New Drug Applications Archive for 2020

January 8, 2020

• Nabriva Therapeutics Receives FDA Acknowledgement of New Drug Application Resubmission for Intravenous Contepo (fosfomycin) for Injection

January 10, 2020

• Alnylam Initiates Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for Lumasiran for the Treatment of Primary Hyperoxaluria Type 1 (PH1)

January 13, 2020

• Chiasma Announces FDA Acceptance of Mycapssa New Drug Application Resubmission

January 14, 2020

• Nektar Issues Statement Regarding FDA Advisory Committee Vote for Oxycodegol

January 16, 2020

• TG Therapeutics Initiates Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration for Umbralisib as a Treatment for Patients with Previously Treated Marginal Zone Lymphoma or Follicular Lymphoma
• Intellipharmaceutics Provides Update on FDA Advisory Committees Meeting for Aximris XR (Oxycodone Hydrochloride extended release) an Abuse Deterrent Opioid Analgesic for the Treatment of Moderate to Severe Pain

January 21, 2020

• FDA Accepts Evoke Pharma’s NDA Resubmission for Gimoti

January 22, 2020

• Supernus Announces FDA Acceptance for Review of New Drug Application for SPN-812 (viloxazine hydrochloride) for the Treatment of ADHD
• Jazz Pharmaceuticals Submits New Drug Application for JZP-258 for Cataplexy and Excessive Daytime Sleepiness Associated with Narcolepsy

January 27, 2020

• Liquidia Submits New Drug Application for LIQ861 (treprostinil) Inhalation Powder to FDA for the Treatment of Pulmonary Arterial Hypertension (PAH)
• Corium, Inc. Announces FDA Filing Acceptance of New Drug Application for Adlarity (donepezil transdermal system) for the Treatment of Alzheimer’s Disease
• FDA Grants Priority Review of Belantamab Mafodotin for Patients with Relapsed or Refractory Multiple Myeloma

January 28, 2020

• Alkermes Announces U.S. Food and Drug Administration Acceptance of ALKS 3831 New Drug Application for Treatment of Schizophrenia and Bipolar I Disorder

January 29, 2020

• Lilly Receives FDA Priority Review for the Selpercatinib New Drug Application

February 7, 2020

• NDA Accepted for Filing by the FDA for Antisense Oligonucleotide Viltolarsen (NS-065/NCNP-01)

February 10, 2020

• Trevena Resubmits New Drug Application for Oliceridine
• Aquestive Therapeutics Announces U.S. Food and Drug Administration Filing Acceptance of New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film

February 11, 2020

• FibroGen Announces U.S. FDA Acceptance of New Drug Application for Roxadustat for the Treatment of Anemia of Chronic Kidney Disease

February 12, 2020

• Deciphera Pharmaceuticals Announces U.S. Food And Drug Administration Acceptance Of New Drug Application And Priority Review For Ripretinib In Patients With Advanced Gastrointestinal Stromal Tumors

February 13, 2020

• Seattle Genetics Announces FDA Filing Acceptance for Priority Review of Tucatinib New Drug Application (NDA) for Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer
• U.S. Food and Drug Administration (FDA) Accepts for Priority Review Bristol-Myers Squibb’s Biologics License Application (BLA) for Lisocabtagene Maraleucel (liso-cel) for Adult Patients with Relapsed or Refractory Large B-Cell Lymphoma

February 17, 2020

• PharmaMar and Jazz Pharmaceuticals Announce FDA Acceptance and Priority Review of New Drug Application for Lurbinectedin in Relapsed Small Cell Lung Cancer

February 18, 2020

• FDA Accepts BioCryst’s NDA for Oral, Once Daily Berotralstat (BCX7353) to Prevent HAE Attacks

February 19, 2020

• Eton Pharmaceuticals Provides Update on ET-105 Program
• Heron Therapeutics Announces FDA Extension of Review Period for NDA for HTX-011 for the Management of Postoperative Pain

