New Drug Applications

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 Receives FDA Complete Response Letter for KPI-121 0.25% NDA and Plans to Respond with Data From STRIDE 3 Trial - August 8, 2019
• Kala Pharmaceuticals Announces New Drug Application for KPI-121 0.25% for Dry Eye Disease Has Been Accepted for Review by the U.S. Food and Drug Administration - December 26, 2018
• 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

avapritinib

Company: Blueprint Medicines Corporation
Treatment for: Gastrointestinal Stromal Tumor

Avapritinib (formerly known as BLU-285) is a potent and highly selective KIT and PDGFRα inhibitor in development for the treatment of PDGFRα Exon 18 mutant gastrointestinal stromal tumors (GIST) and fourth-line GIST.

• Blueprint Medicines Announces FDA Acceptance of New Drug Application for Avapritinib for the Treatment of PDGFRA Exon 18 Mutant GIST and Fourth-Line GIST - August 7, 2019
• Blueprint Medicines Submits New Drug Application to U.S. Food and Drug Administration for Avapritinib for the Treatment of PDGFRA Exon 18 Mutant GIST and Fourth-Line GIST - June 14, 2019

FMX103 (minocycline) Topical Foam

Company: Foamix Pharmaceuticals Ltd.
Treatment for: Papulopustular Rosacea

FMX103 is a topical minocycline foam formulation in development for the treatment of moderate-to-severe papulopustular rosacea.

• Foamix Submits New Drug Application to U.S. FDA for FMX103 for the Treatment of Moderate-to-Severe Papulopustular Rosacea - August 5, 2019

triheptanoin

Company: Ultragenyx Pharmaceutical Inc.
Treatment for: Long-Chain Fatty Acid Oxidation Disorders

Triheptanoin is a synthetic triglyceride compound in development for the treatment of long-chain fatty acid oxidation disorders.

• Ultragenyx Announces Submission of New Drug Application to FDA for UX007 (triheptanoin) for Treatment of Long-Chain Fatty Acid Oxidation Disorders - August 1, 2019
• Ultragenyx Granted Additional Orphan Drug Designations for Triheptanoin - April 23, 2015
• Ultragenyx Investigational New Drug Application for Triheptanoin for the Treatment of Glucose Transporter Type-1 Deficiency Syndrome is in Effect - December 17, 2013

ET-105 (lamotrigine)

Company: Eton Pharmaceuticals, Inc.

ET-105 is an oral liquid formulation of lamotrigine in development as an adjunct therapy for partial seizures, primary generalized tonic-clonic seizures, and generalized seizures of Lennox-Gastaut syndrome in patients two years of age and older.

• Eton Pharmaceuticals Announces FDA Acceptance of New Drug Application for ET-105 - August 1, 2019

dasotraline

Company: Sunovion Pharmaceuticals Inc.
Treatment for: Attention Deficit Hyperactivity Disorder (ADHD); Binge Eating Disorder

Dasotraline is a dual dopamine and norepinephrine reuptake inhibitor (DNRI) in development for the treatment of attention deficit hyperactivity disorder (ADHD) and binge eating disorder.

• Sunovion Announces Acceptance by the U.S. FDA of the New Drug Application for Dasotraline for the Treatment of Adults with Moderate-to-Severe Binge Eating Disorder - July 30, 2019
• FDA Issues a Complete Response Letter for New Drug Application for Dasotraline for the Treatment of ADHD - August 31, 2018
• Sunovion Announces FDA Acceptance for Review of New Drug Application for Dasotraline for the Treatment of ADHD - November 10, 2017
• Sunovion Submits New Drug Application for Dasotraline to the FDA for the Treatment of Patients with ADHD - August 31, 2017

tazemetostat

Company: Epizyme, Inc.
Treatment for: Epithelioid Sarcoma

Tazemetostat is an oral, first-in-class, EZH2 inhibitor in development for the treatment of patients with metastatic or locally advanced epithelioid sarcoma.

• Epizyme Announces FDA Filing Acceptance of New Drug Application and Priority Review for Tazemetostat for the Treatment of Epithelioid Sarcoma - July 25, 2019
• Epizyme Submits New Drug Application to the U.S. FDA for Tazemetostat for the Treatment of Patients with Epithelioid Sarcoma - May 30, 2019

Brinavess (vernakalant) Intravenous Injection - formerly Kynapid

Company: Cardiome Pharma Corp.
Treatment for: Atrial Fibrillation

Brinavess (vernakalant) is an investigational antiarrhythmic drug in development for the rapid conversion of adult patients with recent onset atrial fibrillation (AF).

• FDA Accepts Correvio's Resubmitted New Drug Application for Brinavess (vernakalant) - July 25, 2019
• Correvio Resubmits Brinavess (vernakalant) New Drug Application to U.S. FDA for the Treatment of Patients with Recent Onset Atrial Fibrillation - June 24, 2019
• Cardiome Provides U.S. Regulatory Update for Brinavess - August 21, 2017
• Additional Clinical Trial to be Conducted for Kynapid Under FDA Special Protocol Agreement - August 12, 2009
• Cardiome Provides Kynapid Regulatory Update - October 9, 2008
• Cardiome And Astellas Announce Receipt Of FDA Approvable Letter For Kynapid - August 11, 2008
• Cardiome And Astellas Announce Kynapid Regulatory Update - January 22, 2008
• FDA Advisory Committee Recommends Approval of Kynapid for Acute Atrial Fibrillation - December 12, 2007
• Cardiome And Astellas Announce Regulatory Extension - August 30, 2007
• Cardiome And Astellas Announce Acceptance Of NDA For Review - February 19, 2007
• Cardiome and Astellas Pharma US, Inc. Announce Re-Submission of NDA for Vernakalant (IV) - December 18, 2006
• Cardiome Announces Refusal to File Decision By the FDA - May 31, 2006
• New Drug Application Submitted For RSD1235 - March 31, 2006

