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.
Macrilen (macimorelin acetate)
Company: Aeterna Zentaris Inc.
Treatment for: Adult Human Growth Hormone Deficiency
Macrilen (macimorelin) is a ghrelin agonist in development for use in evaluating adult growth hormone deficiency (AGHD).
- Aeterna Zentaris Announces Plans to Pursue FDA Registration of Macrilen - February 13, 2017
- Aeterna Zentaris Completes Patient Recruitment for Confirmatory Phase 3 Trial of Macrilen - October 26, 2016
- Aeterna Zentaris Announces Plans to Initiate Phase 3 Study of Macrilen in AGHD - April 13, 2015
- FDA Issues Complete Response Letter for Macrilen (macimorelin) NDA in Adult Growth Hormone Deficiency - November 6, 2014
- Aeterna Zentaris NDA for Macimorelin Acetate in AGHD Accepted for Filing by the FDA - January 6, 2014
- Aeterna Zentaris Submits New Drug Application to FDA for Macimorelin Acetate (AEZS-130) for Evaluation of AGHD - November 5, 2013
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.
- Flexion Therapeutics Announces NDA for Zilretta (FX006) Accepted by U.S. FDA - February 7, 2017
- Flexion Therapeutics Submits New Drug Application for Zilretta to Treat Knee Osteoarthritis Pain - December 12, 2016
- Flexion Therapeutics Receives Positive Guidance from FDA on NDA Submission for Zilretta for Osteoarthritis of the Knee - May 26, 2016
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).
- Charleston Laboratories, Inc. and Daiichi Sankyo, Inc. Receive Complete Response Letter from FDA for NDA for CL-108 (hydrocodone, acetaminophen, promethazine) Tablets - February 3, 2017
- Charleston Laboratories, Inc. and Daiichi Sankyo, Inc. Announce FDA Acceptance of New Drug Application (NDA) for CL-108 - June 13, 2016
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.
- U.S. FDA Grants Priority Review to AbbVie for its Investigational Regimen of Glecaprevir/Pibrentasvir (G/P) for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT1-6) - February 2, 2017
- AbbVie Submits NDA to FDA for its Investigational Regimen of Glecaprevir/Pibrentasvir (G/P) for the Treatment of All Major Genotypes of Chronic Hepatitis C - December 19, 2016
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.
- Intellipharmaceutics Announces FDA Acceptance for Filing of NDA for Rexista (oxycodone hydrochloride extended release) Abuse Deterrent Opioid Analgesic - February 2, 2017
- Intellipharmaceutics Submits NDA for Rexista (oxycodone hydrochloride extended release), an Abuse Deterrent Opioid Analgesic for the Treatment of Moderate to Severe Pain - November 25, 2016
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.
- Ocular Therapeutix Resubmits NDA for Dextenza for the Treatment of Ocular Pain Occurring After Ophthalmic Surgery - January 23, 2017
- Ocular Therapeutix Receives Complete Response Letter from FDA for its NDA for Dextenza for the Treatment of Post-Surgical Ocular Pain - July 25, 2016
- Ocular Therapeutix Announces FDA Acceptance of NDA Filing for Dextenza for the Treatment of Post-Surgical Ocular Pain - December 9, 2015
- Ocular Therapeutix Submits NDA for Dextenza for the Treatment of Post-Surgical Ocular Pain - September 28, 2015
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).
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.
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.
- 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
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.
Company: Neurocrine Biosciences, Inc.
Treatment for: Tardive Dyskinesia
Ingrezza (valbenazine) is a novel, highly-selective VMAT2 inhibitor in development for the treatment of tardive dyskinesia.
- Neurocrine Provides Update on FDA Advisory Committee for Ingrezza (valbenazine) for the Treatment of Tardive Dyskinesia - January 5, 2017
- Neurocrine Announces FDA Advisory Committee Meeting to Review Ingrezza (valbenazine) NDA for the Treatment of Tardive Dyskinesia - November 29, 2016
- Neurocrine Announces Ingrezza (valbenazine) NDA for the Treatment of Tardive Dyskinesia has been Accepted for Priority Review by FDA - October 11, 2016
- Neurocrine Announces FDA Conditional Acceptance of Proprietary Name Ingrezza for VMAT2 Inhibitor Valbenazine - August 31, 2016
- Neurocrine Submits New Drug Application for Valbenazine for Treatment of Tardive Dyskinesia - August 29, 2016
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.
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).
- Cempra Receives Complete Response Letter From FDA For Solithromycin NDAs - December 29, 2016
- FDA Advisory Committee Votes That Efficacy Results of Cempra's Solithromycin Outweigh Risks for Community-Acquired Bacterial Pneumonia - November 4, 2016
- Cempra Announces FDA Acceptance of Solithera New Drug Applications in the Treatment of Community-Acquired Bacterial Pneumonia - July 5, 2016
- Cempra Completes NDA Submissions for Solithromycin in the Treatment of Community-Acquired Bacterial Pneumonia - May 1, 2016
- FDA Grants Fast Track Designation to Cempra for Solithromycin in the Treatment of Community Acquired Bacterial Pneumonia - August 19, 2015
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.
- Portola Pharmaceuticals Announces FDA Accepts NDA for Priority Review for Oral, Factor Xa Inhibitor Anticoagulant Betrixaban - December 23, 2016
- Portola Pharmaceuticals Submits NDA to U.S. FDA for Betrixaban for Extended Duration Prophylaxis of Venous Thromboembolism in Acute Medically Ill Patients - October 25, 2016