February 24, 2020

• FDA Accepts Genentech’s Biologics License Application for Fixed-Dose Subcutaneous Combination of Perjeta And Herceptin For HER2-Positive Breast Cancer

February 27, 2020

• Zogenix Announces FDA Extension of Review Period for Fintepla in Dravet Syndrome

March 2, 2020

• U.S. FDA Accepts Regulatory Submission for Tanezumab, a Potential First-in-Class Treatment for Patients with Chronic Pain Due to Moderate-to-Severe Osteoarthritis
• Mallinckrodt Initiates Rolling Submission of New Drug Application to the U.S. Food and Drug Administration (FDA) for Terlipressin for the Treatment of Patients with Hepatorenal Syndrome Type 1 (HRS-1)
• KemPharm Submits KP415 NDA to the FDA for the Treatment of ADHD
• FDA Accepts MorphoSys' Biologics License Application (BLA) and Grants Priority Review for Tafasitamab and Lenalidomide for the Treatment of Relapsed/Refractory DLBCL

March 4, 2020

• Zosano Pharma Announces FDA Acceptance of 505(b)(2) New Drug Application for Qtrypta™ for the Acute Treatment of Migraine

March 5, 2020

• Urovant Sciences Announces U.S. FDA Acceptance of New Drug Application for Vibegron for the Treatment of Overactive Bladder
• TG Therapeutics Receives Orphan Drug Designation for Umbralisib from the U.S. Food and Drug Administration for the Treatment of Follicular Lymphoma

March 9, 2020

• Athenex Announces FDA Acceptance for Filing of U.S. NDA for Tirbanibulin Ointment in Actinic Keratosis
• Almirall Announces FDA Acceptance for Filing of U.S. New Drug Application (NDA) for Tirbanibulin in Actinic Keratosis

March 13, 2020

• Fennec Pharmaceuticals Announces FDA Filing Acceptance and Priority Review of New Drug Application for Pedmark

March 17, 2020

• Mallinckrodt Completes Rolling Submission of New Drug Application to the U.S. Food and Drug Administration (FDA) for Terlipressin for the Treatment of Patients with Hepatorenal Syndrome Type 1 (HRS-1)

March 18, 2020

• Janssen Submits Ponesimod New Drug Application to the U.S. FDA for Treatment of Adults with Relapsing Multiple Sclerosis

March 23, 2020

• Eiger BioPharmaceuticals Completes Submission of New Drug Application to FDA for Lonafarnib for Treatment of Progeria and Progeroid Laminopathies

March 31, 2020

• AVEO Oncology Announces Submission of New Drug Application to U.S. FDA for Tivozanib in Patients with Relapsed or Refractory Renal Cell Carcinoma
• Bristol Myers Squibb and bluebird bio Announce Submission of Biologics License Application (BLA) for Anti-BCMA CAR T Cell Therapy Idecabtagene Vicleucel (Ide-cel, bb2121) to FDA

April 1, 2020

• Y-mAbs Announces Submission of Naxitamab Biologics License Application to U.S. FDA

April 7, 2020

• Alnylam Completes Rolling Submission of New Drug Application to the U.S. Food and Drug Administration and Submits Marketing Authorization Application to the European Medicines Agency for Lumasiran for the Treatment of Primary Hyperoxaluria Type 1

April 8, 2020

• Liquidia Announces FDA Acceptance of New Drug Application for LIQ861 (treprostinil) Inhalation Powder for the Treatment of Pulmonary Arterial Hypertension

April 22, 2020

• Mallinckrodt Announces U.S. Food and Drug Administration (FDA) Filing Acceptance of New Drug Application for Terlipressin for Treatment of Hepatorenal Syndrome Type 1 (HRS-1)

April 27, 2020

• CytoDyn Submits Completed Biologics License Application (BLA) to the FDA for Leronlimab as a Combination Therapy for Highly Treatment Experienced HIV Patients

