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: 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 Submits New Drug Application for Intermezzo for Treatment of Middle-of-the-Night Awakenings - October 1, 2008

Company: Medivir

Treatment for: Herpes Simplex Labialis

Lipsovir is topical combination of hydrocortisone (an anti-inflammatory agent) and acyclovir (an antiviral agent) in development for the prevention and treatment of cold sores.

• New Drug Application (NDA) for Lipsovir submitted to US FDA - October 1, 2008

Company: Advanced Life Sciences Holdings, Inc.

Treatment for: Pneumonia

Cethromycin is a once-a-day oral antibiotic in development as a treatment for mild-to-moderate community acquired pneumonia (CAP).

• Advanced Life Sciences Announces NDA Submission for Cethromycin in Community Acquired Pneumonia - October 1, 2008
• Advanced Life Sciences Announces Plan to Submit NDA for Cethromycin - April 10, 2008

Company: Daiichi Sankyo Company, Limited and Eli Lilly and Company

Treatment for: Acute Coronary Syndrome

Effient (prasugrel) is an oral antiplatelet agent in development for the treatment of patients with acute coronary syndrome (ACS) who are managed with percutaneous coronary intervention including coronary stenting.

• FDA Continues to Review Prasugrel New Drug Application - September 29, 2008
• FDA Extends Review Period for Daiichi Sankyo, Lilly Investigative Antiplatelet Drug, Prasugrel - June 24, 2008
• FDA Grants Priority Review for Daiichi Sankyo, Lilly Drug, Prasugrel - February 22, 2008
• Daiichi Sankyo, Lilly Submit New Drug Application for Investigational Antiplatelet Drug, Prasugrel, with U.S. Food and Drug Administration - January 4, 2008

Company: Indevus Pharmaceuticals, Inc.

Treatment for: Hypogonadism -- Male

Nebido is a long-acting depot preparation of testosterone undecanoate, developed for the treatment of male hypogonadism. Nebido is expected to be the first three-month testosterone preparation available in the U.S.

• Indevus and FDA Agree on Path Forward for Nebido - September 26, 2008
• Indevus Receives Approvable Letter from FDA for Nebido - June 30, 2008
• Indevus Pharmaceuticals Provides Update on Nebido NDA Status - June 4, 2008
• FDA Accepts New Drug Application for Nebido Submitted by Indevus - November 1, 2007
• Indevus Announces Submission of New Drug Application for Nebido - August 28, 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.

• 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: Takeda Pharmaceutical Company Limited

Treatment for: Diabetes Mellitus Type II

Alogliptin (SYR-322) and Actos (pioglitazone HCl) ("alogliptin/Actos") is a combination of a DPP-4 inhibitor and a thiazolidinedione in development for the treatment of type 2 diabetes.

• Takeda Submits a New Drug Application in the U.S. for Alogliptin (SYR-322) / Actos (pioglitazone HCl) for the Treatment of Type 2 Diabetes - September 24, 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).

• Dyax Announces Completion of Biologics License Application for DX-88 for Hereditary Angioedema - September 24, 2008

Company: Genzyme Corporation

Treatment for: Stem Cell Mobilization

Mozobil is a small molecule CXCR4 chemokine receptor antagonist which enhances mobilization of hematopoietic stem cells for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma.

• Genzyme Announces FDA Priority Review for Mozobil New Drug Application - September 23, 2008
• Genzyme Files Applications for Approval of Mozobil in the United States and Europe - June 17, 2008

Company: ARCA biopharma, Inc.

Treatment for: Congestive Heart Failure

Bucindolol is an investigational and pharmacologically unique beta-blocker and mild vasodilator in development for the treatment of chronic heart failure.

• FDA Accepts New Drug Application for Bucindolol, A Genetically-Targeted Treatment for Heart Failure From ARCA biopharma - September 23, 2008

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 Submits New Drug Application to FDA for DDS-04A to Treat Major Depression - September 22, 2008

Company: NovaDel Pharma, Inc.

Treatment for: Insomnia

ZolpiMist is an oral spray formulation of zolpidem, the drug contained in Ambien. ZolpiMist is being studied for the short-term treatment of insomnia.

