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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.

Vesneo (latanoprostene bunod) Ophthalmic Solution

Company: Valeant Pharmaceuticals International, Inc.
Treatment for: Glaucoma (Open Angle), Intraocular Hypertension

Vesneo (latanoprostene bunod ophthalmic solution) is a nitric oxide donating prostaglandin receptor agonist in development for the treatment of patients with open angle glaucoma or ocular hypertension.

binimetinib

Company: Array BioPharma
Treatment for: NRAS-Mutant Melanoma

Binimetinib is a late-stage small molecule MEK inhibitor in development for the treatment of advanced NRAS-mutant melanoma.

abaloparatide

Company: Radius Health, Inc.
Treatment for: Osteoporosis

Abaloparatide is a synthetic peptide analog of hPTHrP (human parathyroid hormone-related protein) in development for the treatment of postmenopausal women with osteoporosis.

Zerviate (cetirizine) Ophthalmic Solution - formerly AC-170

Company: Nicox S.A.
Treatment for: Allergic Conjunctivitis

Zerviate (cetirizine) is a second generation antihistamine topical ophthalmic formulation in development for the treatment of ocular itching associated with allergic conjunctivitis.

enasidenib

Company: Celgene Corporation
Treatment for: Acute Myeloid Leukemia

Enasidenib is a first-in-class, oral, targeted inhibitor of mutant isocitrate dehydrogenase 2 (IDH2) in development for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) with an IDH2 mutation.

ertugliflozin

Company: Merck
Treatment for: Diabetes Type 2

Ertugliflozin is a sodium-glucose cotransporter-2 (SGLT2) inhibitor in development to help improve glycemic control in adults with type 2 diabetes.

Rhopressa (netarsudil) Ophthalmic Solution

Company: Aerie Pharmaceuticals, Inc.
Treatment for: Glaucoma

Rhopressa (netarsudil ophthalmic solution) is a combination Rho Kinase and norepinephrine transporter (ROCK/NET) inhibitor in development for the treatment of glaucoma or ocular hypertension.

Bavencio (avelumab) Injection

Company: EMD Serono Inc.
Treatment for: Merkel Cell Carcinoma

Bavencio (avelumab) is a programmed death ligand-1 (PD-L1) blocking antibody indicated for the treatment of patients with metastatic Merkel cell carcinoma (MCC).

DSUVIA (sufentanil) Sublingual Tablets - formerly ARX-04

Company: AcelRx Pharmaceuticals, Inc.
Treatment for: Pain

DSUVIA (sufentanil) is a synthetic opioid analgesic administered sublingually by a healthcare professional for the treatment of patients experiencing moderate-to-severe acute pain in a medically supervised setting.

Dextenza (dexamethasone) Intracanalicular Depot

Company: Ocular Therapeutix, Inc.
Treatment for: Postoperative Ocular Inflammation

Dextenza (dexamethasone) is an investigational intracanalicular depot corticosteroid formulation delivering sustained release dexamethasone to the ocular surface for the treatment of post-surgical ocular inflammation and pain.

Carbavance (meropenem and vaborbactam) Injection

Company: The Medicines Company
Treatment for: Urinary Tract Infection

Carbavance (meropenem and vaborbactam) is a fixed combination of meropenem, a carbapenem, and vaborbactam, a novel beta-lactamase inhibitor, in development for the treatment of complicated urinary tract infections (cUTIs).

inotuzumab ozogamicin

Company: Pfizer Inc.
Treatment for: Acute Lymphoblastic Leukemia

Inotuzumab ozogamicin is a CD22 monoclonal antibody and calicheamicin cytotoxic agent conjugate in development for the treatment of patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

Zilretta (triamcinolone acetonide) Sustained-Release Intra-Articular Injection

Company: Flexion Therapeutics, Inc.
Treatment for: Osteoarthritis

Zilretta (triamcinolone acetonide) is a sustained-release corticosteroid polymer (PLGA) formulation intended to provide persistent concentrations of drug locally to amplify the magnitude and prolong the duration of pain relief in patients with osteoarthritis of the knee.

CL-108 (acetaminophen, hydrocodone and promethazine)

Company: Charleston Laboratories, Inc. and Daiichi Sankyo, Inc.
Treatment for: Pain, Nausea/Vomiting

CL-108 (acetaminophen, hydrocodone and promethazine) is an analgesic and antihistamine fixed-dose combination in development for the relief of moderate to severe pain while preventing or reducing the associated opioid-induced nausea and vomiting (OINV).

glecaprevir and pibrentasvir

Company: AbbVie Inc.
Treatment for: Chronic Hepatitis C

Glecaprevir/pibrentasvir (G/P) is a fixed-dose combination of glecaprevir, an NS3/4A protease inhibitor, and pibrentasvir, an NS5A inhibitor, in development for the treatment of all major genotypes (GT1-6) of chronic hepatitis C.

Rexista (oxycodone hydrochloride) Extended-Release Tablets

Company: Intellipharmaceutics International Inc.
Treatment for: Pain

Rexista (oxycodone hydrochloride extended release) is an abuse and alcohol-deterrent controlled-release formulation of oxycodone hydrochloride in development for the relief of moderate to severe pain.

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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