New Drug Applications Archive for 2019

January 2, 2019

• Banner Receives FDA Tentative Approval for Bafiertam for the Treatment of Relapsing Forms of Multiple Sclerosis

January 4, 2019

• Nabriva Therapeutics Announces Acceptance of the New Drug Application for Intravenous Contepo to Treat Complicated Urinary Tract Infections by FDA

January 14, 2019

• US FDA Accepts Regulatory Submissions for Review of Tafamidis to Treat Transthyretin Amyloid Cardiomyopathy

January 15, 2019

• New Drug Application for Insomnia Disorder Treatment Lemborexant Submitted in the United States

January 17, 2019

• FDA Advisory Committee Votes on Zynquista (sotagliflozin) as Treatment for Adults with Type 1 Diabetes

January 21, 2019

• Amgen And UCB Receive Positive Vote From FDA Advisory Committee In Favor Of Approval For Evenity (romosozumab)

January 30, 2019

• Sunovion Receives Complete Response Letter from FDA for Apomorphine Sublingual Film (APL-130277)

February 1, 2019

• Alkermes Receives Complete Response Letter From U.S. Food and Drug Administration for ALKS 5461 New Drug Application

February 4, 2019

• SK Life Science Announces FDA Acceptance of NDA Submission for Cenobamate, an Investigational Antiepileptic Drug

February 5, 2019

• Pain Therapeutics Announces Feedback from Recent Meeting With FDA on Remoxy
• FDA Grants Priority Review for Daiichi Sankyo’s New Drug Application for CSF1R Inhibitor Pexidartinib for Treatment of Patients with TGCT, a Rare, Debilitating Tumor
• FDA Accepts for Review New Drug Application (NDA) for Merck’s Investigational Combination of Imipenem/Cilastatin and Relebactam

February 6, 2019

• Zogenix Submits New Drug Application to U.S. Food & Drug Administration for Fintepla for the Treatment of Dravet Syndrome

February 12, 2019

• FDA Advisory Committee Recommends Approval of Spravato (esketamine) Nasal Spray for Adults with Treatment-Resistant Depression
• Harmony Biosciences Announces File Acceptance Of Its New Drug Application For Pitolisant

February 14, 2019

• Motif Bio Receives Complete Response Letter From The FDA
• Sarepta Announces FDA Acceptance of Golodirsen (SRP-4053) New Drug Application for Patients with Duchenne Muscular Dystrophy Amenable to Skipping Exon 53

February 18, 2019

• FDA Grants Priority Review to Genentech’s Personalized Medicine Entrectinib
• JDP Therapeutics Announces U.S. FDA Filing Acceptance of New Drug Application for Quzyttir for Indication of Acute Urticaria

February 19, 2019

• Nabriva Therapeutics Announces Acceptance of New Drug Applications by the FDA for Intravenous and Oral Lefamulin to Treat Community-Acquired Bacterial Pneumonia in Adults
• AbbVie Announces New Drug Application Accepted for Priority Review by FDA for Upadacitinib for Treatment of Moderate to Severe Rheumatoid Arthritis

February 25, 2019

• Alkermes and Biogen Announce U.S. Food and Drug Administration Acceptance of Diroximel Fumarate New Drug Application for Multiple Sclerosis

February 27, 2019

• Karyopharm Announces Outcome of FDA Advisory Committee Meeting Reviewing Selinexor for the Treatment of Patients with Triple Class Refractory Multiple Myeloma
• Bayer Completes Rolling Submission of NDA for Investigational Drug Darolutamide for the Treatment of Non-Metastatic Castration-Resistant Prostate Cancer (nmCRPC)

March 4, 2019

• Intellipharmaceutics Announces Resubmission of New Drug Application to the U.S. FDA for its Oxycodone ER

March 5, 2019

• U.S. FDA Grants Priority Review for Fedratinib New Drug Application in Myelofibrosis

March 7, 2019

• Foamix Announces FDA Acceptance of New Drug Application for FMX101 Minocycline Foam for the Treatment of Moderate-to-Severe Acne

March 8, 2019

• TB Medicine Pretomanid Enters Regulatory Review Process in the United States

March 11, 2019

• Allergan Announces FDA Acceptance of New Drug Application for Ubrogepant for the Acute Treatment of Migraine

March 12, 2019

• Eisai and Imbrium Therapeutics Announce U.S. FDA Filing Acceptance of New Drug Application for Lemborexant for the Treatment of Insomnia