April 28, 2020

• Chimerix Receives FDA Clearance for Rolling Submission of New Drug Application for Brincidofovir as a Medical Countermeasure for Smallpox

May 1, 2020

• U.S. Food and Drug Administration (FDA) Accepts for Priority Review Bristol Myers Squibb’s Application for CC-486 for Maintenance Treatment of Adult Patients in Remission with Acute Myeloid Leukemia

May 4, 2020

• Kala Pharmaceuticals Resubmits New Drug Application for Eysuvis for Dry Eye Disease

May 6, 2020

• Bristol Myers Squibb Provides Update on Biologics License Application (BLA) for Lisocabtagene Maraleucel (liso-cel)

May 13, 2020

• Rhythm Pharmaceuticals Announces FDA Acceptance of New Drug Application for Setmelanotide for the Treatment of POMC and LEPR Deficiency Obesities

May 14, 2020

• FDA Grants Priority Review of Sutimlimab, Potential First Approved Treatment of Hemolysis in Adult Patients with Cold Agglutinin Disease

May 19, 2020

• Eiger BioPharmaceuticals Announces FDA Acceptance of NDA for Filing with Priority Review of Zokinvy (lonafarnib) for Treatment of Progeria and Progeroid Laminopathies

May 20, 2020

• Adamis Pharmaceuticals Resubmits Zimhi New Drug Application to FDA

May 22, 2020

• Zealand Pharma Announces FDA acceptance of New Drug Application for the Dasiglucagon HypoPal® Rescue Pen for Treatment of Severe Hypoglycemia

May 26, 2020

• Kala Pharmaceuticals Announces FDA Acceptance of New Drug Application for Eysuvis for Dry Eye Disease

May 29, 2020

• Orphazyme Initiates Rolling Submission of New Drug Application for Arimoclomol with US FDA in Niemann-Pick Disease Type C

June 1, 2020

• Sumitovant Biopharma Announces Myovant Sciences’ Submission of New Drug Application (NDA) to the FDA for Once-Daily Relugolix Combination Tablet for the Treatment of Women with Uterine Fibroids
• Braeburn Submits Request for Final Approval of Brixadi (buprenorphine) Extended-Release Injection for the Treatment of Opioid Use Disorder

June 19, 2020

• Nabriva Therapeutics Receives Complete Response Letter from FDA on NDA for Contepo (fosfomycin) for injection

June 24, 2020

• Mayne Pharma Announces FDA Filing Acceptance of New Drug Application for E4/DRSP in the US

June 26, 2020

• Sarepta Therapeutics Completes Submission of New Drug Application Seeking Approval of Casimersen (SRP-4045) for Patients with Duchenne Muscular Dystrophy Amenable to Skipping Exon 45

June 29, 2020

• Heron Therapeutics Receives Complete Response Letter for HTX-011 for the Management of Postoperative Pain
• Verrica Pharmaceuticals Provides Regulatory Update on VP-102

June 30, 2020

• Mezzion Announces Submission of New Drug Application for its Orphan Drug Udenafil to Treat Patients who have undergone the Fontan Operation for Single Ventricle Heart Disease
• Ardelyx Announces Submission of New Drug Application to the U.S. FDA for Tenapanor for the Control of Serum Phosphorus in Adult Patients with CKD on Dialysis

July 1, 2020

• scPharmaceuticals Announces Furoscix NDA Resubmission
• Blueprint Medicines Announces Submission of New Drug Application to FDA for Pralsetinib for the Treatment of Advanced RET Mutant and RET Fusion-Positive Thyroid Cancers

July 8, 2020

• CorMedix Inc. Reports Submission of Defencath™ New Drug Application
• Biogen Completes Submission of Biologics License Application to FDA for Aducanumab as a Treatment for Alzheimer’s Disease

July 9, 2020

• ChemoCentryx Submits New Drug Application to the U.S. FDA for Avacopan in ANCA-Associated Vasculitis

