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.

lemborexant

Company: Eisai Co., Ltd.
Treatment for: Insomnia

Lemborexant is dual orexin receptor antagonist (DORA) in development for the treatment of insomnia.

New Drug Application for Insomnia Disorder Treatment Lemborexant Submitted in the United States - January 15, 2019

Vyndaqel (tafamidis meglumine)

Company: Pfizer Inc.
Treatment for: Transthyretin Familial Amyloid Polyneuropathy; Transthyretin Cardiomyopathy

Vyndaqel (tafamidis meglumine) is a transthyretin (TTR) dissociation inhibitor in development for the treatment of transthyretin familial amyloid polyneuropathy (TTR-FAP) and transthyretin cardiomyopathy (TTR-CM).

Contepo (fosfomycin)

Company: Nabriva Therapeutics plc

Contepo (fosfomycin for injection) is an investigational epoxide antibiotic in development as a first-line treatment for complicated urinary tract infections (cUTIs), including acute pyelonephritis.

HTX-011 (bupivacaine and meloxicam)

Company: Heron Therapeutics, Inc.
Treatment for: Postoperative Pain

HTX-011 (bupivacaine and meloxicam) is an investigational fixed-dose combination of the local anesthetic bupivacaine and the nonsteroidal anti-inflammatory drug (NSAID) meloxicam in development for the management of postoperative pain.

FDA Grants Priority Review Designation for Heron Therapeutics' NDA for HTX-011, a Non-Opioid for Postoperative Pain Management - December 31, 2018
Heron Announces FDA Submission of HTX-011 NDA for Postoperative Pain Management - October 31, 2018

KPI-121 0.25% (loteprednol etabonate)

Company: Kala Pharmaceuticals, Inc.
Treatment for: Dry Eye Disease

KPI-121 0.25% (loteprednol etabonate) is an ophthalmic corticosteroid formulation in development for the temporary relief of signs and symptoms of dry eye disease.

Brixadi (buprenorphine) Extended-Release Injection

Company: Braeburn Inc.
Treatment for: Opiate Dependence

Brixadi (buprenorphine) is a long-acting partial opioid agonist injection formulation in development for the treatment of opioid use disorder.

solriamfetol

Company: Jazz Pharmaceuticals plc
Treatment for: Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome

Solriamfetol is a selective dopamine and norepinephrine reuptake inhibitor (DNRI) in development for the treatment of excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea (OSA).

AR101 (peanut immunotherapy)

Company: Aimmune Therapeutics, Inc.
Treatment for: Peanut Allergy

AR101 is an investigational biologic oral immunotherapy for desensitization of patients with peanut allergy.

Aimmune Therapeutics Submits BLA to FDA for AR101 for the Treatment of Peanut Allergy in Children and Adolescents Ages 4–17 - December 21, 2018

FMX101 (minocycline) Foam

Company: Foamix Pharmaceuticals
Treatment for: Acne

FMX101 (minocycline) is a topical foam formulation of minocycline in development for the treatment of moderate-to-severe acne vulgaris.

Foamix Submits New Drug Application to U.S. FDA Seeking Approval of FMX101 in Treatment of Moderate-to-Severe Acne - December 21, 2018

Bronchitol (mannitol)

Company: Pharmaxis
Treatment for: Cystic Fibrosis

Bronchitol (mannitol) is an inhaled dry powder formulation of mannitol in development to improve lung function in patients with cystic fibrosis.

Pharmaxis Announces Resubmission of Bronchitol NDA - December 20, 2018

Pedmark (sodium thiosulfate)

Company: Fennec Pharmaceuticals Inc.
Treatment for: Prevention of Cisplatin-Induced Ototoxicity

Pedmark (sodium thiosulfate) is a cisplatin neutralizing agent in development for the protection against hearing loss in pediatric patients receiving cisplatin chemotherapy.

