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.

lasmiditan

Company: Eli Lilly and Company
Treatment for: Migraine

Lasmiditan is an investigational selective serotonin 5-HT1F agonist in development for the acute treatment of migraine with or without aura in adults.

Lilly Submits New Drug Application to the FDA for Lasmiditan for Acute Treatment of Migraine - November 14, 2018

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.

Trevena Receives Complete Response Letter for Oliceridine from FDA - November 2, 2018
Trevena Announces Oliceridine FDA Advisory Committee Meeting Outcome - October 11, 2018
Trevena Announces FDA Acceptance for Review of New Drug Application for Olinvo (oliceridine) Injection - January 2, 2018
Trevena Announces Submission of New Drug Application to U.S. FDA for Olinvo (oliceridine injection) - November 2, 2017

Zulresso (brexanolone)

Company: Sage Therapeutics
Treatment for: Postpartum Depression

Zulresso (brexanolone) is an allosteric modulator of both synaptic and extrasynaptic GABA_A receptors in development for the treatment of postpartum depression (PPD).

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.

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.

Heron Announces FDA Submission of HTX-011 NDA for Postoperative Pain Management - October 31, 2018

Dengvaxia (dengue vaccine)

Company: Sanofi Pasteur
Treatment for: Prevention of Dengue

Dengvaxia (dengue vaccine) is a live recombinant tetravalent dengue vaccine in development for the prevention of dengue.

FDA Grants Priority Review for Sanofi's Dengue Vaccine Candidate - October 30, 2018

Edsivo (celiprolol)

Company: Acer Therapeutics Inc.
Treatment for: Vascular Ehlers-Danlos Syndrome

Edsivo (celiprolol) is a β-blocker (β1-andrenoceptor antagonist with partial β2 agonist activity) in development for the treatment of vascular Ehlers-Danlos syndrome (vEDS).

Acer Therapeutics Submits NDA for Edsivo (celiprolol) for the Treatment of Vascular Ehlers-Danlos syndrome (vEDS) - October 29, 2018

dolutegravir and lamivudine Tablets

Company: ViiV Healthcare
Treatment for: HIV Infection

Dolutegravir and lamivudine is an investigational two-drug regimen of the approved drugs dolutegravir (Tivicay) and lamivudine (Epivir) in development for the treatment of HIV-1 infection.

ViiV Healthcare Submits New Drug Application to FDA for Single-Tablet, Two-Drug Regimen of Dolutegravir and Lamivudine for Treatment of HIV - October 18, 2018

prucalopride

Company: Shire plc
Treatment for: Chronic Idiopathic Constipation

Prucalopride is a selective serotonin type 4 (5‑HT4) receptor agonist in development for the treatment of chronic idiopathic constipation (CIC) in adults.

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.

Kala Pharmaceuticals Submits New Drug Application to U.S. Food and Drug Administration for KPI-121 0.25% for Dry Eye Disease - October 16, 2018

Dsuvia (sufentanil) Sublingual Tablets

Company: AcelRx Pharmaceuticals, Inc.
Treatment for: Pain

Dsuvia (sufentanil) is a synthetic opioid analgesic formulation for the management of acute pain that is severe enough to require an opioid analgesic, and for which alternative treatments are inadequate.

FDA Approves Dsuvia (sufentanil) Sublingual Tablets for Severe Pain - November 2, 2018
FDA Advisory Committee Recommends Approval of Dsuvia for the Treatment of Moderate-to-Severe Acute Pain - October 12, 2018
AcelRx Announces FDA Acceptance of NDA for DSUVIA - May 24, 2018
AcelRx Resubmits New Drug Application for DSUVIA - May 9, 2018
AcelRx Announces Receipt of Type A FDA Meeting Minutes and Plans to Resubmit the DSUVIA New Drug Application in Q2 2018 - March 8, 2018
AcelRx Pharmaceuticals Receives Complete Response Letter from the FDA for DSUVIA NDA - October 12, 2017
AcelRx Pharmaceuticals' New Drug Application for DSUVIA Accepted for Filing - February 27, 2017
AcelRx Pharmaceuticals Provides Guidance on 2017 Milestones for ARX-04, now known as DSUVIA in the United States, for the Treatment of Moderate-to-Severe Acute Pain - January 8, 2017
AcelRx Pharmaceuticals Submits New Drug Application for ARX-04 for the Treatment of Moderate-To-Severe Acute Pain - December 13, 2016

Bryhali (halobetasol propionate) Lotion - formerly Jemdel

Company: Ortho Dermatologics
Treatment for: Plaque Psoriasis

Bryhali (halobetasol propionate) is a high-potency topical corticosteroid formulation for the treatment of plaque psoriasis in adults.

siponimod

Company: Novartis
Treatment for: Multiple Sclerosis

Siponimod is an investigational, sphingosine-1-phosphate receptor modulator in development for the treatment of secondary progressive multiple sclerosis.

Novartis Announces FDA and EMA Filing Acceptance of Siponimod for Secondary Progressive Multiple Sclerosis (SPMS) - October 8, 2018

Barhemsys (amisulpride) Injection - formerly Baremsis

Company: Acacia Pharma
Treatment for: Nausea/Vomiting -- Postoperative

Barhemsys (amisulpride) is a dopamine antagonist in development for the management of post-operative nausea & vomiting (PONV).

FDA Issues a Complete Response Letter to Acacia Pharma for Barhemsys - October 8, 2018
Acacia Pharma Announces FDA Acceptance of NDA Filing For Baremsis for the Management of Post-Operative Nausea & Vomiting - January 4, 2018

selinexor

Company: Karyopharm Therapeutics Inc.
Treatment for: Multiple Myeloma

Selinexor (KPT-330) is a first in class Selective Inhibitor of Nuclear Export (SINE) XPO1 antagonist in development for the treatment of patients with penta-refractory multiple myeloma.

Feraccru (ferric maltol)

Company: Shield Therapeutics plc
Treatment for: Iron Deficiency

Feraccru (ferric maltol) is a non-salt formulation of ferric iron in development for the treatment of iron deficiency.

Shield Therapeutics Announces Submission of a New Drug Application (NDA) for Feraccru for the treatment of Iron Deficiency - October 1, 2018

lumateperone

Company: Intra-Cellular Therapies, Inc.
Treatment for: Schizophrenia

Lumateperone is first-in-class antipsychotic in development for the treatment of schizophrenia.

Valtoco (diazepam) Nasal Spray

Company: Neurelis, Inc.
Treatment for: Epilepsy

Valtoco (diazepam) is an investigational benzodiazepine nasal spray formulation in development for the treatment of epilepsy cluster seizures.

erdafitinib

Company: Janssen Pharmaceuticals, Inc.
Treatment for: Urothelial Carcinoma

Erdafitinib is an investigational, once-daily oral pan-fibroblast growth factor receptor (FGFR) in development for the treatment of patients with locally advanced or metastatic urothelial cancer.

Janssen Submits New Drug Application to U.S. FDA Seeking Approval of Erdafitinib for the Treatment of Metastatic Urothelial Cancer - September 18, 2018

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