July 14, 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 15, 2020

• Mallinckrodt Announces U.S. Food and Drug Administration (FDA) Advisory Committee Voted to Recommend Terlipressin for Approval to Treat Patients with Hepatorenal Syndrome Type 1 (HRS-1)

July 16, 2020

• FDA Grants Priority Review to Merck’s New Drug Application for Vericiguat

July 20, 2020

• Orphazyme Completes Rolling Submission of New Drug Application To U.S. FDA for Arimoclomol for Niemann-Pick Disease Type C

July 21, 2020

• Aurinia Announces U.S. Food and Drug Administration Acceptance of the Filing of New Drug Application and Priority Review for Voclosporin for the Treatment of Lupus Nephritis

July 27, 2020

• scPharmaceuticals Announces FDA Acceptance of Furoscix New Drug Application Resubmission
• Foresee Pharmaceuticals Announces Submission of NDA for FDA Approval of LMIS 50 mg

July 29, 2020

• Bristol Myers Squibb and bluebird bio Announce Submission of Biologics License Application (BLA) to FDA for Idecabtagene Vicleucel (Ide-cel, bb2121) for Adults with Relapsed and Refractory Multiple Myeloma

August 10, 2020

• Gilead Submits New Drug Application to U.S. Food and Drug Administration for Veklury (remdesivir) for the Treatment of COVID-19

August 11, 2020

• Fennec Pharmaceuticals Receives 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

August 12, 2020

• FDA Accepts Evinacumab Biologics License Application for Priority Review as a Treatment for Patients with HoFH, an Ultra-rare Inherited Form of High Cholesterol

August 13, 2020

• TG Therapeutics Announces FDA Acceptance of New Drug Application for Umbralisib as a Treatment for Patients with Previously Treated Marginal Zone Lymphoma and Follicular Lymphoma

August 17, 2020

• G1 Therapeutics Announces Acceptance and Priority Review of NDA for Trilaciclib for Patients with Small Cell Lung Cancer

August 18, 2020

• Gilead Receives Complete Response Letter for Filgotinib for the Treatment of Moderately to Severely Active Rheumatoid Arthritis

August 19, 2020

• BioMarin Receives Complete Response Letter (CRL) from FDA for Valoctocogene Roxaparvovec Gene Therapy for Severe Hemophilia A

August 20, 2020

• BioMarin Submits New Drug Application to U.S. Food and Drug Administration for Vosoritide to Treat Children with Achondroplasia

August 24, 2020

• Tricida Receives Complete Response Letter from the FDA for its New Drug Application for Veverimer for the Treatment of Metabolic Acidosis and Slowing of Kidney Disease Progression in Patients with Metabolic Acidosis Associated with CKD

August 25, 2020

• Sarepta Therapeutics Announces FDA Acceptance of Casimersen (SRP-4045) New Drug Application for Patients with Duchenne Muscular Dystrophy Amenable to Skipping Exon 45
• FDA Accepts Filing of New Drug Application for Tepotinib for the Treatment of Patients with Metastatic NSCLC with METex14 Skipping Alterations

August 31, 2020

• CorMedix Inc. Announces FDA Acceptance for Filing and Priority Review of New Drug Application for Defencath

September 1, 2020

• Mirum Pharmaceuticals Initiates Rolling Submission of a New Drug Application for Maralixibat for the Treatment of Cholestatic Pruritus in Patients with Alagille Syndrome and Launches Expanded Access Program

September 8, 2020

• Liminal BioSciences Announces Resubmission of Biologics License Application to U.S. Food and Drug Administration for Ryplazim (plasminogen)

September 10, 2020

• Sol-Gel Technologies Announces FDA Acceptance for Filing of New Drug Application for Epsolay (benzoyl peroxide) for the Treatment of Inflammatory Lesions of Rosacea

