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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.

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.

OPN-375 (fluticasone)

Company: OptiNose US Inc.
Treatment for: Nasal Polyps

OPN-375 (fluticasone) is a topical steroid delivery system in development for the local treatment of nasal polyposis.

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.

SHP465

Company: Shire plc
Treatment for: Attention-Deficit/Hyperactivity Disorder (ADHD)

SHP465 is a long-acting, triple-bead, mixed amphetamine salts formulation in development as a potential once-daily treatment for Attention-Deficit/Hyperactivity Disorder (ADHD).

Solosec (secnidazole) Oral Granules

Company: Symbiomix Therapeutics
Treatment for: Bacterial Vaginosis

Solosec (secnidazole) is a potent, next-generation, investigational 5-nitroimidazole antibiotic with enhanced pharmacokinetic properties anticipated to be the first and only single-dose oral therapy approved for the treatment of bacterial vaginosis (BV).

EZR-104 (valsartan)

Company: Ezra Innovations, LLC
Treatment for: Hypertension, Congestive Heart Failure

EZR-104 (valsartan) is a novel formulation of the angiotensin receptor blocker valsartan, with patented RubiretenTM delivery technology, in development for the treatment of hypertension and heart failure.

Cinvanti (aprepitant) Injection

Company: Heron Therapeutics, Inc.
Treatment for: Nausea/Vomiting -- Chemotherapy Induced

Cinvanti (aprepitant) is a polysorbate 80 free, intravenous formulation of aprepitant, an NK1 receptor antagonist indicated for the prevention of chemotherapy-induced nausea and vomiting (CINV).

baricitinib

Company: Eli Lilly and Company and Incyte Corporation
Treatment for: Rheumatoid Arthritis

Baricitinib is an oral selective JAK1 and JAK2 inhibitor in development for the treatment of rheumatoid arthritis.

MYL-1401O (trastuzumab)

Company: Mylan N.V. and Biocon Ltd.
Treatment for: Breast Cancer

MYL-1401O is a proposed biosimilar to branded trastuzumab (Herceptin), indicated for the treatment of certain HER2-positive breast cancers.

metadoxine

Company: Alcobra Ltd.
Treatment for: Attention Deficit Disorder

Metadoxine is an ion-pair salt of pyridoxine (vitamin B6) in development for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD).

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.

ADS-5102 (amantadine hydrochloride) Extended-Release Capsules

Company: Adamas Pharmaceuticals, Inc.
Treatment for: Parkinson's Disease

ADS-5102 (amantadine hydrochloride) is a chrono-synchronous amantadine therapy for the potential treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson's disease.

Duzallo (allopurinol and lesinurad)

Company: Ironwood Pharmaceuticals, Inc.

Duzallo (allopurinol and lesinurad) is a xanthine oxidase inhibitor and URAT1 inhibitor fixed-dose combination in development for the treatment of hyperuricemia in patients with uncontrolled gout.

Solithera (solithromycin)

Company: Cempra, Inc.
Treatment for: Community Acquired Bacterial Pneumonia

Solithera (solithromycin) is a next-generation oral and intravenous fluoroketolide in clinical development for the treatment of moderate to moderately-severe community acquired bacterial pneumonia (CABP).

betrixaban

Company: Portola Pharmaceuticals Inc.
Treatment for: Venous Thromboembolism

Betrixaban is an oral, once-daily Factor Xa inhibitor anticoagulant in development for the extended-duration prophylaxis of venous thromboembolism (VTE) in acute medically ill patients with risk factors for VTE.

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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