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.
Tofersen
Company: Biogen Inc.
Treatment for: Amyotrophic Lateral Sclerosis
Tofersen is an antisense drug in development for the treatment of superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS).
- Biogen Provides Update on FDA Advisory Committee Meeting on Tofersen for SOD1-ALS - March 23, 2023
- Biogen Announces FDA’s 3-Month Extension of Review Period for the New Drug Application for Tofersen - October 17, 2022
- FDA Accepts Biogen’s New Drug Application and Grants Priority Review of Tofersen for a Rare, Genetic Form of ALS - July 26, 2022
ABBV-951 (foscarbidopa and foslevodopa)
Company: AbbVie Inc.
Treatment for: Parkinson's Disease
ABBV-951 (foscarbidopa/foslevodopa) is a solution of carbidopa and levodopa prodrugs for continuous subcutaneous delivery that is being investigated for the treatment of motor fluctuations in patients with advanced Parkinson's disease.
Eplontersen
Company: Ionis Pharmaceuticals
Treatment for: Hereditary Transthyretin-Mediated Amyloid Polyneuropathy (ATTRv-PN)
Eplontersen is a LIgand-Conjugated Antisense (LICA) medicine in development for the treatment of hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN).
Lumryz (sodium oxybate) - formerly FT218
Company: Avadel Pharmaceuticals plc
Treatment for: Narcolepsy
Lumryz (sodium oxybate) is a once-nightly formulation of the approved central nervous system depressant sodium oxybate in development for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy.
- Avadel Pharmaceuticals Requests Final FDA Approval for Lumryz (sodium oxybate) Extended-Release Oral Suspension - March 2, 2023
- Avadel Pharmaceuticals Announces Tentative Approval of Lumryz (sodium oxybate) Extended-Release Oral Suspension - July 19, 2022
- Avadel Pharmaceuticals Announces FDA Acceptance of New Drug Application for FT218 in Adults with Narcolepsy for the Treatment of Excessive Daytime Sleepiness and Cataplexy - March 1, 2021
ADX-2191 (methotrexate)
Company: Aldeyra Therapeutics, Inc.
Treatment for: Primary Vitreoretinal Lymphoma
ADX-2191 (methotrexate) is an intravitreal formulation of the folate analog metabolic inhibitor methotrexate in development for the treatment of primary vitreoretinal lymphoma.
- FDA Accepts for Priority Review ADX-2191 New Drug Application for the Treatment of Primary Vitreoretinal Lymphoma - March 2, 2023
- Aldeyra Therapeutics Submits New Drug Application to the U.S. Food and Drug Administration for ADX‑2191 for the Treatment of Primary Vitreoretinal Lymphoma - December 21, 2022
Omecamtiv mecarbil
Company: Cytokinetics, Inc.
Treatment for: Heart Failure with Reduced Ejection Fraction
Omecamtiv mecarbil is a first in class, small molecule cardiac myosin activator in development for the treatment of heart failure with reduced ejection fraction (HFrEF).
- Cytokinetics Receives Complete Response Letter From FDA for New Drug Application for Omecamtiv Mecarbil - February 28, 2023
- Cytokinetics Announces Outcome of FDA Advisory Committee Vote On Omecamtiv Mecarbil - December 13, 2022
- Cytokinetics Provides Regulatory Update Related to New Drug Application for Omecamtiv Mecarbil - May 17, 2022
- Cytokinetics Announces FDA Acceptance of New Drug Application for Omecamtiv Mecarbil for the Treatment of Heart Failure With Reduced Ejection Fraction - February 4, 2022
VP-102 (cantharidin) Topical Solution
Company: Verrica Pharmaceuticals Inc.
Treatment for: Molluscum Contagiosum
VP-102 (cantharidin) is a topical terpenoid in development for the treatment of molluscum contagiosum.