Fennec Pharmaceuticals Initiates Rolling New Drug Application to FDA for Pedmark - December 20, 2018

upadacitinib

Company: AbbVie Inc.
Treatment for: Rheumatoid Arthritis

Upadacitinib is a JAK1-selective inhibitor in development for the treatment of adult patients with moderate to severe rheumatoid arthritis.

AbbVie Submits New Drug Application to U.S. FDA for Upadacitinib for Treatment of Adults with Moderate to Severe Rheumatoid Arthritis - December 20, 2018

lefamulin

Company: Nabriva Therapeutics plc
Treatment for: Pneumonia

Lefamulin is a first-in-class, semi-synthetic pleuromutilin antibiotic in development for the treatment of community-acquired bacterial pneumonia (CABP).

Nabriva Therapeutics Submits New Drug Applications to U.S. Food and Drug Administration for Intravenous and Oral Lefamulin to Treat Community-Acquired Bacterial Pneumonia in Adults - December 20, 2018

golodirsen

Company: Sarepta Therapeutics, Inc.
Treatment for: Muscular Dystrophy

Golodirsen is a phosphordiamidate morpholino oligimer in development for the treatment of patients with Duchenne muscular dystrophy (DMD) who have genetic mutations subject to skipping exon 53 of the DMD gene.

Cosyntropin Depot

Company: Assertio Therapeutics, Inc.
Treatment for: Adrenocortical Insufficiency

Cosyntropin Depot is an alcohol-free, long-acting formulation of a synthetic ACTH analogue in development for use as a diagnostic in the screening of patients presumed to have adrenocortical insufficiency.

Assertio Therapeutics Announces Submission of NDA for FDA Approval of Cosyntropin Depot - December 20, 2018

Viaskin Peanut (peanut immunotherapy)

Company: DBV Technologies
Treatment for: Peanut Allergy

Viaskin Peanut is an immunotherapeutic skin patch in development for use in the treatment of peanut allergy.

Xipere (triamcinolone acetonide) Injection

Company: Clearside Biomedical, Inc.
Treatment for: Macular Edema, Uveitis

Xipere (triamcinolone acetonide) is a proprietary corticosteroid suspension for suprachoroidal injection in development for the treatment of macular edema associated with uveitis.

Clearside Biomedical Submits New Drug Application for Xipere for the Treatment of Macular Edema Associated with Uveitis - December 19, 2018

Vumerity (diroximel fumarate)

Company: Alkermes plc and Biogen Inc.
Treatment for: Multiple Sclerosis

Vumerity (diroximel fumarate) is a novel oral fumarate in development for the treatment of relapsing forms of multiple sclerosis (MS).

Alkermes and Biogen Announce Submission of a New Drug Application to U.S. Food and Drug Administration for Diroximel Fumarate in Multiple Sclerosis - December 17, 2018

UGN-101 (mitomycin) Gel

Company: UroGen Pharma Ltd.
Treatment for: Urothelial Carcinoma

UGN-101 (mitomycin gel) for instillation is an investigational drug formulation of mitomycin in development for the treatment for patients with low-grade upper tract urothelial cancer.

UroGen Pharma Initiates Rolling Submission of New Drug Application (NDA) for UGN-101 for the Treatment of Low-Grade Upper Tract Urothelial Cancer - December 17, 2018

ABP 710 (biosimilar infliximab)

Company: Amgen Inc.
Treatment for: Rheumatoid Arthritis, Plaque Psoriasis, Crohn's Disease -- Maintenance, Ulcerative Colitis, Psoriatic Arthritis, Ankylosing Spondylitis

ABP 710 (biosimilar infliximab) is a tumor necrosis factor (TNF) blocker biosimilar to Remicade (infliximab) in development for the treatment of rheumatoid arthritis, plaque psoriasis, Crohn's disease, ulcerative colitis, psoriatic arthritis, and ankylosing spondylitis.

Amgen Submits Biologics License Application for ABP 710 (Biosimilar Infliximab) To US Food And Drug Administration - December 17, 2018

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