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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



Cinryze (C1 inhibitor)

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).


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.


Davanat

Company: Pro-Pharmaceuticals, Inc.

Treatment for: Targeted Drug Delivery


Symbicort (budesonide and formoterol) Inhaler

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.


Imagify (perflubutane)

Company: Acusphere Inc.

Imagify is an ultrasound imaging agent for the detection of coronary artery disease


Cordaptive (niacin ER and laropiprant)

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.


MQX-503 topical

Company: MediQuest Therapeutics Inc

a topical formulation designed to treat Raynaud 's Disease


Loratadine/Montelukast

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.


Icatibant

Company: Jerini AG

Treatment for: Angioedema

Icatibant is a selective B2 bradykinin receptor antagonist in development for the treatment of hereditary angioedema (HAE).


CloniBID (clonidine hydrochloride)

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.


Embeda (morphine extended-release)

Company: Alpharma Inc.

Treatment for: Pain

Embeda is an abuse-deterrent, extended-release morphine preparation in development for the treatment of chronic pain.


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.



omacetaxine mepesuccinate

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.


cethromycin

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).


Oritavancin

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).


AllerNase (triamcinolone acetonide) Nasal Spray

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.


ST-246

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.



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.

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New Drug Applications Archive

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