New Drug Applications Archive for 2021

January 4, 2021

• Provention Bio Announces U.S. FDA Filing of a Biologics License Application (BLA) and Priority Review for Teplizumab for the Delay or Prevention of Clinical Type 1 Diabetes in At-risk Individuals
• US FDA Accepts Regulatory Submission from Pfizer and OPKO for Review of Somatrogon to Treat Pediatric Patients with Growth Hormone Deficiency

January 5, 2021

• Marius Pharmaceuticals Submits New Drug Application to U.S. FDA for Kyzatrex Next-generation Oral Testosterone Replacement Therapy in Male Patients with Hypogonadism

January 19, 2021

• Biologics License Application for Narsoplimab in HSCT-TMA Accepted for Priority Review by U.S. FDA

January 20, 2021

• Impel NeuroPharma Announces U.S. Food & Drug Administration Acceptance of New Drug Application for INP104 for the Acute Treatment of Migraine

January 25, 2021

• Albireo Announces U.S. FDA Acceptance of New Drug Application for Odevixibat
• Iterum Therapeutics Announces U.S. FDA Filing Acceptance of New Drug Application for Oral Sulopenem

January 29, 2021

• Biogen and Eisai Announce FDA’s 3-Month Extension of Review Period for the Biologics License Application for Aducanumab

February 1, 2021

• Mirum Pharmaceuticals Announces Completion of Rolling NDA Submission for Maralixibat in Alagille Syndrome

February 8, 2021

• Supernus Resubmits New Drug Application for SPN-812 for the Treatment of ADHD in Pediatric Patients

February 10, 2021

• Genmab and Seagen Submit Tisotumab Vedotin Biologics License Application to the U.S. FDA for Patients with Recurrent or Metastatic Cervical Cancer

February 16, 2021

• Sesen Bio Announces FDA Acceptance and Priority Review of its Biologics License Application for Vicineum

February 19, 2021

• Incyte Announces Acceptance and Priority Review of NDA for Ruxolitinib Cream for Atopic Dermatitis

February 22, 2021

• Noven Submits New Drug Application for Investigational Dextroamphetamine Transdermal System for ADHD

February 25, 2021

• Allergan Submits New Drug Application for Investigational AGN-190584 for the Treatment of Presbyopia

March 1, 2021

• Avadel Pharmaceuticals Announces FDA Acceptance of New Drug Application for FT218 in Adults with Narcolepsy for the Treatment of Excessive Daytime Sleepiness and Cataplexy
• Reata Pharmaceuticals, Inc. Submits NDA for Company’s Lead Program: Bardoxolone in Alport Syndrome
• U.S. FDA Accepts Merck’s Gefapixant New Drug Application for Review

March 2, 2021

• Eyenovia Announces FDA Acceptance of the MydCombi NDA
• Strongbridge Biopharma plc Announces Submission of New Drug Application for Recorlev (levoketoconazole) for the Treatment of Endogenous Cushing’s Syndrome to the FDA
• Oyster Point Pharma Announces FDA Acceptance for Filing New Drug Application for OC-01 (varenicline) Nasal Spray for the Treatment of Signs and Symptoms of Dry Eye Disease

March 8, 2021

• Vifor Pharma and Cara Therapeutics Announce U.S. FDA Acceptance and Priority Review of NDA for Korsuva Injection in Hemodialysis Patients With Moderate-to-Severe Pruritus

March 10, 2021

• Kadmon Announces U.S. FDA Has Extended the Review Period for Belumosudil in Chronic Graft-Versus-Host Disease
• FDA Accepts the New Drug Application for Review of Idorsia’s Daridorexant for the Treatment of Adult Patients with Insomnia

March 11, 2021

• Marius Pharmaceuticals Receives PDUFA Date for Kyzatrex NDA for Treatment of Hypogonadism
• BioXcel Therapeutics Submits New Drug Application to U.S. Food and Drug Administration for BXCL501 for the Acute Treatment of Agitation Associated with Schizophrenia and Bipolar Disorders

March 15, 2021

• Calliditas Announces Submission of New Drug Application to U.S. FDA for Nefecon in Patients with Primary IgA Nephropathy

