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: 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
Company: Alpharma Inc.
Treatment for: Pain
Embeda is an abuse-deterrent, extended-release morphine preparation in development for the treatment of chronic pain.
- Alpharma Announces Acceptance of the Embeda Capsule NDA Filing - September 2, 2008
- Alpharma Announces the Resubmission of a New Drug Application for Embeda Capsules - July 1, 2008
- Alpharma to Withdraw and Resubmit Its New Drug Application for Embeda - April 22, 2008
- Alpharma Submits New Drug Application for Embeda - February 29, 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 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: Elan Corporation, plc and Johnson & Johnson Pharmaceutical Research & Development, L.L.C
Treatment for: Schizophrenia
Paliperidone palmitate is an investigational, once-monthly atypical antipsychotic intramuscular injection for the treatment of schizophrenia and the prevention of recurrence of the symptoms of schizophrenia. Paliperidone palmitate is a long acting injectable ester of the active ingredient in Invega.
- FDA Issues Complete Response Letter for Paliperidone Palmitate for the Treatment of Schizophrenia - August 27, 2008
- Elan Announces the Johnson & Johnson Pharmaceutical Research & Development Submission of a New Drug Application to the FDA for Paliperidone Palmitate Using Elan's Proprietary NanoCrystal Technology - October 29, 2007
Company: Cardiome Pharma Corp.
Treatment for: Atrial Fibrillation
Kynapid (vernakalant iv) is the intravenous formulation of an investigational drug being evaluated for the acute conversion of atrial fibrillation (AF). Vernakalant selectively blocks ion channels in the heart that are known to be active during episodes of atrial fibrillation.
- Cardiome And Astellas Announce Receipt Of FDA Approvable Letter For Kynapid - August 11, 2008
- Cardiome And Astellas Announce Kynapid Regulatory Update - January 22, 2008
- FDA Advisory Committee Recommends Approval of Kynapid for Acute Atrial Fibrillation - December 12, 2007
- Cardiome And Astellas Announce Regulatory Extension - August 30, 2007
- Cardiome And Astellas Announce Acceptance Of NDA For Review - February 19, 2007
- Cardiome and Astellas Pharma US, Inc. Announce Re-Submission of NDA for Vernakalant (IV) - December 18, 2006
- Cardiome Announces Refusal to File Decision By the FDA - May 31, 2006
- New Drug Application Submitted For RSD1235 - March 31, 2006
Company: Sanofi-aventis
Treatment for: Atrial Fibrillation, Atrial Flutter
Multaq (dronedarone) is a multi-channel blocker that affects calcium, potassium and sodium channels and has anti-adrenergic properties. Multaq is an investigational treatment for patients with atrial fibrillation and atrial flutter.
- Multaq (dronedarone) Granted FDA Priority Review for Patients with Atrial Fibrillation - August 8, 2008
Company: Centocor, Inc.
Treatment for: Psoriasis
Ustekinumab is a new human monoclonal antibody in development for the treatment of moderate to severe plaque psoriasis.
- FDA Extends Review Timeline for Ustekinumab Biologic License Application Three Months - August 8, 2008
- FDA Advisory Committee Unanimously Recommends Approval of Ustekinumab for Treatment of Moderate to Severe Plaque Psoriasis - June 18, 2008
- Centocor Announces Ustekinumab Biologic License Application Accepted for Filing by FDA - February 4, 2008
- Medarex to Receive Milestone Payment for Submission of Regulatory Applications Requesting Approval of Ustekinumab (CNTO 1275) for Treatment of Psoriasis - December 7, 2007
- Centocor and Janssen-Cilag Submit Applications Requesting Approval of Ustekinumab in the U.S. and Europe for Treatment of Moderate to Severe Plaque Psoriasis - December 4, 2007
Company: Othera Pharmaceuticals, Inc.
Treatment for: Glaucoma
OT-730 is an oculoselective beta-blocker under review as a potential treatment for glaucoma.
- Othera Files IND Application for OT-730 in Glaucoma - August 7, 2008
Company: GTC Biotherapeutics, Inc.
Treatment for: Antithrombin III Deficiency
ATryn (antithrombin alfa) is a recombinant form of human antithrombin under review for the prophylactic treatment of deep vein thrombosis and other thromboembolisms in patients with hereditary antithrombin deficiency who are undergoing high risk surgical and childbirth procedures.
