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
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: Acura Pharmaceuticals, Inc.
Treatment for: Pain
Acurox (oxycodone hydrochloride and niacin) is an oral immediate release narcotic analgesic in development for the relief of moderate to severe pain. Acurox is designed to deter common methods of opioid misuse and abuse.
- Acura and King Receive FDA Complete Response Letter Regarding Acurox - July 2, 2009
- Acurox Tablets New Drug Application Accepted for Filing With a Priority Review Classification - March 3, 2009
- New Drug Application Submitted For Acurox Tablets - January 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 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: PhotoCure ASA
Treatment for: Diagnostic
Hexvix (hexaminolevulinate) is a diagnostic agent in development for the detection of papillary bladder cancer using fluorescence cystoscopy.
- Photocure submits application for marketing approval for Hexvix in USA to the FDA - July 1, 2009
- FDA Requests More Information Related to Hexvix NDA - April 20, 2006
Company: Novartis Vaccines and Diagnostics
Treatment for: Meningitis -- Meningococcal
Menveo (MenACWY-CRM) is an investigational vaccine for the prevention of meningococcal disease.
- Novartis Receives Complete Response Letter From The US Food And Drug Administration For Its Investigational Vaccine Menveo - July 1, 2009
Company: Pozen Inc. and AstraZeneca
Treatment for: Osteoarthritis, Rheumatoid Arthritis, Ankylosing Spondylitis
Vimovo (formerly PN 400) is an investigational compound that combines the pain reliever naproxen (an NSAID) with esomeprazole magnesium (a proton pump inhibitor) for the treatment of the signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in patients who are at risk of developing gastric ulcers.
- Pozen Submits New Drug Application For Vimovo (PN 400) - June 30, 2009
- Pozen Receives Decision from AstraZeneca to File PN 400 NDA - May 13, 2009
Company: ISTA Pharmaceuticals, Inc.
Treatment for: Allergic Conjunctivitis
Bepreve (bepotastine ophthalmic solution) is an antihistamine and mast cell stabilizer in development for treatment of the symptoms of allergic conjunctivitis.
- Dermatologic and Ophthalmic Drugs Advisory Committee Unanimously Recommends Bepreve for the Treatment of Ocular Itching Associated with Allergic Conjunctivitis - June 28, 2009
- ISTA Pharmaceuticals Announces FDA Advisory Committee to Review Bepreve for the Treatment of Ocular Itching Associated with Allergic Conjunctivitis - June 2, 2009
- ISTA Pharmaceuticals' New Drug Application for Bepreve Accepted for Review by U.S. Food and Drug Administration - January 15, 2009
- ISTA Pharmaceuticals Files New Drug Application with U.S. FDA for Bepreve - November 14, 2008
Company: Takeda Pharmaceutical Company Limited
Treatment for: Diabetes Mellitus Type II
Alogliptin is a highly selective dipeptidyl peptidase-4 (DPP-4) inhibitor under investigation for the treatment of type 2 diabetes.
- Takeda Receives FDA Complete Response Letter for Alogliptin, an Investigational Treatment for Type 2 Diabetes - June 28, 2009
- Takeda Receives New Information on Alogliptin (SYR-322) NDA - March 6, 2009
- Takeda Receives New Action Date for Alogliptin (SYR-322) NDA - December 24, 2008
- FDA Continues Review of Takeda's New Drug Application for Alogliptin (SYR-322), a DPP-4 Agent for Type 2 Diabetes - October 10, 2008
- PPD Confirms Takeda's NDA Filing of Alogliptin with U.S. Food and Drug Administration - February 29, 2008
- Takeda Submits New Drug Application for Alogliptin (SYR-322) in the U.S. - January 4, 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).
- 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: Savient Pharmaceuticals, Inc.
Treatment for: Gout
Krystexxa (pegloticase) is a bio-uricolytic agent in late-stage development for treatment-failure gout to control hyperuricemia and to manage the signs and symptoms of gout.
- FDA Appointed Arthritis Advisory Committee Recommends U.S. Food and Drug Administration Approval for Krystexxa for Refractory Chronic Gout - June 17, 2009
- Savient Announces New Date for FDA Arthritis Advisory Panel Review of Krystexxa for Treatment Failure Gout - May 7, 2009
- Savient Provides Update on Pegloticase BLA - February 12, 2009
- Savient Announces FDA's Advisory Panel to Review Pegloticase for Treatment-Failure Gout Patients - January 28, 2009
- Pegloticase BLA Filing Accepted for Priority Review by FDA - December 30, 2008
- Savient Submits Biologics License Application (BLA) for Pegloticase - October 31, 2008
Company: BioAlliance Pharma SA
Treatment for: Oropharyngeal Candidiasis
Loramyc (miconazole) mucoadhesive buccal tablet is an antifungal therapy currently in development for the treatment of oropharyngeal candidiasis, an opportunistic infection commonly found in immunocompromised patients, including those with HIV and cancer.