March 16, 2021

• Merck Receives Priority Review From FDA for New Drug Application for HIF-2α Inhibitor Belzutifan (MK-6482)

March 19, 2021

• U.S. Food and Drug Administration (FDA) Accepts Bristol Myers Squibb’s Application for Mavacamten in Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)

March 25, 2021

• Joint FDA Advisory Committee Votes on Application for Tanezumab for the Treatment of Osteoarthritis Pain

March 28, 2021

• Mezzion Announces Re-Submission of New Drug Application for its Orphan Drug Udenafil to Treat Patients who have undergone the Fontan Operation for Single Ventricle Heart Disease

March 29, 2021

• TG Therapeutics Completes Rolling Submission of Biologics License Application to the U.S. Food and Drug Administration for Ublituximab in Combination with Ukoniq (umbralisib) as a Treatment for Patients with Chronic Lymphocytic Leukemia
• Mirum Pharmaceuticals Announces FDA Acceptance of New Drug Application and Priority Review for Maralixibat in Alagille Syndrome

March 30, 2021

• U.S. FDA Accepts AbbVie's New Drug Application for Atogepant for the Preventive Treatment of Migraine
• Akebia Submits New Drug Application (NDA) to the FDA for Vadadustat for the Treatment of Anemia Due to Chronic Kidney Disease in Adult Patients on Dialysis and Not on Dialysis

March 31, 2021

• Evive Biotech Submits Biologics License Application to US FDA for Ryzneuta
• CTI BioPharma Announces Completion of Rolling Submission of New Drug Application (NDA) for Pacritinib in Myelofibrosis Patients with Severe Thrombocytopenia

April 7, 2021

• Pfizer Announces Extension of Review of New Drug Application of Abrocitinib for the Treatment of Moderate to Severe Atopic Dermatitis

April 9, 2021

• Genmab and Seagen Announce U.S. FDA Filing Acceptance for Priority Review of Tisotumab Vedotin Biologics License Application for Patients with Recurrent or Metastatic Cervical Cancer

April 26, 2021

• Axsome Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for AXS-05 for Treatment of Major Depressive Disorder
• Reata Announces FDA Accepted for Filing the NDA for Bardoxolone for the Treatment of Patients With Chronic Kidney Disease Caused by Alport Syndrome

April 27, 2021

• Takeda Announces U.S. FDA Grants Priority Review for New Drug Application for Mobocertinib (TAK-788) as a Treatment for EGFR Exon20 Insertion+ Metastatic Non-Small Cell Lung Cancer

May 3, 2021

• Clearside Biomedical Announces Resubmission of New Drug Application for Xipere for Treatment of Macular Edema Associated with Uveitis

May 10, 2021

• Liquidia Resubmits New Drug Application for LIQ861 (treprostinil) Inhalation Powder for the Treatment of Pulmonary Arterial Hypertension
• Amgen Announces Tezepelumab Biologics License Application Submitted To U.S. FDA

May 13, 2021

• Strongbridge Biopharma plc Announces U.S. Food & Drug Administration (FDA) Filing Acceptance of New Drug Application (NDA) for Recorlev (levoketoconazole) for the Treatment of Endogenous Cushing’s Syndrome

May 17, 2021

• Adamis Pharmaceuticals Resubmits Zimhi New Drug Application to FDA for the Treatment of Opioid Overdose

May 18, 2021

• U.S. FDA Accepts Regulatory Submission for Sintilimab in Combination with Pemetrexed and Platinum Chemotherapy for the First-Line Treatment of People with Nonsquamous Non-Small Cell Lung Cancer

May 19, 2021

• BioXcel Therapeutics Announces FDA Acceptance for Filing of NDA for BXCL501 for the Acute Treatment of Agitation Associated with Schizophrenia and Bipolar Disorders I and II

May 20, 2021

• Omeros Announces Extension of FDA Review Period for Narsoplimab in HSCT-TMA

May 25, 2021

• TG Therapeutics Announces FDA Acceptance of Biologics License Application for Ublituximab in Combination with Ukoniq (umbralisib) as a Treatment for Patients with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

