New Drug Applications

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

Motavizumab

Company: MedImmune, Inc.

Treatment for: Respiratory Syncytial Virus

Motavizumab is an investigational monoclonal antibody (MAb) in development for the prevention of serious disease caused by respiratory syncytial virus (RSV) in high-risk pediatric patients.

MedImmune Receives FDA Complete Response Letter on Motavizumab - December 1, 2008
MedImmune Submits Biologics License Application to FDA for Motavizumab - February 4, 2008

Ceftobiprole

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

Febuxostat

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

Silenor (doxepin HCl)

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

DDS-04A (trazodone)

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

DX-88 (ecallantide)

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

Iclaprim Intravenous Injection

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

Voraxaze (glucarpidase)

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

Trabectedin

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

Telavancin Injection

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).

Iloperidone

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

Metozolv ODT (metoclopramide) Orally Disintegrating Tablets

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

Trizytek (liprotamase)

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

Bepreve (bepotastine) Ophthalmic Solution

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

Ferumoxytol Intravenous Injection

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

Surfaxin (lucinactant)

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

Solzira (gabapentin enacarbil)

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.

Onsolis (fentanyl) - formerly BEMA Fentanyl

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

Zimulti (rimonabant) - formerly Acomplia

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.