March 14, 2019

• Karyopharm Announces FDA Extension of Review Period for Selinexor New Drug Application
• Evoke Pharma Submits Response to FDA Review Letter for Gimoti NDA

March 25, 2019

• FDA Issues Complete Response Letter for Zynquista (sotagliflozin)
• Celgene Submits Application to FDA for Ozanimod for the Treatment of Relapsing Forms of Multiple Sclerosis

March 29, 2019

• Foresee Pharmaceuticals Announces Submission of NDA for FDA Approval of LMIS 50 mg

April 2, 2019

• Evoke Pharma Receives Complete Response Letter and Recommendations to Address Deficiencies from FDA for Gimoti NDA

April 3, 2019

• Sandoz Resubmits Biosimilar Pegfilgrastim Application to US FDA

April 4, 2019

• Kyowa Kirin Announces FDA Acceptance of Istradefylline (KW-6002) New Drug Application Resubmission in the US

April 5, 2019

• Celgene Corporation and Acceleron Pharma Announce Submission of Luspatercept Biologics License Application to U.S. FDA

April 8, 2019

• Zogenix Receives Refusal to File Letter from U.S. Food and Drug Administration for Fintepla New Drug Application

April 9, 2019

• Cosmo Pharmaceuticals Announces Submission of Remimazolam NDA to FDA

April 15, 2019

• Novartis Announces FDA Filing Acceptance and Priority Review of Brolucizumab (RTH258) for Patients with Wet AMD

April 29, 2019

• Janssen Announces Submission of New Drug Application to U.S. FDA For the First Monthly, Injectable, Two-Drug Regimen of Rilpivirine and Cabotegravir for Treatment of HIV
• U.S. FDA Accepts New Drug Application and Grants Priority Review for Darolutamide

April 30, 2019

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

May 1, 2019

• Heron Therapeutics Receives Complete Response Letter For HTX-011 For The Management Of Postoperative Pain

May 3, 2019

• Complete Response Letter from FDA for Barhemsys

May 5, 2019

• Esperion Announces U.S. FDA Acceptance of New Drug Applications (NDAs) for Both Bempedoic Acid and the Bempedoic Acid / Ezetimibe Combination Tablet for Filing and Regulatory Review

May 6, 2019

• Zynerba Pharmaceuticals Receives Fast Track Designation for Zygel for the Treatment of Behavioral Symptoms Associated with Fragile X Syndrome (FXS)

May 7, 2019

• RedHill Biopharma Submits New Drug Application for Talicia for H. pylori Infection

May 14, 2019

• Lipocine Announces Tlando NDA PDUFA Action Date of November 9, 2019

May 17, 2019

• Agile Therapeutics Resubmits New Drug Application (NDA) for its Transdermal Low-Dose Contraceptive Patch, Twirla

May 22, 2019

• Avadel Pharmaceuticals Announces FDA Acceptance of New Drug Application for AV001

May 30, 2019

• Epizyme Submits New Drug Application to the U.S. FDA for Tazemetostat for the Treatment of Patients with Epithelioid Sarcoma

June 3, 2019

• US FDA Review for Scenesse Extended 3 Months

June 4, 2019

• Celgene Corporation and Acceleron Pharma Announce U.S. FDA Accepts Luspatercept Biologics License Application in Myelodysplastic Syndromes and Beta-Thalassemia

June 5, 2019

• Alnylam Completes Rolling Submission of New Drug Application to U.S. Food and Drug Administration (FDA) for Givosiran for the Treatment of Acute Hepatic Porphyria

June 6, 2019

• US FDA and EMA Accept Applications for Ozanimod for the Treatment of Relapsing Forms of Multiple Sclerosis
• Xeris Pharmaceuticals Receives Notification of PDUFA Date Extension for Gvoke

June 13, 2019

• Intra-Cellular Therapies Announces FDA Advisory Committee Meeting to Review the NDA for Lumateperone for the Treatment of Schizophrenia in Adults

June 14, 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 21, 2019

• Daiichi Sankyo Provides Update on FDA Review of Quizartinib for the Treatment of Patients with Relapsed/Refractory FLT3-ITD AML

June 24, 2019

• Correvio Resubmits Brinavess (vernakalant) New Drug Application to U.S. FDA for the Treatment of Patients with Recent Onset Atrial Fibrillation

