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: Johnson Pharmaceutical Research & Development, L.L.C.
Treatment for: Skin and Structure Infection
Ceftobiprole is an investigational antibiotic, for the treatment of complicated skin and skin structure infections (cSSSI), including diabetic foot infections, in adults.
- FDA Issues Complete Response Letter for Ceftobiprole for Treatment of Complicated Skin Infections - November 26, 2008
- FDA accepts for review the Complete Response to ceftobiprole NDA Approvable Letter - September 15, 2008
- FDA Issues Approvable Letter for Ceftobiprole for Treatment of Complicated Skin Infections - March 18, 2008
- FDA Published Today That It Will Not Hold an Advisory Committee Meeting on Ceftobiprole in the Treatment of Complicated Skin and Skin Structure Infections - February 13, 2008
- Basilea Announces Review of Ceftobiprole NDA at FDA Anti-Infective Drugs Advisory Committee Meeting - January 10, 2008
- U.S. FDA and European EMEA Accept Registration Applications for Ceftobiprole, Novel Anti-MRSA Broad-Spectrum Cephalosporin - July 18, 2007
- New Drug Application Submitted For Novel Investigational Antibiotic Ceftobiprole - May 18, 2007
Company: TAP Pharmaceutical Products Inc.
Treatment for: Gout
Febuxostat is a potent non-purine, selective inhibitor of xanthine oxidase which is under review for the treatment of hyperuricemia in patients with gout.
- Arthritis Advisory Committee Recommends FDA Approval of Febuxostat for the Treatment of Hyperuricemia in Patients With Gout - November 25, 2008
- TAP Submits New Drug Application for Febuxostat for the Management of Hyperuricemia in Chronic Gout - December 15, 2004
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.
- 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: Labopharm Inc.
Treatment for: Depression
DDS-04A (trazodone) is a once-daily serotonin antagonist reuptake inhibitor (SARI) formulation in development for the treatment of major depression.
- Labopharm's NDA for Novel Trazodone Formulation Accepted for Review by FDA - November 24, 2008
- Labopharm Submits New Drug Application to FDA for DDS-04A to Treat Major Depression - September 22, 2008
Company: Dyax Corp.
Treatment for: Angioedema
DX-88 (ecallantide) is a recombinant small protein that is currently in clinical trials for the treatment of hereditary angioedema (HAE).
- 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: Arpida Ltd.
Treatment for: Skin and Structure Infection
Iclaprim is a broad-spectrum diaminopyrimidine antibiotic in development for the treatment of complicated skin and skin structure infections.
- Arpida Comments on FDA's Anti-infective Drugs Advisory Committee Outcome - November 21, 2008
- Arpida Announces Review of Iclaprim NDA by FDA Advisory Committee in November 2008 - October 14, 2008
- Arpida Announces FDA Acceptance of the Iclaprim New Drug Application - May 16, 2008
- Arpida Submits New Drug Application for Intravenous Iclaprim for Treatment of Skin Infections - March 19, 2008
Company: Protherics PLC
Treatment for: Methotrexate Overdosage
Voraxaze (glucarpidase) is an investigational new drug that is available in the US under a Treatment Protocol for patients receiving high dose methotrexate who are experiencing or at risk of, methotrexate toxicity.
- Protherics PLC Voraxaze Rolling BLA Submission Initiated with the US FDA - November 20, 2008
Company: Ortho Biotech Products, L.P.
Treatment for: Ovarian Cancer
Trabectedin is an investigational cytotoxic antitumor agent used in combination with Doxil (doxorubicin HCl liposome injection) for the treatment of women with relapsed ovarian cancer.
- Ortho Biotech Announces NDA Submission for Trabectedin for the Treatment of Relapsed Ovarian Cancer - November 20, 2008
Company: Theravance Inc.
Treatment for: Skin and Structure Infection
Telavancin is a bactericidal, once-daily injectable antibiotic proposed to treat complicated skin and skin structure infections (cSSSI) caused by Gram-positive bacteria, including resistant pathogens such as methicillin-resistant Staphylococcus aureus (MRSA).
- Theravance Reports Favorable Outcome of FDA Advisory Committee Meeting on Telavancin for the Treatment of Complicated Skin and Skin Structure Infections - November 20, 2008
- FDA Accepts for Review Theravance's Complete Response to Approvable Letter for Telavancin for the Treatment of Complicated Skin and Skin Structure Infections - March 6, 2008
- Theravance Receives Notice of Possible Telavancin Review by FDA Advisory Committee - January 2, 2008
Company: Vanda Pharmaceuticals Inc.
Treatment for: Schizophrenia
Iloperidone is a 5HT2/D2 antagonist (atypical) antipsychotic in development for the treatment of schizophrenia.
- FDA Accepts Vanda Pharmaceuticals Iloperidone Resubmission and Sets New Action Date - November 20, 2008
- Vanda Pharmaceuticals Announces Receipt of Not Approvable Letter From FDA for Iloperidone - July 28, 2008
- Vanda Pharmaceuticals Receives FDA Acceptance of Iloperidone New Drug Application - November 27, 2007
- Vanda Pharmaceuticals Submits Iloperidone New Drug Application - September 27, 2007
Company: Salix Pharmaceuticals, Ltd.
