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: Lev Pharmaceuticals, Inc.
Treatment for: Angioedema
Cinryze is a C1-esterase inhibitor being developed as a comprehensive replacement therapy for the treatment of hereditary angioedema (HAE).
- Lev Announces FDA Advisory Committee Unanimously Recommends Approval of Cinryze for Hereditary Angioedema - May 2, 2008
- Lev Pharmaceuticals Announces Submission of Complete Response to FDA for Cinryze for Hereditary Angioedema - April 15, 2008
- Lev Announces FDA's Blood Products Advisory Committee to Review Cinryze (C1 inhibitor) - March 13, 2008
- Lev Pharmaceuticals Receives Complete Response Letter for Cinryze - January 31, 2008
- Lev Pharmaceuticals Amends Cinryze BLA to Include Prophylactic Data - October 30, 2007
- Lev's Cinryze BLA Accepted for Filing by FDA - October 1, 2007
- Lev Pharmaceuticals Submits Biologics License Application for Cinryze - July 31, 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 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: Pro-Pharmaceuticals, Inc.
Treatment for: Targeted Drug Delivery
- 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: AstraZeneca
Treatment for: Asthma -- Maintenance
Symbicort is a combination of a corticosteroid and a long-acting bronchodilator indicated for the long-term maintenance treatment of asthma in patients 12 years of age and older.
- AstraZeneca Submits an sNDA for Symbicort for COPD Indication - April 30, 2008
- AstraZeneca Submits New Drug Application (NDA) to FDA for Symbicort Maintenance Treatment of Asthma - September 23, 2005
Company: Acusphere Inc.
Imagify is an ultrasound imaging agent for the detection of coronary artery disease
- Acusphere Submits New Drug Application for FDA Approval of Imagify - April 29, 2008
Company: Merck & Co., Inc.
Treatment for: Hyperlipoproteinemia Type IIa (Elevated LDL), Hypertriglyceridemia
Cordaptive is an investigational compound containing extended-release niacin and laropiprant, a novel flushing pathway inhibitor designed to reduce flushing often associated with niacin treatment. Cordaptive is used either alone or with a statin, as adjunctive therapy to diet for the treatment of elevated LDL cholesterol, low HDL cholesterol and elevated triglyceride levels.
- Merck Receives Not Approvable Letter from FDA for MK-0524A (ER niacin/laropiprant) - April 29, 2008
- Merck Announces FDA Acceptance of NDA for Cordaptive (ER niacin/laropiprant), Formerly Known as MK-0524A, an Investigational Lipid-Modifier - August 29, 2007
Company: MediQuest Therapeutics Inc
a topical formulation designed to treat Raynaud 's Disease
Company: Schering-Plough/Merck Pharmaceuticals
Treatment for: Allergic Rhinitis
This medicine is a single tablet that contains the active ingredients of Claritin (loratadine) and Singulair (montelukast sodium), both of which are indicated for the relief of symptoms of allergic rhinitis.
- Schering-Plough/Merck Pharmaceuticals Receives Not-Approvable Letter from FDA for Loratadine/Montelukast - April 28, 2008
- Schering-Plough/Merck Pharmaceuticals Announce FDA Filing Acceptance of New Drug Application for Loratadine/Montelukast Tablet - August 28, 2007
Company: Jerini AG
Treatment for: Angioedema
Icatibant is a selective B2 bradykinin receptor antagonist in development for the treatment of hereditary angioedema (HAE).
- FDA Issues Not Approvable Letter for Icatibant in the Treatment of HAE - April 24, 2008
- FDA Cancels Advisory Committee Meeting for Icatibant in the Treatment of HAE - Priority Review of Jerini's NDA Continues - January 8, 2008
- Jerini Receives NDA Filing Acceptance and Priority Review from the FDA for Icatibant in the Treatment of HAE - December 21, 2007
- Jerini Submits New Drug Application for Icatibant in the Treatment of HAE to the FDA and Requests Priority Review - October 31, 2007
- Jerini Initiates FDA Submission Process of New Drug Application for Icatibant in the Treatment of HAE - October 8, 2007
Company: Addrenex Pharmaceuticals, Inc.
Treatment for: Hypertension
CloniBID is a 12-hour, sustained-release formulation of the centrally acting alpha-2 agonist clonidine hydrochloride under review for the treatment of hypertension.
- Sciele Pharma Announces FDA Acceptance of NDA for Addrenex Pharmaceuticals' CloniBID to Treat Hypertension - April 22, 2008
- Addrenex Pharmaceuticals Reaches Milestone with Filing of NDA for First Product, CloniBID, to Treat Hypertension - February 20, 2008
Company: Alpharma Inc.
Treatment for: Pain
Embeda is an abuse-deterrent, extended-release morphine preparation in development for the treatment of chronic pain.
- 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: 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 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: ChemGenex Pharmaceuticals
Treatment for: Chronic Myelogenous Leukemia
Omacetaxine mepesuccinate, a first-in-class small molecule which induces apoptosis by inhibition of protein synthesis is a new drug in development for the treatment of imatinib-resistant chronic myeloid leukemia (CML) patients with the T315I mutation.
- ChemGenex appoints VP Regulatory Affairs - Confirms Planned NDA Rolling Submission for Omacetaxine Following Meeting with U.S. FDA - April 14, 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 Plan to Submit NDA for Cethromycin - April 10, 2008
Company: Targanta Therapeutics Corporation
Treatment for: Skin and Structure Infection
Oritavancin is a semi-synthetic lipoglycopeptide antibiotic being developed for the treatment of complicated skin and skin structure infections (cSSSI) caused by gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).
- Targanta Announces FDA Acceptance of Oritavancin New Drug Application - April 9, 2008
- Targanta Submits Oritavancin New Drug Application - February 11, 2008
Company: Collegium Pharmaceutical, Inc.
AllerNase (triamcinolone acetonide, USP) Nasal Spray is an aqueous based intranasal steroid under review for the once daily treatment of nasal symptoms associated with both seasonal and perennial allergic rhinitis in adults and children twelve years of age and older.
- Collegium Pharmaceutical Announces FDA Filing for AllerNase, a Nasal Inhaled Steroid for the Treatment of Allergic Rhinitis - April 8, 2008
Company: SIGA Technologies, Inc.
Treatment for: Exposure to Smallpox Virus
ST-246 is an orally active, smallpox antiviral in development to treat individuals exposed to the smallpox virus in the event of an outbreak.
- SIGA Initiates Manufacture of ST-246 NDA Registration Batches - April 4, 2008
- SIGA Files Application Supporting Emergency Use Approval for ST-246 - March 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 Submits New Drug Application for Intravenous Iclaprim for Treatment of Skin Infections - March 19, 2008
New Drug Applications Archive
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