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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: 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).


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.


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).


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.

SequestOx (naltrexone and oxycodone hydrochloride)

Company: Elite Pharmaceuticals, Inc.
Treatment for: Pain

SequestOx (oxycodone hydrochloride and naltrexone) is an abuse-deterrent opioid formulation in development for the management of moderate to severe pain.

Lutathera (lutetium Lu 177 dotatate)

Company: Advanced Accelerator Applications S.A.
Treatment for: Neuroendocrine Carcinoma

Lutathera (lutetium Lu 177 dotatate) is a Lu-177-labeled somatostatin analogue peptide in development for the treatment of gastroenteropancreatic neuroendocrine tumors.


Company: Tesaro, Inc.
Treatment for: Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

Niraparib is an oral, poly ADP-ribose polymerase (PARP) inhibitor in development for the treatment of patients with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer.

Cotempla XR-ODT (methylphenidate) Extended-Release Orally Disintegrating Tablets

Company: Neos Therapeutics, Inc.
Treatment for: Attention-Deficit/Hyperactivity Disorder (ADHD)

Cotempla XR-ODT (methylphenidate) is a once-daily, extended-release, orally disintegrating tablet formulation of the stimulant methylphenidate, in development for the treatment of attention-deficit/hyperactivity disorder (ADHD).

Ocrevus (ocrelizumab)

Company: Genentech, Inc.
Treatment for: Multiple Sclerosis

Ocrevus (ocrelizumab) is a humanized monoclonal antibody designed to target CD20-positive B-cells, which are implicated in the inflammatory and neurodegenerative processes of multiple sclerosis. Ocrevus is an investigational treatment for both relapsing (RMS) and primary progressive (PPMS) forms of multiple sclerosis.

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.

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

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