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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 the FDA's How Drugs are Developed and Approved page.

LIQ861 (treprostinil) Inhalation Powder

Company: Liquidia Technologies, Inc.
Treatment for: Pulmonary Arterial Hypertension (PAH)

LIQ861 (treprostinil) is an investigational inhaled dry powder formulation of treprostinil in development for the treatment of pulmonary arterial hypertension (PAH).

Defencath (taurolidine)

Company: CorMedix Inc.
Treatment for: Prevention of Catheter Related Blood Stream Infections (CRBSI)

Defencath (taurolidine) is a synthetic broad-spectrum antimicrobial and antifungal in development for use as a catheter lock solution in hemodialysis patients for the prevention of catheter related blood stream infections (CRBSI).

ALKS 3831 (olanzapine and samidorphan)

Company: Alkermes plc
Treatment for: Schizophrenia, Bipolar Disorder

ALKS 3831 (olanzapine and samidorphan) is an investigational, once-daily, oral atypical antipsychotic combination of an established antipsychotic agent (olanzapine) and a novel μ-opioid receptor antagonist (samidorphan) in development for the treatment of schizophrenia and bipolar I disorder.

pegcetacoplan

Company: Apellis Pharmaceuticals,?Inc.
Treatment for: Paroxysmal Nocturnal Hemoglobinuria

Pegcetacoplan is an investigational, targeted C3 inhibitor in development for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).

Zimhi (naloxone hydrochloride) Injection

Company: Adamis Pharmaceuticals Corporation
Treatment for: Opioid Overdose

Zimhi (naloxone hydrochloride) is a high-dose formulation of the approved opioid antagonist naloxone in development for the treatment of opioid overdose.

sutimlimab

Company: Sanofi
Treatment for: Cold Agglutinin Disease (CAD)

Sutimlimab is a first-in-class selective inhibitor of complement C1s in development for the treatment of hemolysis in adult patients with cold agglutinin disease (CAD).

SPN-812 (viloxazine hydrochloride)

Company: Supernus Pharmaceuticals, Inc.
Treatment for: Attention Deficit Hyperactivity Disorder (ADHD)

SPN-812 (viloxazine hydrochloride) is a serotonin norepinephrine modulating agent (SNMA) in development as a novel, non-stimulant treatment for attention deficit hyperactivity disorder (ADHD).

vosoritide

Company: BioMarin Pharmaceutical Inc.
Treatment for: Achondroplasia

Vosoritide is an investigational, once daily injection analog of C-type Natriuretic Peptide (CNP) in development for the treatment of children with achondroplasia.

Qtrypta (zolmitriptan)

Company: Zosano Pharma Corporation
Treatment for: Migraine

Qtrypta is a proprietary formulation of zolmitriptan that utilizes Dermally-Applied Microarray (ADAM) technology (drug-coated microneedles) in development for the acute treatment of migraine.

ibrexafungerp

Company: Scynexis, Inc.
Treatment for: Vaginal Candidiasis

Ibrexafungerp is a first-in-class triterpenoid antifungal agent in development for the treatment of vulvovaginal candidiasis.

belumosudil

Company: Kadmon Holdings, Inc.
Treatment for: Graft Versus Host Disease

Belumosudil (KD025) is a selective oral inhibitor of Rho-associated coiled-coil kinase 2 (ROCK2) in development for the treatment of patients with chronic graft-versus-host disease (cGVHD).

BBP-870 (fosdenopterin)

Company: BridgeBio Pharma, Inc.
Treatment for: Molybdenum Cofactor Deficiency (MoCD) Type A

BBP-870 (fosdenopterin) is an investigative cyclic pyranopterin monophosphate (cPMP) substrate replacement therapy in development for the treatment of patients with molybdenum cofactor deficiency (MoCD) Type A.

Libervant (diazepam) Buccal Film

Company: Aquestive Therapeutics, Inc.
Treatment for: Seizure Clusters

Libervant (diazepam) is a buccal film formulation of the approved benzodiazepine diazepam in development for the management of seizure clusters.

loncastuximab tesirine

Company: ADC Therapeutics SA
Treatment for: Diffuse Large B-cell Lymphoma

Loncastuximab tesirine (Lonca, formerly ADCT-402) is an antibody drug conjugate (composed of a humanized monoclonal antibody directed against human CD19 and conjugated through a linker to a pyrrolobenzodiazepine (PBD) dimer cytotoxin) in development for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

idecabtagene vicleucel

Company: Bristol Myers Squibb
Treatment for: Multiple Myeloma

Idecabtagene vicleucel (ide-cel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous chimeric antigen receptor (CAR) T cell immunotherapy in development for the treatment of adult patients with multiple myeloma who have received at least three prior therapies.

See also: Generic Approvals, New Drug Approvals, Recent Additions to Drugs.com, Alphabetical Listing of all New Drug Applications, FDA Approval Process

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