September 14, 2020

• Mallinckrodt Receives a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for Terlipressin for the Treatment of Hepatorenal Syndrome Type 1 (HRS-1)

September 15, 2020

• Apellis Announces Submission of Pegcetacoplan Marketing Applications to FDA and EMA for Patients with PNH
• Ardelyx Announces FDA Acceptance for Filing of its New Drug Application of Tenapanor for the Control of Serum Phosphorus in Adult Patients with CKD on Dialysis

September 16, 2020

• Orphazyme Announces FDA Acceptance and Priority Review of New Drug Application for Arimoclomol for Niemann-Pick Disease Type C

September 21, 2020

• Liminal BioSciences Provides Update on Progress on BLA for Ryplazim (plasminogen)

September 22, 2020

• U.S. Food and Drug Administration (FDA) Accepts for Priority Review Bristol Myers Squibb and bluebird bio Application for Anti-BCMA CAR T Cell Therapy Idecabtagene Vicleucel (Ide-cel, bb2121)

September 24, 2020

• ADC Therapeutics Submits Biologics License Application to the U.S. Food and Drug Administration for Loncastuximab Tesirine for Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma

September 25, 2020

• Aquestive Therapeutics Receives Complete Response Letter from FDA for Libervant (diazepam) Buccal Film for Management of Seizure Clusters

September 29, 2020

• BridgeBio Pharma And Affiliate Origin Biosciences Announces FDA Acceptance Of Its New Drug Application For Fosdenopterin For The Treatment Of MoCD Type A

September 30, 2020

• Kadmon Announces Submission of New Drug Application to the U.S. FDA for Belumosudil in Patients with Chronic Graft-Versus-Host Disease

October 9, 2020

• Foresee Pharmaceuticals Announces NDA for Camcevi™ 42mg Accepted for Review by the FDA
• FDA Advisory Committee Votes in Support of ALKS 3831 for the Treatment of Schizophrenia and Bipolar I Disorder

October 13, 2020

• CTI BioPharma Initiates Rolling Submission of New Drug Application (NDA) for Pacritinib in Myelofibrosis Patients with Severe Thrombocytopenia

October 14, 2020

• Scynexis Announces Submission of New Drug Application to the U.S. Food and Drug Administration for Oral Ibrexafungerp for the Treatment of Vaginal Yeast Infection

October 21, 2020

• Zosano Pharma Receives Complete Response Letter from FDA for Qtrypta

November 2, 2020

• Provention Bio Completes Rolling Submission of the Biologics License Application (BLA) for Teplizumab for the Delay or Prevention of Clinical Type 1 Diabetes in At-risk Individuals
• FDA Accepts BioMarin's New Drug Application for Vosoritide to Treat Children with Achondroplasia

November 8, 2020

• Liminal BioSciences Announces FDA Extension of Review Period for Ryplazim (plasminogen) BLA

November 9, 2020

• Impel Neuropharma Announces FDA Submission of New Drug Application for INP104 for the Acute Treatment of Migraine
• Bayer Submits Regulatory Applications for Investigational Drug Finerenone in the U.S. and the EU for Patients with Chronic Kidney Disease and Type 2 Diabetes
• Supernus Provides Regulatory Update for SPN-812

November 13, 2020

• Heron Therapeutics Resubmits New Drug Application to FDA for HTX-011 for the Treatment of Postoperative Pain
• FDA Issues Complete Response Letter for Sutimlimab, an Investigational Treatment for Hemolysis in Adults with Cold Agglutinin Disease

November 16, 2020

• Adamis Pharmaceuticals Receives a Complete Response Letter from the FDA Regarding Zimhi
• Apellis Announces FDA Acceptance and Priority Review of the New Drug Application for Pegcetacoplan for the Treatment of PNH

November 17, 2020

• Alkermes Receives FDA Complete Response Letter Related to ALKS 3831 Manufacturing Records Review