- Bioalliance Pharma Submits Loramyc NDA to US FDA And Announces a General Shareholders' Meeting to Amend Its By-Laws - June 16, 2009
- Bioalliance Pharma to Resubmit Loramyc NDA in the Second Quarter of 2009 - May 7, 2009
- Bioalliance Pharma To Complete NDA For Loramyc With Data on Debossed Mucoadhesive Tablet - April 9, 2009
Company: GlaxoSmithKline and Genmab A/S
Treatment for: Chronic Lymphocytic Leukemia, non-Hodgkin's Lymphoma, Rheumatoid Arthritis, Multiple Sclerosis
Arzerra (ofatumumab) is an investigational monoclonal antibody being developed to treat chronic lymphocytic leukemia, non-Hodgkin's lymphoma, diffuse large B-cell lymphoma, rheumatoid arthritis and relapsing-remitting multiple sclerosis.
- FDA Extends Review of Arzerra (ofatumumab) - June 16, 2009
- GSK/Genmab Receive Favorable Recommendation for Arzerra from FDA Advisory Panel - May 29, 2009
- FDA Advisory Committee to Review Arzerra (Ofatumumab) - May 4, 2009
- Arzerra (Ofatumumab) Granted Priority Review By FDA - April 3, 2009
- GlaxoSmithKline and Genmab Submit Arzerra (Ofatumumab) Application to FDA for the Treatment of Advanced Stage Blood Cancer - January 30, 2009
Company: BioDelivery Sciences International, Inc.
Treatment for: Pain
Onsolis is a small, dissolvable, polymer disc, formulated with the opioid narcotic fentanyl for application to the buccal (inner lining of cheek) membranes. Onsolis is in development for the management of breakthrough cancer pain in opioid tolerant patients.
- BioDelivery Sciences Provides NDA Update for Onsolis - June 15, 2009
- BioDelivery Sciences Submits REMS for Onsolis to FDA for Approval - December 15, 2008
- BioDelivery Sciences to Meet with FDA to Finalize Proposed REMS for Onsolis - November 7, 2008
- BioDelivery Sciences Anticipates First Half 2009 Approval of BEMA Fentanyl (Onsolis) - August 28, 2008
- FDA Accepts for Filing the BEMA Fentanyl NDA from BioDelivery Sciences - January 10, 2008
- BioDelivery Sciences Submits NDA For BEMA Fentanyl - October 31, 2007
Company: Orphan Therapeutics, LLC and Ikaria Holdings, Inc.
Treatment for: Hepatorenal Syndrome
Lucassin (terlipressin) is a synthetic vasopressin analogue in development for the treatment of hepatorenal syndrome (HRS) Type 1.
- FDA Accepts Final Section of NDA Filing for Lucassin - June 12, 2009
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 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: NeurogesX, Inc.
Treatment for: Postherpetic Neuralgia
Qutenza, formerly NGX-4010, is a capsaicin transdermal patch being developed for the management of pain due to postherpetic neuralgia.
- NeurogesX Provides U.S. Regulatory Update for Qutenza - June 10, 2009
- NeurogesX Announces FDA Acceptance to Review New Drug Application for NGX-4010 to Treat Post-Herpetic Neuralgia - December 19, 2008
- NeurogesX Submits NDA for NGX-4010 Dermal Capsaicin Patch for Treatment of Postherpetic Neuralgia (PHN) - October 22, 2008
Company: SkyePharma PLC
Treatment for: Asthma
Flutiform metered dose inhaler is a fixed-dose combination of formoterol (a long-acting beta-agonist) and fluticasone (a corticosteroid), being developed for the treatment of asthma.
- SkyePharma PLC - Flutiform U.S. Filing Update - June 10, 2009
- Skyepharma plc: Flutiform NDA Accepted for Review - May 22, 2009
- SkyePharma PLC - Flutiform Progress Update - August 6, 2007
Company: Dyax Corp.
Treatment for: Angioedema
DX-88 (ecallantide) is a recombinant small protein in development for the treatment of hereditary angioedema (HAE).
- Dyax Announces FDA Accepts for Review the Complete Response Submission for DX-88 in Hereditary Angioedema - June 8, 2009
- Dyax Receives Complete Response Letter from FDA for DX-88 in Acute Attacks of Hereditary Angioedema - March 27, 2009
- FDA Advisory Committee Favors Approval of DX-88 for Acute Attacks of Hereditary Angioedema - February 5, 2009
- Dyax Announces FDA Advisory Committee to Review DX-88 for Hereditary Angioedema - January 13, 2009
- FDA Accepts Filing and Grants Priority Review for DX-88 for Hereditary Angioedema - November 21, 2008
- Dyax Announces Completion of Biologics License Application for DX-88 for Hereditary Angioedema - September 24, 2008
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 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: Abbott and AstraZeneca
Treatment for: Hyperlipidemia, Hypertriglyceridemia, Hyperlipoproteinemia
Certriad (rosuvastatin calcium and fenofibric acid) is a combination of the active ingredients in Crestor and Trilipix under investigation for the treatment of mixed dyslipidemia.
- Abbott and AstraZeneca Submit New Drug Application to the FDA for Certriad, an Investigational Treatment for Mixed Dyslipidemia - June 4, 2009
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 Files a New Drug Application for Tesamorelin With the US Food and Drug Administration - June 3, 2009
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