutropenia in patients treated with established myelosuppressive chemotherapy for cancer.
Company: Protalix BioTherapeutics, Inc.
Treatment for: Gaucher Disease
Uplyso (taliglucerase alfa) is a plant-cell expressed recombinant form of glucocerebrosidase in development for the treatment of Gaucher disease.
Company: Sepracor Inc.
Treatment for: Epilepsy, Seizures
Stedesa (eslicarbazepine acetate) is a voltage-gated sodium channel blocker in development as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy.
- FDA Extends PDUFA Action Date for Stedesa New Drug Application - January 29, 2010
- Sepracor's Stedesa (eslicarbazepine acetate) New Drug Application Formally Accepted for Review by the FDA - June 1, 2009
- Sepracor Announces Submission of Stedesa New Drug Application to FDA for Adjunctive Treatment of Epilepsy - March 31, 2009
Company: Warner Chilcott Limited
Treatment for: Contraception
WC 3016 is a low dose oral contraceptive in development for birth control.
Company: Somaxon Pharmaceuticals
Treatment for: Insomnia
Silenor is a low-dose oral tablet formulation of doxepin hydrochloride being developed for use in insomnia. Doxepin has been prescribed at higher dosages for more than 35 years for the treatment of depression and anxiety.
- Somaxon Provides Update on New Drug Application for Silenor for the Treatment of Insomnia - January 25, 2010
- Somaxon Scheduled to Meet with FDA to Discuss Complete Response Letter for Silenor NDA - December 18, 2009
- Somaxon Receives Complete Response Letter from the FDA for Silenor NDA - December 7, 2009
- Somaxon Announces $6 Million Private Equity Financing and Acceptance of NDA Resubmission of Silenor for the Treatment of Insomnia - July 7, 2009
- Somaxon Resubmits New Drug Application for Silenor (Doxepin) for the Treatment of Insomnia - June 5, 2009
- Somaxon Provides Update on New Drug Application for Silenor (doxepin) for the Treatment of Insomnia - April 7, 2009
- Somaxon Receives Complete Response Letter from the FDA for Silenor (doxepin) - February 27, 2009
- FDA Extends Review of Somaxon Pharmaceuticals' New Drug Application for Silenor (Doxepin) by up to Three Months - November 24, 2008
- Somaxon Pharmaceuticals Announces Acceptance for Filing of New Drug Application for Silenor for the Treatment of Insomnia - April 15, 2008
- Somaxon Pharmaceuticals Submits New Drug Application for Silenor for the Treatment of Insomnia - January 31, 2008
- Somaxon Pharmaceuticals Provides Update on Silenor Development Program - May 9, 2007
- Somaxon Pharmaceuticals’ Silenor Demonstrates Positive Results in its Third Phase 3 Clinical Trial in Insomnia - November 20, 2006
Company: Genzyme Corporation
Treatment for: Pompe disease
Lumizyme (alglucosidase alfa) is under review for the treatment of Pompe disease.
- Genzyme's Lumizyme BLA Receives Six-Month FDA Review - January 21, 2010
- Genzyme to Reopen Enrollment in Alglucosidase Alfa Temporary Access Program - December 7, 2009
- 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: MannKind Corporation
Treatment for: Diabetes Mellitus Type I, Diabetes Mellitus Type II
Afrezza (insulin human [rDNA origin]) Inhalation Powder is an ultra rapid-acting insulin for oral inhalation in development for the treatment of adults with type 1 or type 2 diabetes mellitus for the control of hyperglycemia.
- MannKind Updates Status of Afrezza New Drug Application - January 13, 2010
- Emisphere Technologies Receives Milestone Payment from MannKind Corporation - May 21, 2009
- MannKind Submits NDA for Afresa for Treatment of Diabetes - March 16, 2009
Company: MAP Pharmaceuticals, Inc.
Treatment for: Migraine
Levadex (dihydroergotamine) is an investigational orally inhaled migraine therapy.
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).
Company: ADVENTRX Pharmaceuticals, Inc.
Treatment for: Non-Small Cell Lung Cancer
ANX-530 is a proprietary emulsion formulation of vinorelbine (available as Navelbine) intended to reduce the incidence and severity of vein irritation associated with intravenous delivery of the drug. ANX-530 is under review for the treatment of non-small cell lung cancer.
- ADVENTRX Pharmaceuticals Submits ANX-530 New Drug Application - January 6, 2010
Company: Dainippon Sumitomo Pharma America, Inc.
Treatment for: Schizophrenia
Lurasidone is an investigational atypical antipsychotic agent for the treatment of schizophrenia.
Company: Biodel, Inc.
Treatment for: Diabetes Mellitus Type I, Diabetes Mellitus Type II
VIAject is a modified form of recombinant human insulin is designed to be absorbed into the blood faster than currently marketed rapid-acting insulin analogs. VIAject is under review as a treatment for diabetes.
Company: Wyeth Pharmaceuticals
Treatment for: Pneumococcal Disease Prophylaxis
Prevnar 13, Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM(197) is a vaccine designed to protect against the 13 most prevalent serotypes associated with pneumococcal disease (PD).
- Pfizer Provides U.S. Regulatory Update On Prevnar 13 Vaccine - January 5, 2010
- Wyeth Provides Regulatory Update on Prevnar 13 in the United States - August 12, 2009
- Wyeth Submits Marketing Application to FDA for its 13-Valent Vaccine for the Prevention of Pneumococcal Disease in Infants and Toddlers - March 31, 2009
See also: Generic Approvals, New Drug Approvals, Recent Additions to Drugs.com, Alphabetical Listing of all New Drug Applications, FDA Approval Process
New Drug Applications Archive
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