- Verrica Pharmaceuticals Announces FDA Acceptance of Filing of Resubmitted NDA for VP-102 for the Treatment of Molluscum Contagiosum - February 27, 2023
- Verrica Pharmaceuticals Announces Resubmission of New Drug Application for VP-102 for the Treatment of Molluscum Contagiosum - January 24, 2023
- Verrica Receives Complete Response Letter from the FDA for its NDA for VP-102 - May 24, 2022
- Verrica Pharmaceuticals Announces Resubmission of New Drug Application for VP-102 for the Treatment of Molluscum Contagiosum - November 29, 2021
- Verrica Pharmaceuticals Receives Complete Response Letter from the FDA identifying deficiencies at a facility of a Contract Manufacturer for its New Drug Application for VP-102 for the Treatment of Molluscum Contagiosum - September 20, 2021
- Verrica Pharmaceuticals Announces Extension of FDA Review Period of its NDA for VP-102 for the Treatment of Molluscum Contagiosum - May 28, 2021
- Verrica Pharmaceuticals Announces Resubmission of New Drug Application for VP-102 for the Treatment of Molluscum Contagiosum - December 23, 2020
- Verrica Pharmaceuticals Announces Resubmission of New Drug Application for VP-102 for the Treatment of Molluscum Contagiosum - December 23, 2020
- Verrica Pharmaceuticals Receives Complete Response Letter from the FDA for its New Drug Application for VP-102 for the Treatment of Molluscum Contagiosum - July 14, 2020
- Verrica Pharmaceuticals Provides Regulatory Update on VP-102 - June 29, 2020
- Verrica Pharmaceuticals Announces FDA Filing Acceptance of New Drug Application for VP-102 for the Treatment of Molluscum Contagiosum - November 27, 2019
- Verrica Pharmaceuticals Submits New Drug Application to U.S. Food and Drug Administration for VP-102 for the Treatment of Molluscum Contagiosum - September 16, 2019
Elranatamab
Company: Pfizer Inc.
Elranatamab is a B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody (BsAb) in development for the treatment of patients with relapsed or refractory multiple myeloma.
- Pfizer’s Elranatamab Receives FDA and EMA Filing Acceptance - February 22, 2023
Pozelimab
Company: Regeneron Pharmaceuticals, Inc.
Treatment for: CHAPLE
Pozelimab is a complement C5 inhibitor in development for the treatment of adults and children with CHAPLE disease.
CSF-1 (pilocarpine hydrochloride) Ophthalmic Solution
Company: Orasis Pharmaceuticals
Treatment for: Presbyopia
CSF-1 (pilocarpine) is a low dose ophthalmic formulation of the approved muscarinic cholinergic agonist pilocarpine in development to improve near vision for people with presbyopia.
Fezolinetant
Company: Astellas Pharma Inc.
Treatment for: Menopausal Disorders, Hot Flashes
Fezolinetant is a selective neurokinin 3 (NK3) receptor antagonist in development for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.
- Astellas Provides Update on Fezolinetant New Drug Application in U.S. - February 20, 2023
- U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant - August 18, 2022
- Astellas Submits Fezolinetant New Drug Application to U.S. FDA - June 23, 2022
Nyxol (phentolamine mesylate) Ophthalmic Solution
Company: Ocuphire Pharma, Inc.
Treatment for: Reversal of Pharmacologically Induced Mydriasis
Nyxol (phentolamine mesylate) is a nonselective alpha adrenergic antagonist ophthalmic formulation in development for the reversal of pharmacologically-induced mydriasis.
ATI-1501 (metronidazole)
Company: Appili Therapeutics Inc. and Saptalis Pharmaceuticals LLC
Treatment for: Bacterial Infection
ATI-1501 (metronidazole) is a liquid suspension formulation of the approved antibiotic metronidazole in development for the treatment of parasitic and anaerobic bacterial infections.
- Appili Therapeutics Announces that FDA accepts the ATI-1501 NDA - February 8, 2023
Reproxalap
Company: Aldeyra Therapeutics, Inc.
Treatment for: Dry Eye Disease
Reproxalap is a first-in-class small-molecule modulator of RASP (reactive aldehyde species) in development for the treatment of signs and symptoms of dry eye disease.