May 28, 2021

• Fennec Pharmaceuticals Resubmits New Drug Application To U.S. Food And Drug Administration For Pedmark
• Verrica Pharmaceuticals Announces Extension of FDA Review Period of its NDA for VP-102 for the Treatment of Molluscum Contagiosum
• Ipsen Confirms U.S. FDA Accepts New Drug Application for Palovarotene as the First Potential Treatment Worldwide for Fibrodysplasia Ossificans Progressiva (FOP)

June 1, 2021

• Mycovia Pharmaceuticals Submits New Drug Application to the U.S. FDA for Oteseconazole for the Treatment of Recurrent Vulvovaginal Candidiasis
• Akebia and Otsuka Announce FDA Acceptance for Filing of New Drug Application for Vadadustat for the Treatment of Anemia Due to Chronic Kidney Disease in Adult Patients on Dialysis and Not on Dialysis
• CTI BioPharma Announces Acceptance of NDA Granted with Priority Review of Pacritinib for Treatment of Patients with Myelofibrosis
• BeyondSpring Announces U.S. FDA Acceptance And Priority Review Of New Drug Application For Plinabulin And G-CSF Combination For The Prevention Of Chemotherapy-Induced Neutropenia (CIN)

June 3, 2021

• Dermavant Submits New Drug Application (NDA) to FDA for Tapinarof Cream for the Treatment of Adults with Plaque Psoriasis

June 9, 2021

• Adamis Provides Update on Zimhi

June 11, 2021

• Incyte Announces U.S. FDA Has Extended the New Drug Application Review Period for Ruxolitinib Cream for the Treatment of Atopic Dermatitis

June 18, 2021

• Orphazyme Provides Regulatory Update from FDA on Arimoclomol for Niemann-Pick Disease Type C

June 21, 2021

• Agios Submits New Drug Application to FDA for Mitapivat for Treatment of Adults with Pyruvate Kinase Deficiency

June 22, 2021

• Fennec Pharmaceuticals Announces FDA Acceptance of New Drug Application Resubmission for Pedmark

June 24, 2021

• Alnylam Announces U.S. Food and Drug Administration Acceptance of New Drug Application for Investigational Vutrisiran for the Treatment of the Polyneuropathy of Hereditary ATTR Amyloidosis
• Aquestive Therapeutics Resubmits New Drug Application for Libervant (diazepam) Buccal Film

June 28, 2021

• Gilead Submits New Drug Application to U.S. Food and Drug Administration for Lenacapavir, an Investigational, Long-Acting Capsid Inhibitor for the Treatment of HIV-1 in People With Limited Therapy Options

July 1, 2021

• U.S. FDA Accepts Filing of Hutchmed’s NDA for Surufatinib for the Treatment of Advanced Neuroendocrine Tumors

July 6, 2021

• Provention Bio Receives Complete Response Letter (CRL) to Biologics License Application (BLA) for Teplizumab for the Delay of Clinical Type 1 Diabetes (T1D) in At-Risk Individuals
• FDA Grants Priority Review for Levo Therapeutics’ New Drug Application for LV-101 (Intranasal Carbetocin) for the Treatment of Prader-Willi Syndrome

July 7, 2021

• Tezepelumab Granted Priority Review By U.S. FDA

July 16, 2021

• Status on FDA Advisory Committee Vote on Roxadustat in Anemia of Chronic Kidney Disease

July 19, 2021

• Aquestive Therapeutics Announces FDA Acceptance of New Drug Application (NDA) Resubmission for Libervant (diazepam) Buccal Film
• Ardelyx Provides Regulatory Update on New Drug Application for Tenapanor for the Control of Serum Phosphorus in Adult Patients with CKD on Dialysis

July 26, 2021

• FDA Accepts Braeburn’s New Drug Application Resubmission for Brixadi (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder

July 27, 2021

• Iterum Therapeutics Receives Complete Response Letter from U.S. Food and Drug Administration for Oral Sulopenem

