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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.


Company: Paratek Pharmaceuticals, Inc.
Treatment for: Pneumonia, Skin and Structure Infection

Omadacycline is an aminomethylcycline tetracycline antibiotic in development for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).

ALKS 5461 (buprenorphine and samidorphan)

Company: Alkermes plc
Treatment for: Major Depressive Disorder

ALKS 5461 (buprenorphine and samidorphan) is a novel opioid modulator, combining a partial opioid agonist with an opioid antagonist to rebalance brain function in patients with treatment-resistant depression.


Company: Theravance Biopharma, Inc.
Treatment for: Chronic Obstructive Pulmonary Disease

Revefenacin is an investigational long-acting muscarinic antagonist (LAMA) in development for the treatment of chronic obstructive pulmonary disease (COPD).

Linhaliq (ciprofloxacin liposomal) for Inhalation

Company: Aradigm Corporation

Linhaliq is an inhalation formulation of liposome encapsulated and unencapsulated ciprofloxacin in development for the treatment of non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic lung infections with Pseudomonas aeruginosa.

Altreno (tretinoin) Lotion

Company: Ortho Dermatologics
Treatment for: Acne

Altreno (tretinoin) is a topical lotion formulation of the approved drug tretinoin in development for the treatment of acne.

Tlando (testosterone) - formerly LPCN 1021

Company: Lipocine Inc.
Treatment for: Hypogonadism -- Male

Tlando (testosterone) is an oral testosterone replacement therapy in development for the treatment of males with conditions associated with a deficiency or absence of endogenous testosterone, also known as hypogonadism.


Company: Ionis Pharmaceuticals, Inc.
Treatment for: Amyloidogenic Transthyretin Amyloidosis

Inotersen is an antisense oligonucleotide inhibitor of the transthyretin (TTR) protein in development for the treatment of of patients with hereditary TTR amyloidosis (hATTR).


Company: Merck
Treatment for: HIV Infection

Doravirine is an investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) in development for the treatment of HIV-1 infection in adults.

Inveltys (loteprednol etabonate)

Company: Kala Pharmaceuticals, Inc.
Treatment for: Postoperative Ocular Inflammation

Inveltys (loteprednol etabonate) is a nanoparticle ocular corticosteroid formulation in development for the treatment of post-operative ocular inflammation and pain.


Company: Mallinckrodt plc
Treatment for: Hyperbilirubinemia

Stannsoporfin is a heme oxygenase inhibitor in development for the treatment of neonates at risk for developing severe hyperbilirubinemia, or severe jaundice.

Olinvo (oliceridine) Injection

Company: Trevena, Inc.
Treatment for: Pain

Olinvo (oliceridine) is a G protein biased ligand of the mu opioid receptor, a new class of opioid receptor modulator in development for the treatment of moderate-to-severe acute pain.


Company: Tetraphase Pharmaceuticals, Inc.
Treatment for: Intraabdominal Infection

Eravacycline is a fluorocycline antibiotic in development for the treatment of serious infections, including those caused by multidrug-resistant (MDR) pathogens.

Azedra (iobenguane I 131)

Company: Progenics Pharmaceuticals Inc.
Treatment for: Pheochromocytoma; Paraganglioma

Azedra (iobenguane I 131) is a radiotherapeutic product in development as a treatment for malignant and/or recurrent pheochromocytoma and paraganglioma.

Epidiolex (cannabidiol)

Company: GW Pharmaceuticals plc
Treatment for: Lennox-Gastaut Syndrome, Dravet Syndrome

Epidiolex (cannabidiol) is a cannabinoid product in development for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome.

TX-001HR (estradiol and progesterone)

Company: TherapeuticsMD, Inc.
Treatment for: Perimenopausal Symptoms

TX-001HR is an investigational bio-identical hormone combination of estradiol and progesterone in development for the treatment of moderate-to-severe vasomotor symptoms due to menopause.


Company: Agios Pharmaceuticals, Inc.
Treatment for: Acute Myeloid Leukemia

Ivosidenib is an investigational, first-in-class, isocitrate dehydrogenase-1 (IDH1) inhibitor in development for the treatment of patients with relapsed or refractory acute myeloid leukemia (R/R AML) and an IDH1 mutation.

Twirla (ethinyl estradiol and levonorgestrel) Transdermal System

Company: Agile Therapeutics, Inc.
Treatment for: Contraception

Twirla (ethinyl estradiol and levonorgestrel transdermal system) is an investigational low-dose combined hormonal contraceptive.

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

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