• NovaDel Pharma Announces PDUFA Deadline Extension on Zolpimist - September 19, 2008
• NovaDel's New Drug Application for ZolpiMist Oral Spray to Treat Insomnia Accepted for Filing by the U.S. Food and Drug Administration - January 23, 2008

Company: Roche

Treatment for: Rheumatoid Arthritis

Actemra (tocilizumab) is a humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody in development for the treatment of moderate to severe rheumatoid arthritis in adults.

• FDA Issues Complete Response Letter to Roche for Acterma (tocilizumab) Biologics License Application - September 18, 2008
• FDA Advisory Committee Recommends Approval of Actemra (tocilizumab) for the Treatment of Rheumatoid Arthritis - July 29, 2008
• Roche Submits Application for FDA Approval of Actemra for the Treatment of Rheumatoid Arthritis - November 21, 2007

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 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: 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 Submission of NDA Requesting FDA Approval of Solzira for Restless Legs Syndrome - September 16, 2008

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 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: Lundbeck A/S

Treatment for: Schizophrenia

Serdolect (sertindole) is an antipsychotic drug for the treatment of schizophrenia without sedative effect and with placebo level extrapyramidal symptoms (EPS).

• Lundbeck Submits New Drug Application (NDA) for Serdolect in the US for the Treatment of Schizophrenia - September 15, 2008

Company: Pro-Pharmaceuticals, Inc.

Treatment for: Targeted Drug Delivery

Davanat is a polysaccharide polymer comprised of mannnose and galactose in development for the targeted delivery of drugs used in the treatment of cancer.

• Pro-Pharmaceuticals Submits Data to FDA for Davanat NDA to Treat Advanced Colorectal Cancer - September 15, 2008
• Pro-Pharmaceuticals Announces Submission of Drug Master File for Davanat to FDA - May 20, 2008
• Pro-Pharmaceuticals Updates NDA Filing for Davanat - May 1, 2008
• Pro-Pharmaceuticals Selects SAFC, a Division of Sigma-Aldrich, to Submit a Drug Master File - December 19, 2007
• Pro-Pharmaceuticals Submits Data to Begin a 505 (b)(2) Filing with the FDA for a New Formulation of Irinotecan to be Co-administered with Davanat as a Functional Excipient - June 11, 2007
• Pro-Pharmaceuticals Receives Letter from the FDA for New Drug Application for Davanat/ 5-FU - April 11, 2007
• Pro-Pharmaceuticals' Begins Process of New Drug Application Submission with the FDA for Co-administration of Davanat with 5-FU in Cancer Patients - February 7, 2007

Company: Pfizer Inc.

Treatment for: Skin and Structure Infection

Dalbavancin is a member of the glycopeptide class of antibiotics under FDA review for the treatment of adult patients with complicated skin and skin structure infections, including those caused by methicillin-resistant Staphylococcus aureus (MRSA).

• Pfizer Will Withdraw Global Marketing Applications for Dalbavancin to Conduct a New Trial - September 9, 2008
• Pfizer Receives Approvable Letter from FDA for Dalbavancin - December 21, 2007
• Vicuron Pharmaceuticals Receives Issued Patent for Dalbavancin Dosing by U.S. Patent and Trademark Office - June 2, 2005
• Vicuron Pharmaceuticals Announces Extension of FDA Review of Dalbavancin New Drug Application - May 11, 2005
• Vicuron Pharmaceuticals Granted Priority Review of Dalbavancin NDA by FDA in Complicated Skin and Soft Tissue Infections - February 24, 2005
• Vicuron Pharmaceuticals Submits New Drug Application for Dalbavancin to U.S. Food and Drug Administration - December 21, 2004

Company: Introgen Therapeutics, Inc.

Treatment for: Head and Neck Cancer

Advexin is a targeted molecular therapy in phase 3 clinical trials for the treatment of head and neck cancer.

• Introgen Receives Notice Advexin U.S. BLA Not Sufficiently Complete to File - September 2, 2008
• Introgen Submits Advexin Regulatory Applications in the U.S. and Europe - June 30, 2008
• Introgen Plans to Expand Biomarker Database in Phase 3 Trials and File BLA and MAA for Advexin in Advanced Head and Neck Cancer in First Half of 2008 - December 20, 2007

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