Treatment for: Gastroesophageal Reflux Disease, Gastroparesis
Metozolv ODT is a fast–dissolving formulation of metoclopramide under review for the short–term treatment of adults with gastroesophageal reflux and for the relief of symptoms associated with diabetic gastroparesis.
- FDA Extends Metozolv ODT Review Date - November 18, 2008
Company: Altus Pharmaceuticals Inc.
Treatment for: Pancreatic Exocrine Dysfunction
Trizytek is a non-porcine derived enzyme replacement therapy in development for patients with pancreatic insufficiency.
- Altus Pharmaceuticals Reaffirms Plan to Submit New Drug Applicationfor Trizytek Approval - November 17, 2008
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.
- ISTA Pharmaceuticals Files New Drug Application with U.S. FDA for Bepreve - November 14, 2008
Company: AMAG Pharmaceuticals, Inc.
Treatment for: Anemia Associated with Chronic Renal Failure
Ferumoxytol is in the development pipeline as an iron replacement therapy for chronic kidney disease (CKD) patients whether or not on dialysis.
- AMAG Pharmaceuticals Announces Ferumoxytol Resubmission Designated Complete, Class 1 Response by the FDA - November 13, 2008
- AMAG Pharmaceuticals Receives Complete Response Letter from FDA for Ferumoxytol - October 20, 2008
- AMAG Pharmaceuticals, Inc. Announces FDA Acceptance for Filing of Ferumoxytol New Drug Application in Chronic Kidney Disease - February 19, 2008
- AMAG Pharmaceuticals, Inc. Submits New Drug Application to FDA for Ferumoxytol in Chronic Kidney Disease Patients - December 19, 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.
- 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: GlaxoSmithKline and XenoPort, Inc.
Treatment for: Restless Legs Syndrome
Solzira (gabapentin enacarbil) is a new chemical entity in development for the once-daily treatment of moderate-to-severe primary Restless Legs Syndrome.
- 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: 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 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: Sanofi-aventis
Treatment for: Obesity
Zimulti (rimonabant) is the first of a new therapeutic class of drugs that selectively blocks the CB1 receptors of the endocannabinoid system. Rimonabant is approved in the EU (as Acomplia) for the treatment of obesity with associated risk factors.
- Sanofi-aventis to Discontinue all Clinical Trials with rimonabant - November 6, 2008
- Rimonabant - Regulatory Update in Europe - November 14, 2007
- Committee for Medicinal Products for Human Use Post-authorisation Summary of Positive Opinion for Acomplia/Zimulti - July 19, 2007
- Rimonabant Regulatory Update in the United States - June 29, 2007
- Weight Loss Drug Rimonabant Can Cause Serious Physical and Psychological Harm and Birth Defects, Public Citizen Tells FDA - June 14, 2007
- FDA Advisory Committee Did Not Recommend Approval of Rimonabant (Zimulti) for Use in Obese and Overweight Patients With Associated Risks Factors - June 13, 2007
- Rimonabant USA: Update - March 26, 2007
- Sanofi-aventis Acknowledges FDA Announcement of an Advisory Committee Meeting for rimonabant - March 26, 2007
- Rimonabant USA: Update - February 12, 2007
- Rimonabant Update in the United States - December 8, 2006
- Sanofi-aventis Received from the FDA an Approvable Letter for Rimonabant for Weight Management and a Non Approvable Letter for Smoking Cessation - February 17, 2006
- Rimonabant Accepted for Filing By the FDA - June 23, 2005
Company: Salvat
Treatment for: Otitis Externa
Cetraxal (ciprofloxacin otic solution) is an antibiotic preparation under review for the treatment of acute otitis externa.
- Salvat Announces Submission of Complete Response to FDA Approvable Letter for Cetraxal - November 6, 2008
- Salvat Announces the FDA Acceptance of NDA for its Cetraxal Otic Solution - September 14, 2005
- SALVAT Files NDA for its Cetraxal Otic - Ciprofloxacin Otic- 0.2% Solution, for the Treatment of External Otitis - June 10, 2005
- Salvat Seeks FDA Approval for its Cetraxal Otic (Ciprofloxacin Otic) 0.2% Solution, for the Treatment of External Otitis - April 18, 2005
Company: Debiovision Inc.
Treatment for: Esophageal Varices with Bleeding
Sanvar (vapreotide acetate) is a somatostatin analogue in development for the treatment of acute esophageal variceal bleeding (EVB).
- Debiopharm Submits Response to the FDA for Sanvar (Debio 8609) for Esophageal Variceal Bleeding - November 6, 2008
- H3 Pharma Receives Approvable Letter from FDA for Sanvar for Esophageal Variceal Bleeding - January 5, 2005
- H3 Pharma Inc. Submits New Drug Application To FDA for Sanvar IR - March 2, 2004
New Drug Applications Archive
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