New Drug Applications Archive for 2015

January 5, 2015

• Relypsa Announces October 21, 2015 as PDUFA Date for NDA for Patiromer for Oral Suspension

January 6, 2015

• Actavis and Gedeon Richter Announce FDA Receipt of NDA Resubmission for Cariprazine

January 7, 2015

• Sandoz Biosimilar Filgrastim Recommended for Approval

January 8, 2015

• Pfizer Provides Update on Ibrance (palbociclib)

January 9, 2015

• Sanofi and Regeneron Announce Positive Topline Results from Phase 3 Trials Evaluating Monthly Alirocumab

January 12, 2015

• Neos Therapeutics Announces Submission of NDA for its Methylphenidate Extended Release Oral Disintegrating Tablet (XR-ODT) for the Treatment of ADHD

January 19, 2015

• Marathon Pharmaceuticals Receives FDA Fast Track Designation for Deflazacort as a Potential Treatment for Duchenne Muscular Dystrophy

January 20, 2015

• Richter and Actavis Announce Positive Phase III Results for Cariprazine in the Prevention of Relapse in Patients with Schizophrenia

January 21, 2015

• UCB Announces US and EU Regulatory Filings for the Investigational Antiepileptic Drug Brivaracetam

January 22, 2015

• Astellas Announces FDA Anti-Infective Drugs Advisory Committee Recommends Approval of Cresemba (isavuconazonium)

January 26, 2015

• Sanofi and Regeneron Announce Praluent (alirocumab) BLA Accepted for Priority Review by FDA
• Insys Therapeutics Receives FDA Orphan Drug Designation for Its Liposomal Encapsulated Paclitaxel for the Treatment of Ovarian Cancer

January 30, 2015

• Phase II Trial of Anticancer Agent Lenvatinib in Renal Cell Carcinoma Meets Primary Endpoint

February 2, 2015

• Repros Submits New Drug Application to FDA for Androxal

February 3, 2015

• U.S. FDA Grants Priority Review for Yondelis (trabectedin) for the Treatment of Patients with Advanced Soft Tissue Sarcoma
• Genmab Announces Preliminary Results in Phase II Study of Daratumumab in Double Refractory Multiple Myeloma

February 9, 2015

• Hemispherx Biopharma Posts USAMRIID Ebola Study Concluding Ampligen Produced 100% Survival Rate in Rodents with 100% Mortality in Placebo
• Inspirion Delivery Technologies Announces FDA Acceptance of MorphaBond ER (morphine sulfate extended-release) NDA

February 11, 2015

• Oncolytics Biotech Inc. Announces Receipt of Orphan Drug Designation from FDA for Reolysin for Ovarian Cancer

February 12, 2015

• Lenvatinib Phase III Trial Results Published in New England Journal of Medicine
• Collegium Announces FDA Acceptance for Filing of NDA for Abuse-Deterrent Xtampza ER (oxycodone)

February 13, 2015

• Pfizer Announces FDA Acceptance for Review of NDA for ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride)
• Novartis' Heart Failure Medicine LCZ696 Granted FDA Priority Review

February 17, 2015

• Sprout Pharmaceuticals Resubmits Flibanserin NDA for Hypoactive Sexual Desire Disorder In Premenopausal Women
• Oncolytics Biotech Inc. Announces Receipt of Orphan Drug Designation from FDA for Reolysin for Pancreatic Cancer

February 18, 2015

• FDA Grants Genentech's Cobimetinib Priority Review for Use in Combination with Zelboraf in Advanced Melanoma

February 23, 2015

• Taiho Oncology, Inc. Announces TAS-102 NDA for Refractory Metastatic Colorectal Cancer Accepted for Review by FDA
• Endo Pharmaceuticals and BioDelivery Sciences Announce Acceptance of NDA for Belbuca (buprenorphine HCl) Buccal Film for Chronic Pain

February 26, 2015

• Otonomy Submits New Drug Application to the FDA for AuriPro

February 27, 2015

• LeafBio Announces Acceptance of Investigational New Drug (IND) Application for Ebola Therapy ZMapp

March 2, 2015

• Xadago (safinamide) NDA Accepted for Filing by the U.S. FDA
• Shire Submits NDA to the FDA for Approval of Lifitegrast For Treatment of Dry Eye Disease in Adults
• Boehringer Ingelheim Submits BLA to FDA for Idarucizumab, Investigational Specific Reversal Agent for Pradaxa

March 3, 2015

• Actelion's NDA for Selexipag (Uptravi) Accepted by the FDA

March 4, 2015

• FDA Accepts Bayer's BLA for Investigational Treatment Option in Hemophilia A

March 9, 2015

• AcelRx Provides Regulatory Update on Zalviso
• Kythera Biopharmaceuticals Announces FDA Advisory Committee Unanimously Recommends to Approve ATX-101

March 12, 2015

• BMS Announces Acceptance of NDA for Daclatasvir for FDA Review for Hepatitis C Genotype 3

March 13, 2015

• Merck Provides Regulatory Update on Investigational Medicine Sugammadex Injection