November 18, 2020

• CorMedix Inc. Announces FDA Decision That Advisory Committee Meeting for New Drug Application for Defencath is Not Needed
• Omeros Submits its Biologics License Application to U.S. FDA for Narsoplimab in HSCT-TMA
• Samsung Bioepis and Biogen Announce FDA Filing Acceptance of SB11, A Proposed Biosimilar Referencing Lucentis® (ranibizumab)

November 25, 2020

• Liquidia Receives Complete Response Letter from FDA for LIQ861 (treprostinil) Inhalation Powder for the Treatment of Pulmonary Arterial Hypertension

November 30, 2020

• Iterum Therapeutics Submits New Drug Application to U.S. Food and Drug Administration for Oral Sulopenem
• Kadmon Announces FDA Acceptance of NDA for Belumosudil in Patients With Chronic Graft-Versus-Host Disease

December 1, 2020

• BridgeBio Pharma And Affiliate QED Therapeutics Announce FDA Acceptance Of New Drug Application For Infigratinib For The Treatment Of Cholangiocarcinoma
• TG Therapeutics Initiates Rolling Submission of Biologics License Application to U.S. Food and Drug Administration for Ublituximab in Combination with Umbralisib as a Treatment for Patients with Chronic Lymphocytic Leukemia

December 3, 2020

• Janssen Submits Application to U.S. FDA Seeking Approval of Amivantamab for the Treatment of Patients with Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

December 7, 2020

• Chimerix Announces FDA Acceptance of New Drug Application for Brincidofovir as a Medical Countermeasure for Smallpox
• Scynexis Announces FDA Acceptance and Priority Review of New Drug Application for Oral Ibrexafungerp for the Treatment of Vaginal Yeast Infections
• scPharmaceuticals Inc. Receives Complete Response Letter from FDA for Furoscix
• Sol-Gel Technologies Announces FDA Acceptance for Filing of New Drug Application for Twyneo for the Treatment of Acne Vulgaris

December 8, 2020

• Lipocine Announces Tentative Approval of TLANDO
• Albireo Submits for U.S. FDA and EMA Product Approval of Once-Daily Odevixibat for PFIC

December 10, 2020

• Atox Bio Announces FDA Acceptance to File the NDA for Reltecimod to Treat Suspected Organ Dysfunction or Failure in Patients with Necrotizing Soft Tissue Infection ("Flesh-Eating Disease")

December 15, 2020

• U.S. Food and Drug Administration Accepts New Drug Application for Review, Grants Priority Review for Takeda’s TAK-721 (budesonide oral suspension) for the Treatment of Eosinophilic Esophagitis

December 18, 2020

• Oyster Point Pharma Submits New Drug Application to the U.S. Food and Drug Administration for OC-01 (varenicline) Nasal Spray for the Treatment of Signs and Symptoms of Dry Eye Disease

December 21, 2020

• Sesen Bio Submits Completed Biologics License Application to the FDA for Vicineum and Has Requested Priority Review

December 23, 2020

• Verrica Pharmaceuticals Announces Resubmission of New Drug Application for VP-102 for the Treatment of Molluscum Contagiosum
• Verrica Pharmaceuticals Announces Resubmission of New Drug Application for VP-102 for the Treatment of Molluscum Contagiosum

December 28, 2020

• Chi-Med Initiates Rolling Submission of NDA to U.S. FDA for Surufatinib for the Treatment of Advanced Neuroendocrine Tumors
• Cara Therapeutics Submits New Drug Application to U.S. Food and Drug Administration for Korsuva Injection in Hemodialysis Patients with Moderate-to-Severe Pruritus
• Bio-Thera Solutions Announces FDA Accepts Biologics License Application for BAT1706, a Proposed Biosimilar to Avastin

December 29, 2020

• Eyenovia Submits New Drug Application to FDA for Pharmacologic Mydriasis with MydCombi
• FDA Accepts Alkermes' Resubmission of New Drug Application for ALKS 3831