June 25, 2019

• FDA Issues Complete Response Letter for Ryaltris NDA
• Acer Therapeutics Receives Complete Response Letter from U.S. FDA for use of Edsivo (celiprolol) in vEDS Patients

June 27, 2019

• Zogenix Announces FDA Agreement to Proceed with Resubmission of Fintepla NDA

July 3, 2019

• RedHill Biopharma Announces FDA Acceptance of New Drug Application for Talicia

July 8, 2019

• Acacia Pharma Plans to Resubmit the Barhemsys NDA in Q3 2019

July 10, 2019

• Neurocrine Biosciences Announces FDA Acceptance of New Drug Application for Opicapone as an Adjunctive Treatment for Patients with Parkinson's Disease
• Horizon Therapeutics plc Submits Teprotumumab Biologics License Application (BLA) for the Treatment of Active Thyroid Eye Disease (TED)
• FDA to Review Isatuximab as a Potential Treatment for Relapsed/Refractory Multiple Myeloma

July 16, 2019

• Astellas and Seattle Genetics Announce Submission of Biologics License Application to FDA for Enfortumab Vedotin for Patients with Locally Advanced or Metastatic Urothelial Cancer
• FDA Accepts File and Accelerates Review of Novartis Sickle Cell Disease Medicine Crizanlizumab (SEG101)

July 22, 2019

• 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 23, 2019

• Intra-Cellular Therapies Provides Update on FDA Advisory Committee Meeting for Lumateperone for the Treatment of Schizophrenia

July 25, 2019

• FDA Accepts Correvio's Resubmitted New Drug Application for Brinavess (vernakalant)
• Epizyme Announces FDA Filing Acceptance of New Drug Application and Priority Review for Tazemetostat for the Treatment of Epithelioid Sarcoma

July 30, 2019

• 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

August 1, 2019

• Eton Pharmaceuticals Announces FDA Acceptance of New Drug Application for ET-105
• Ultragenyx Announces Submission of New Drug Application to FDA for UX007 (triheptanoin) for Treatment of Long-Chain Fatty Acid Oxidation Disorders

August 5, 2019

• Foamix Submits New Drug Application to U.S. FDA for FMX103 for the Treatment of Moderate-to-Severe Papulopustular Rosacea
• Alnylam Announces U.S. Food and Drug Administration (FDA) Granted Priority Review of the Givosiran New Drug Application (NDA) for the Treatment of Acute Hepatic Porphyria

August 7, 2019

• 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 8, 2019

• Kala Pharmaceuticals Receives FDA Complete Response Letter for KPI-121 0.25% NDA and Plans to Respond with Data From STRIDE 3 Trial
• Avadel Pharmaceuticals Receives New PDUFA Date for AV001 of December 15, 2019

August 19, 2019

• Sarepta Therapeutics Receives Complete Response Letter from the US Food and Drug Administration for Golodirsen New Drug Application

August 20, 2019

• FDA Accepts New Drug Application for VX-445 (Elexacaftor), Tezacaftor and Ivacaftor Combination Treatment
• Cassiopea Announces FDA Submission of New Drug Application for Clascoterone Cream 1%

August 21, 2019

• BeiGene Announces U.S. FDA Acceptance and Grant of Priority Review for its New Drug Application of Zanubrutinib in Patients with Relapsed/Refractory Mantle Cell Lymphoma

August 22, 2019

• Clearside Biomedical Provides New Drug Application Update for Xipere (triamcinolone acetonide suprachoroidal injectable suspension)

September 4, 2019

• Tricida Announces Submission of New Drug Application for Veverimer for the Treatment of Metabolic Acidosis in Patients with Chronic Kidney Disease

September 5, 2019

• GBT Announces U.S. Food and Drug Administration Acceptance of New Drug Application and Priority Review for Voxelotor for the Treatment of Sickle Cell Disease

September 6, 2019

• Endo Announces Submission of Biologics License Application to FDA for Collagenase Clostridium Histolyticum (CCH) in Patients with Cellulite

September 9, 2019

• Horizon Therapeutics plc Announces the FDA has Granted Priority Review of the Teprotumumab Biologics License Application (BLA) for the Treatment of Active Thyroid Eye Disease (TED)

September 10, 2019

• Intra-Cellular Therapies Provides Lumateperone Regulatory Update

September 11, 2019

• United Therapeutics Announces FDA Acceptance of Trevyent New Drug Application For Review

September 13, 2019

• FDA Allergenic Products Advisory Committee Votes to Support the Use of Aimmune’s Palforzia (AR101) for Peanut Allergy