- Aldeyra Therapeutics Announces FDA Acceptance of New Drug Application for Reproxalap for the Treatment of Dry Eye Disease - February 7, 2023
- Aldeyra Therapeutics Submits New Drug Application to the U.S. Food and Drug Administration for Reproxalap for the Treatment of Signs and Symptoms of Dry Eye Disease - November 29, 2022
Zuranolone
Company: Sage Therapeutics, Inc.
Treatment for: Major Depressive Disorder, Postpartum Depression
Zuranolone is an investigational oral neuroactive steroid (NAS) GABA-A receptor positive allosteric modulator (PAM) in development for the treatment of major depressive disorder (MDD) and postpartum depression (PPD).
- Biogen and Sage Therapeutics Announce FDA Accepts Filing of New Drug Application and Grants Priority Review of Zuranolone in the Treatment of Major Depressive Disorder and Postpartum Depression - February 6, 2023
- Biogen and Sage Therapeutics Complete Rolling Submission of New Drug Application for Zuranolone in the Treatment of Major Depressive Disorder and Postpartum Depression - December 6, 2022
- Sage Therapeutics and Biogen Initiate Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration for Zuranolone for the Potential Treatment of Major Depressive Disorder (MDD) - May 2, 2022
OX124 (naloxone)
Company: Orexo AB
Treatment for: Opioid Overdose
OX124 (naloxone) is a high-dose nasal formulation of the approved opioid antagonist naloxone in development as a rescue medication for opioid overdose.
Rezzayo (rezafungin) Powder for Injection
Company: Cidara Therapeutics, Inc.
Treatment for: Candidemia, Systemic Candidiasis
Rezzayo (rezafungin) is an echinocandin antifungal used for the treatment of candidemia and invasive candidiasis.
- FDA Approves Rezzayo (rezafungin for injection) for the Treatment of Candidemia and Invasive Candidiasis - March 23, 2023
- Cidara Therapeutics and Melinta Therapeutics Announce FDA Advisory Committee Recommends Approval of Rezafungin for the Treatment of Candidemia and Invasive Candidiasis - January 25, 2023
- Cidara Therapeutics Announces FDA Acceptance for Priority Review of New Drug Application for Rezafungin for the Treatment of Candidemia and Invasive Candidiasis - September 20, 2022
- Cidara Therapeutics Submits NDA for Rezafungin - July 27, 2022
Exxua (gepirone) - formerly Travivo
Company: Fabre-Kramer Pharmaceuticals Inc.
Treatment for: Depression
Exxua (gepirone) is an investigational azapirone antidepressant in development for the treatment of adults with major depressive disorder.
- Fabre-Kramer Pharmaceuticals Announces FDA Acceptance of NDA Resubmission as Complete Response and Assignment of PDUFA Regulatory Action Date - January 24, 2023
- Fabre-Kramer Submits NDA Amendment for Exxua™ for Treatment of Major Depressive Disorder - January 4, 2023
- FDA Rules Favorably On Efficacy Of Travivo (Gepirone ER) For Treatment Of Major Depressive Disorder - March 17, 2016
- Fabre-Kramer Looks Forward to FDA's Decision on Gepirone ER for the Treatment of Major Depressive Disorder - December 2, 2015
- Fabre Kramer Pharmaceuticals Receives Decision From FDA on Gepirone ER for Major Depressive Disorder - November 5, 2007
- Fabre-Kramer Refiles Gepirone ER with the FDA for the Treatment of Major Depressive Disorder - May 8, 2007
Vamorolone
Company: Santhera Pharmaceuticals and ReveraGen BioPharma, Inc.
Treatment for: Duchenne Muscular Dystrophy
Vamorolone is a first-in-class steroidal anti-inflammatory in development for the treatment of Duchenne muscular dystrophy (DMD).
- Santhera and ReveraGen Announce FDA Acceptance of New Drug Application for Vamorolone in Duchenne Muscular Dystrophy - January 9, 2023
- Santhera and ReveraGen Complete NDA Submission to FDA for Vamorolone in Duchenne Muscular Dystrophy - October 27, 2022
- Santhera and ReveraGen Start Rolling NDA Submission to the FDA for Vamorolone for the Treatment of Duchenne Muscular Dystrophy - March 29, 2022
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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