July 28, 2021

• Mycovia Pharmaceuticals Announces U.S. FDA Acceptance and Priority Review of New Drug Application for Oteseconazole for the Treatment of Recurrent Vulvovaginal Candidiasis
• FDA Accepts Application for Genentech’s Faricimab for the Treatment of Wet Age-Related Macular Degeneration (AMD) and Diabetic Macular Edema (DME)

July 29, 2021

• Ardelyx Receives Complete Response Letter from U.S. FDA for New Drug Application for Tenapanor for the Control of Serum Phosphorus in Adult Patients with CKD on Dialysis

August 2, 2021

• GSK Files for Licensure of Priorix MMR Vaccine in the US

August 3, 2021

• Marinus Pharmaceuticals Submits New Drug Application (NDA) to FDA for Ganaxolone for the Treatment of Seizures Associated with CDKL5 Deficiency Disorder and Provides Pipeline Update

August 6, 2021

• Spectrum Pharmaceuticals Receives Complete Response Letter from FDA for Rolontis (eflapegrastim)

August 9, 2021

• Daré Bioscience Announces FDA Acceptance and Priority Review of New Drug Application for DARE-BV1 for the Treatment of Bacterial Vaginosis

August 10, 2021

• Dermavant Announces FDA Acceptance for Filing of New Drug Application (NDA) for Tapinarof Cream for the Treatment of Adults with Plaque Psoriasis

August 11, 2021

• FibroGen Receives Complete Response Letter from the FDA for Roxadustat for Anemia of Chronic Kidney Disease

August 13, 2021

• Ipsen Announces Withdrawal of Palovarotene NDA, Confirming Intention to Resubmit Following Additional Data Analyses
• Sesen Bio Receives Complete Response Letter from FDA for Vicineum (oportuzumab monatox-qqrs)

August 17, 2021

• Agios Announces FDA Acceptance and Priority Review of New Drug Application for Mitapivat for Treatment of Adults with Pyruvate Kinase Deficiency

August 23, 2021

• Axsome Therapeutics Provides Update on the New Drug Application for AXS-05 for the Treatment of Major Depressive Disorder

August 24, 2021

• Stealth BioTherapeutics Submits Elamipretide New Drug Application to FDA for Treatment of Barth Syndrome

August 25, 2021

• Pfizer and BioNTech Initiate Rolling Submission of Supplemental Biologics License Application to U.S. FDA for Booster Dose of Comirnaty in Individuals 16 and Older
• Moderna Completes Submission of Biologics License Application to the U.S. Food and Drug Administration for its COVID-19 Vaccine

September 1, 2021

• Coherus and Junshi Biosciences Announce Completion of Rolling BLA Submission to U.S. FDA for Toripalimab for the Treatment of Nasopharyngeal Carcinoma

September 14, 2021

• Axsome Therapeutics Announces FDA Acceptance of New Drug Application for AXS-07 for the Acute Treatment of Migraine

September 15, 2021

• ObsEva Announces Submission of New Drug Application to U.S. FDA for Linzagolix for the Treatment of Uterine Fibroids

September 20, 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
• U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Application for LAG-3-Blocking Antibody Relatlimab and Nivolumab Fixed-Dose Combination as Treatment for Patients with Unresectable or Metastatic Melanoma
• Marinus Pharmaceuticals Announces FDA Acceptance for Filing and Priority Review of New Drug Application for Ganaxolone in CDKL5 Deficiency Disorder

September 24, 2021

• Pfizer and OPKO Announce Extension of U.S. FDA Review of Biologics License Application of Somatrogon for Pediatric Growth Hormone Deficiency

September 27, 2021

• Eisai Initiates Rolling Submission to the U.S. FDA for Biologics License Application of Lecanemab (BAN2401) for Early Alzheimer's Disease Under the Accelerated Approval Pathway

September 28, 2021

• Lipocine Announces FDA Affirmation Of Class 1 NDA Resubmission For TLANDO®

October 1, 2021

• Omeros Provides Regulatory Update on Biologics License Application for Narsoplimab in the Treatment of HSCT-TMA