September 16, 2019

• Verrica Pharmaceuticals Submits New Drug Application to U.S. Food and Drug Administration for VP-102 for the Treatment of Molluscum Contagiosum

September 17, 2019

• Vertical Pharmaceuticals, LLC, an Osmotica Company, Announces Submission of New Drug Application for RVL-1201

September 24, 2019

• MC2 Therapeutics Announces Submission of NDA for Wynzora Cream (Calcipotriene 0.005% and Betamethasone Dipropionate 0.064%) for Treatment of Plaque Psoriasis

September 26, 2019

• IntelGenx Announces Resubmission of Rizaport New Drug Application
• Zogenix Resubmits New Drug Application for Fintepla for the Treatment of Dravet Syndrome to U.S. Food and Drug Administration
• Acacia Pharma Announces New Barhemsys PDUFA Target Date

October 1, 2019

• Heron Therapeutics Resubmits New Drug Application to FDA for HTX-011 for the Management of Postoperative Pain

October 14, 2019

• Ultragenyx Announces FDA Accepts New Drug Application for UX007 (triheptanoin) for Treatment of Long-chain Fatty Acid Oxidation Disorders

October 17, 2019

• Foamix Announces FDA Acceptance of its New Drug Application for FMX103 Minocycline Foam for the Treatment of Moderate-to-Severe Papulopustular Rosacea

October 21, 2019

• Assertio Therapeutics Provides Regulatory Update on Long-Acting Cosyntropin

October 28, 2019

• Blueprint Medicines Announces FDA Intent to Split Avapritinib New Drug Application into Separate Submissions for PDGFRA Exon 18 Mutant GIST and Fourth-Line GIST
• Heron Therapeutics Announces FDA Acceptance of New Drug Application Resubmission for HTX-011 for Management of Postoperative Pain

October 29, 2019

• FDA Accepts Genentech’s Biologics License Application for Satralizumab for Neuromyelitis Optica Spectrum Disorder

October 30, 2019

• Agile Therapeutics Announces Favorable Outcome of FDA Advisory Committee Meeting for its Investigational Transdermal Contraceptive Patch, Twirla (AG200-15)

October 31, 2019

• FDA Grants Appeal to Recro Pharma for IV Meloxicam New Drug Application

November 4, 2019

• AVEO Oncology Announces Regulatory Update For Tivozanib In Renal Cell Carcinoma

November 7, 2019

• FDA Grants Braeburn’s Citizen Petition Allowing Brixadi (buprenorphine) Extended-Release Injection for Opioid Use Disorder to be Available in December 2020

November 8, 2019

• Cassiopea Announces FDA Acceptance of its New Drug Application for Clascoterone Cream 1%

November 11, 2019

• Supernus Submits New Drug Application for SPN-812 for the Treatment of ADHD
• Lipocine Receives Complete Response Letter for TLANDO™ from U.S. FDA

November 14, 2019

• Tricida Announces FDA Acceptance of New Drug Application for Veverimer
• Agile Therapeutics Announces FDA Extension of Twirla NDA Review Period
• US FDA Accepts Regulatory Submission of New Drug Application for Selumetinib in Neurofibromatosis Type 1 (NF1) and Grants Priority Review

November 19, 2019

• Alkermes Submits New Drug Application to U.S. Food and Drug Administration for ALKS 3831 for Treatment of Schizophrenia and Bipolar I Disorder
• Endo Announces FDA's Acceptance of Original Biologics License Application (BLA) for Collagenase Clostridium Histolyticum (CCH) in Patients with Cellulite

November 20, 2019

• Vertical Pharmaceuticals, LLC, an Osmotica Company, Announces Acceptance of New Drug Application by FDA for RVL-1201 (Oxymetazoline Hydrochloride Ophthalmic Solution, 0.1%) for Acquired Blepharoptosis (Droopy Eyelid)
• MC2 Therapeutics Announces FDA Acceptance of its New Drug Application for Wynzora™ Cream for Treatment of Plaque Psoriasis

November 22, 2019

• Sunovion Resubmits New Drug Application for Apomorphine Sublingual Film

November 25, 2019

• Zogenix Announces FDA Acceptance for Filing of New Drug Application and Priority Review for Fintepla for the Treatment of Dravet Syndrome

November 26, 2019

• Evofem Biosciences Resubmits New Drug Application to U.S. FDA for Amphora® for the Prevention of Pregnancy