lumateperone

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

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

• Intra-Cellular Therapies Provides Update on FDA Advisory Committee Meeting for Lumateperone for the Treatment of Schizophrenia - July 23, 2019
• Intra-Cellular Therapies Announces FDA Advisory Committee Meeting to Review the NDA for Lumateperone for the Treatment of Schizophrenia in Adults - June 13, 2019
• Intra-Cellular Therapies Announces FDA Acceptance of New Drug Application for Lumateperone for the Treatment of Schizophrenia - December 11, 2018
• Intra-Cellular Therapies Completes Submission of New Drug Application for Lumateperone for Treatment of Schizophrenia - September 28, 2018
• Intra-Cellular Therapies Initiates Rolling Submission of New Drug Application for Lumateperone for Treatment of Schizophrenia - June 6, 2018

elexacaftor, ivacaftor and tezacaftor

Company: Vertex Pharmaceuticals Incorporated
Treatment for: Cystic Fibrosis

Elexacaftor (VX-445), tezacaftor and ivacaftor is a triple combination regimen in development for the treatment of cystic fibrosis.

• Vertex Submits New Drug Application to the U.S. FDA for Triple Combination Regimen of VX-445 (Elexacaftor), Tezacaftor and Ivacaftor in Cystic Fibrosis - July 22, 2019

crizanlizumab

Company: Novartis
Treatment for: Sickle Cell Anemia

Crizanlizumab (SEG101) is an investigational P-selectin inhibitor in development for the prevention of vaso-occlusive crises (VOCs) in patients with sickle cell disease (SCD).

• FDA Accepts File and Accelerates Review of Novartis Sickle Cell Disease Medicine Crizanlizumab (SEG101) - July 16, 2019

enfortumab vedotin

Company: Astellas and Seattle Genetics
Treatment for: Urothelial Carcinoma

Enfortumab vedotin is a Nectin-4 targeted antibody-drug conjugate (ADC) in development for the treatment of patients with locally advanced or metastatic urothelial cancer.

• Astellas and Seattle Genetics Announce Submission of Biologics License Application to FDA for Enfortumab Vedotin for Patients with Locally Advanced or Metastatic Urothelial Cancer - July 16, 2019

isatuximab

Company: Sanofi
Treatment for: Multiple Myeloma

Isatuximab is an investigational monoclonal antibody targeting a specific epitope on the CD38 receptor in development for the treatment of relapsed/refractory multiple myeloma (RRMM).

• FDA to Review Isatuximab as a Potential Treatment for Relapsed/Refractory Multiple Myeloma - July 10, 2019

opicapone

Company: Neurocrine Biosciences, Inc.

• Neurocrine Biosciences Announces FDA Acceptance of New Drug Application for Opicapone as an Adjunctive Treatment for Patients with Parkinson's Disease - July 10, 2019

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).

• Acacia Pharma Plans to Resubmit the Barhemsys NDA in Q3 2019 - July 8, 2019
• Complete Response Letter from FDA for Barhemsys - May 3, 2019
• New Barhemsys PDUFA Date Confirmed for 5 May 2019 - December 7, 2018
• Acacia Pharma Resubmits Barhemsys New Drug Application - November 6, 2018
• 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

Talicia (amoxicillin, omeprazole and rifabutin) Capsules

Company: RedHill Biopharma Ltd.
Treatment for: Helicobacter pylori Infection

Talicia (RHB-105) is a fixed-dose combination of two antibiotics, rifabutin, and amoxicillin, and a proton pump inhibitor (PPI), omeprazole, in development for the treatment of Helicobacter pylori infection.

• RedHill Biopharma Announces FDA Acceptance of New Drug Application for Talicia - July 3, 2019
• RedHill Biopharma Submits New Drug Application for Talicia for H. pylori Infection - May 7, 2019

Fintepla (fenfluramine)

Company: Zogenix, Inc.
Treatment for: Dravet Syndrome

Fintepla (ZX008, low-dose fenfluramine) is an amphetamine derivative in development for the treatment of seizures associated with Dravet syndrome.

• Zogenix Announces FDA Agreement to Proceed with Resubmission of Fintepla NDA - June 27, 2019
• Zogenix Receives Refusal to File Letter from U.S. Food and Drug Administration for Fintepla New Drug Application - April 8, 2019
• Zogenix Submits New Drug Application to U.S. Food & Drug Administration for Fintepla for the Treatment of Dravet Syndrome - February 6, 2019

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 Receives Complete Response Letter from U.S. FDA for use of Edsivo (celiprolol) in vEDS Patients - June 25, 2019
• Acer Therapeutics Submits NDA for Edsivo (celiprolol) for the Treatment of Vascular Ehlers-Danlos syndrome (vEDS) - October 29, 2018

Ryaltris (mometasone furoate and olopatadine hydrochloride) Nasal Spray

Company: Glenmark Pharmaceuticals, Inc.
Treatment for: Allergic Rhinitis

Ryaltris (mometasone and olopatadine) is an investigational steroid and antihistamine fixed-dose combination nasal spray in development as a treatment for seasonal allergic rhinitis (SAR) in patients 12 years of age and older.

• FDA Issues Complete Response Letter for Ryaltris NDA - June 25, 2019
• Glenmark Pharmaceuticals Announces New Data Presentations on Ryaltris at the ACAAI Annual Scientific Meeting 2018 - November 15, 2018
• Glenmark Pharmaceuticals Announces the Company's First NDA for Ryaltris for Patients with Seasonal Allergic Rhinitis - May 21, 2018