October 4, 2021

• Arcutis Submits Topical Roflumilast Cream New Drug Application to FDA for the Treatment of Adults and Adolescents with Plaque Psoriasis

October 18, 2021

• Omeros Receives Complete Response Letter from FDA for Biologics License Application for Narsoplimab in the Treatment of HSCT-TMA

October 28, 2021

• Spero Therapeutics Submits New Drug Application to U.S. FDA for Tebipenem HBr for the Treatment of Complicated Urinary Tract Infections including Pyelonephritis

November 1, 2021

• Hyloris Announces FDA Acceptance of New Drug Application for Maxigesic IV in Post-Operative Pain
• Incyte Announces Acceptance of NDA for Parsaclisib for Three Types of Relapsed or Refractory Non-Hodgkin Lymphomas

November 2, 2021

• Amylyx Pharmaceuticals Submits New Drug Application (NDA) for AMX0035 for the Treatment of ALS

November 8, 2021

• FDA Grants Tentative Approval for Liquidia’s Yutrepia (treprostinil) Inhalation Powder

November 18, 2021

• Heron Therapeutics Announces Submission of HTX-019 NDA for the Prevention of Postoperative Nausea and Vomiting to FDA

November 19, 2021

• Gilead Submits Biologics License Application to U.S. Food and Drug Administration for Bulevirtide, an Investigational Treatment for People Living With Chronic Hepatitis Delta

November 22, 2021

• Obseva Announces U.S. FDA Acceptance of New Drug Application for Linzagolix

November 23, 2021

• Amryt Provides Update on Regulatory Review Process for Oleogel-S10

November 29, 2021

• Verrica Pharmaceuticals Announces Resubmission of New Drug Application for VP-102 for the Treatment of Molluscum Contagiosum
• Fennec Pharmaceuticals Expects to Receive Complete Response Letter from the FDA for its New Drug Application for Pedmark™ to Prevent Ototoxicity Associated with Cisplatin in Pediatric Patients with Localized, Non-Metastatic, Solid Tumors

November 30, 2021

• Secura Bio Announces U.S. Withdrawal of Farydak (panobinostat) NDA

December 1, 2021

• BeyondSpring Pharmaceuticals Receives Complete Response Letter from the FDA for Plinabulin New Drug Application for Prevention of Chemotherapy-Induced Neutropenia (CIN)

December 3, 2021

• Secura Bio Announces Copiktra (duvelisib) Strategic Focus On T-cell Lymphoma And Voluntary U.S. Withdrawal Of The Relapsed Or Refractory Follicular Lymphoma Indication

December 6, 2021

• Spectrum Pharmaceuticals Submits New Drug Application for Poziotinib

December 8, 2021

• Reata Pharmaceuticals Announces Outcome of FDA Advisory Committee Meeting of Bardoxolone for the Treatment of Patients with Chronic Kidney Disease Caused by Alport Syndrome

December 15, 2021

• Braeburn Receives New Complete Response Letter for Brixadi in the US

December 16, 2021

• Pfizer and BioNTech Submit Supplemental Biologics License Application for U.S. FDA Approval of Comirnaty in Adolescents 12 Through 15 Years of Age

December 20, 2021

• Aquestive Therapeutics Receives Notification from FDA that It Will Not Be Ready to Take Action by December 23, 2021 for the Company’s NDA for Libervant (diazepam) Buccal Film

December 21, 2021

• Takeda Receives Complete Response Letter from the U.S. FDA for TAK-721

December 22, 2021

• Allarity Therapeutics Submits New Drug Application (NDA) to the U.S. FDA for Dovitinib for Third-Line Treatment of Renal Cell Carcinoma (RCC)
• FDA Accepts Arcutis Biotherapeutics’ New Drug Application for Roflumilast Cream for Adults and Adolescents with Plaque Psoriasis

December 29, 2021

• Amylyx Pharmaceuticals Announces FDA Acceptance and Priority Review of New Drug Application (NDA) for AMX0035 for the Treatment of ALS

December 30, 2021

• Lexicon Submits New Drug Application for Sotagliflozin for the Treatment of Heart Failure in Adults with Type 2 Diabetes