November 27, 2019

• Verrica Pharmaceuticals Announces FDA Filing Acceptance of New Drug Application for VP-102 for the Treatment of Molluscum Contagiosum
• Incyte Announces Acceptance and Priority Review of NDA for Pemigatinib as a Treatment for Patients with Cholangiocarcinoma

December 1, 2019

• Innovent Biologics Announces FDA Acceptance of NDA for Pemigatinib in Patients with Previously Treated, Locally Advanced or Metastatic Cholangiocarcinoma with FGFR2 Fusions or Rearrangements

December 2, 2019

• Aquestive Therapeutics Completes Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for Libervant (diazepam) Buccal Film for Management of Seizure Clusters
• Alkindi New Drug Application Submitted to US FDA

December 3, 2019

• BridgeBio Pharma’s Origin Biosciences Initiates Rolling Submission Of New Drug Application With The U.S. FDA For BBP-870 For The Treatment Of MoCD Type A

December 5, 2019

• ViiV Healthcare submits New Drug Application to the FDA for Fostemsavir, an Investigational, First-in-Class Attachment Inhibitor for the Treatment of HIV in Adults with Few Treatment Options Available

December 10, 2019

• Correvio Announces Outcome Of FDA Advisory Committee Meeting Reviewing Brinavess For The Treatment Of Recent Onset Atrial Fibrillation

December 11, 2019

• Kite Submits Biologics License Application to U.S. Food and Drug Administration for Company’s Second CAR T Cell Therapy KTE-X19
• BioCryst Submits New Drug Application for Oral, Once Daily Berotralstat (BCX7353) to Prevent HAE Attacks

December 16, 2019

• Eiger Initiates Rolling Submission of New Drug Application (NDA) with FDA for Lonafarnib for Treatment of Progeria and Progeroid Laminopathies
• Deciphera Pharmaceuticals Announces Submission of New Drug Application to U.S. FDA for Ripretinib in Patients with Advanced Gastrointestinal Stromal Tumors

December 17, 2019

• PharmaMar Has Filed New Drug Application for Lurbinectedin with the FDA for the Treatment of Relapsed Small Cell Lung Cancer

December 18, 2019

• Bristol-Myers Squibb Announces Submission of Biologics License Application for CAR T-Cell Therapy Lisocabtagene Maraleucel (liso-cel) to FDA
• Epizyme Submits New Drug Application to the U.S. FDA for Tazemetostat for the Treatment of Patients with Follicular Lymphoma
• U.S. FDA Acknowledges Receipt of Evofem Biosciences' New Drug Application Resubmission for Amphora for the Prevention of Pregnancy

December 19, 2019

• UroGen Pharma Announces FDA Filing Acceptance and Priority Review of U.S. New Drug Application (NDA) for UGN-101
• MacroGenics Announces Submission of Margetuximab Biologics License Application to U.S. FDA
• Gilead Submits Filgotinib New Drug Application to U.S. Food and Drug Administration Under Priority Review for Rheumatoid Arthritis Treatment

December 20, 2019

• Evoke Resubmits Gimoti New Drug Application to FDA
• Sunovion Announces FDA Filing Acceptance of Resubmitted New Drug Application for Apomorphine Sublingual Film
• Nabriva Therapeutics Resubmits New Drug Application for Intravenous Contepo (fosfomycin) for Injection

December 23, 2019

• Seattle Genetics Announces Submission of Tucatinib New Drug Application to the U.S. FDA for Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer
• BioMarin Submits Biologics License Application to U.S. Food and Drug Administration for Valoctocogene Roxaparvovec to Treat Hemophilia A
• FibroGen Submits New Drug Application to the U.S. FDA for Roxadustat in Patients With Anemia of Chronic Kidney Disease
• Zosano Announces FDA Submission of New Drug Application for Qtrypta

December 24, 2019

• Correvio Receives Complete Response Letter From U.S. FDA for Brinavess and Provides Update on Recent Events

December 26, 2019

• Immunomedics Announces FDA Acceptance for Filing of Biologics License Application Resubmission for Sacituzumab Govitecan to Treat Metastatic Triple-Negative Breast Cancer

December 30, 2019

• Urovant Sciences Announces Submission of New Drug Application for Vibegron for the Treatment of Overactive Bladder
• MorphoSys Announces Submission of Biologics License Application for Tafasitamab in r/r DLBCL to the FDA