- GTC Biotherapeutics Completes BLA Submission For ATryn - August 7, 2008
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 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: Schering-Plough Corporation
Treatment for: Reversal of Nondepolarizing Muscle Relaxants
Sugammadex is a novel selective relaxant binding agent (SRBA) specifically designed to reverse the effects of rocuronium bromide (Zemuron/Esmeron/Eslax) or vecuronium bromide, muscle relexants commonly used during surgical procedures.
- U.S. FDA Issues Action Letter for Sugammadex - August 1, 2008
- FDA Advisory Committee Unanimously Recommends U.S. Approval of Sugammadex, the First and Only Selective Relaxant Binding Agent - March 12, 2008
- Schering-Plough Announces New Drug Application for Sugammadex Assigned Priority Review Status by U.S. FDA - January 3, 2008
Company: Johnson & Johnson Pharmaceutical Research and Development
Treatment for: Deep Vein Thrombosis Prophylaxis after Knee Replacement Surgery, Deep Vein Thrombosis Prophylaxis after Hip Replacement Surgery
Xarelto (rivaroxaban) is a novel once-daily anticoagulant in development for the prevention of deep vein thrombosis and pulmonary embolism in patients undergoing hip or knee replacement surgery.
- Venous Blood Clot Prevention after Hip or Knee Replacement Surgery: Bayer’s Novel Anticoagulant Rivaroxaban Submitted for Approval in the U.S. - July 30, 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 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: UCB
Treatment for: Diabetic Neuropathy, Seizures
Vimpat (lacosamide) is an investigational anti-convulsant drug for the treatment of partial onset seizures in adults with epilepsy. Vimpat is also under review for the treatment of diabetic neuropathic pain.
- UCB Receives Not-Approvable Letter from FDA for Lacosamide for Diabetic Neuropathic Pain - July 29, 2008
- UCB Announces FDA Filing for lacosamide in the Treatment of Partial Onset Seizures in Adults with Epilepsy - November 29, 2007
- UCB Announces FDA Filing for lacosamide in the Treatment of Diabetic Neuropathic Pain - November 28, 2007
Company: Orexo and Meda AB
Sublinox is a sublingual tablet formulation of the widely used drug zolpidem. Sublinox is being developed to provide fast, effective absorption for the short term treatment of insomnia.
- Meda: The FDA has accepted for filing the registration application for Sublinox - July 29, 2008
- Orexo Has Submitted the Registration Application for Sublinox (OX22) to the FDA - May 15, 2008
Company: Vanda Pharmaceuticals Inc.
Treatment for: Schizophrenia
Iloperidone is a 5HT2/D2 antagonist (atypical) antipsychotic in development for the treatment of schizophrenia.
- 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: MGI Pharma, Inc.
Treatment for: Sedation
Aquavan (fospropofol disodium) is a water-soluble prodrug of propofol in development for sedation of patients undergoing short surgical or diagnostic procedures.
- Eisai Receives Action Letter on Fospropofol Disodium Injection for Sedation in Diagnostic or Therapeutic Procedures - July 28, 2008
- MGI Pharma Announces Aquavan NDA Accepted for Review by U.S. FDA - December 17, 2007
- MGI Pharma Announces Submission of Aquavan NDA - September 27, 2007
Company: Bristol-Myers Squibb Company and AstraZeneca
Treatment for: Diabetes Mellitus Type II
Onglyza (saxagliptin) is an investigational DPP-4 inhibitor for the treatment of type 2 diabetes.
Company: NexMed, Inc.
Treatment for: Erectile Dysfunction
Alprox-TD is a topically applied alprostadil cream in development for the treatment of erectile dysfunction.
- NexMed Receives FDA Response for Topical ED Product - July 23, 2008
- NexMed Confirms FDA Acceptance of NDA for Erectle Dysfunction Product - November 20, 2007
- NexMed Files NDA for Proprietary Erectile Dysfunction Treatment - September 24, 2007
Company: Xanodyne Pharmaceuticals, Inc.
Treatment for: Pain
Zipsor is a rapid release diclofenac potassium formulation in development for the treatment of patients with mild to moderate acute pain.
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