March 14, 2015

• New Detailed Data From Phase 3 Study Show Amgen's Repatha (Evolocumab) In Combination With Statins Reduced LDL-C By 67-76 Percent Compared To Placebo

March 15, 2015

• Sanofi and Regeneron Announce 18-Month Results of ODYSSEY LONG TERM Trial With Praluent (Alirocumab)
• Amgen Publishes Safety Analysis Of Investigational Cholesterol-Lowering Medication Repatha (Evolocumab)

March 19, 2015

• Sanofi Announces Top-Line Results for Cardiovascular Outcomes Study of Lyxumia (Lixisenatide)
• Nicox Receives Orphan Drug Designation from FDA for Naproxcinod in Duchenne Muscular Dystrophy

March 27, 2015

• Adamis Pharmaceuticals Receives Complete Response Letter From FDA For Its Epinephrine Pre-Filled Syringe NDA

April 7, 2015

• Gilead Submits NDA to FDA for Fixed-Dose Combination of Emtricitabine/Tenofovir Alafenamide for HIV

April 9, 2015

• U.S. FDA Grants Priority Review to Lifitegrast NDA for the Treatment of Dry Eye Disease in Adults

April 13, 2015

• Aeterna Zentaris Announces Plans to Initiate Phase 3 Study of Macrilen in AGHD
• ARCA Biopharma Receives FDA Fast Track Designation for Gencaro

April 15, 2015

• Repros Announces November 30, 2015 PDUFA Goal Date for Enclomiphene Citrate NDA
• FDA Advisory Committee Recommends Approval of The Medicines Company's Antiplatelet Therapy Cangrelor

April 17, 2015

• Results of Phase III Study of Brexpiprazole in Adult Patients With Schizophrenia Published in American Journal of Psychiatry
• Oncolytics Biotech Inc. Announces Receipt of Orphan Drug Designation from the FDA for Malignant Gliomas

April 23, 2015

• Ultragenyx Granted Additional Orphan Drug Designations for Triheptanoin
• FDA Grants Priority Review to Boehringer Ingelheim’s Biologics License Application for Idarucizumab

April 27, 2015

• Merrimack Pharmaceuticals and Baxter BioScience Announce Completion of NDA Submission for MM-398 as a Treatment for Post-Gemcitabine Metastatic Pancreatic Cancer
• BioMarin Completes Rolling NDA Submission to FDA for Drisapersen for Duchenne Muscular Dystrophy

April 28, 2015

• Otonomy Announces FDA Acceptance of AuriPro New Drug Application
• Merck Receives Complete Response Letter for Sugammadex Sodium Injection

April 29, 2015

• FDA Accepts BLA for Zinbryta (Daclizumab High-Yield Process) for Treatment of MS
• Amgen Announces FDA Advisory Committee Meeting to Review Repatha (Evolocumab) for High Cholesterol

May 4, 2015

• AcelRx Pharmaceuticals Provides Zalviso Regulatory Update

May 12, 2015

• FDA Advisory Panel Voted 12 to 1 to Recommend Approval of Orkambi (lumacaftor/ivacaftor) for Cystic Fibrosis F508del Mutation

May 21, 2015

• Tris Pharma Announces the FDA Acceptance of NDA for Dyanavel XR

May 26, 2015

• ZS Pharma Submits NDA for ZS-9 for the Treatment of Hyperkalemia

May 27, 2015

• FDA Accepts BPL’s Amended BLA Submission for Coagadex (Coagulation Factor X, Human)

May 28, 2015

• Merck Submits NDA for Grazoprevir/Elbasvir for Chronic Hepatitis C Genotypes 1, 4, and 6 Infection

June 1, 2015

• FDA Accepts Biologics License Application for Anthim (Obiltoxaximab)

June 2, 2015

• OPKO Announces Submission of Rayaldee NDA
• Dipexium Receives European Medicines Agency Scientific Advice on Clinical and Regulatory Pathway for Locilex

June 4, 2015

• FDA Advisory Committee Recommends Approval for Addyi (flibanserin) to Treat Hypoactive Sexual Desire Disorder in Premenopausal Women

June 5, 2015

• Janssen Initiates Rolling Submission of BLA for Daratumumab for the Treatment of Multiple Myeloma

June 6, 2015

• Lyxumia (Lixisenatide) Meets Co-Primary Endpoints in GetGoal Duo-2 Trial

June 8, 2015

• Titan Pharmaceuticals Reports Positive Results from Phase 3 Study of Probuphine for Opioid Addiction
• Sanofi's Lyxumia (lixisenatide) Demonstrated Cardiovascular Safety in People With Type 2 Diabetes and High CV Risk
• Repros Announces Date of FDA Advisory Committee Review of NDA

June 9, 2015

• FDA Advisory Committee Recommends Approval of Praluent (Alirocumab) Injection for Patients with Hypercholesterolemia
• Aripiprazole Lauroxil Phase 3 Schizophrenia Study Results Published in Journal of Clinical Psychiatry

June 10, 2015

• Santhera Update on Pre-NDA Meeting with FDA on Raxone®/Catena® in Duchenne Muscular Dystrophy (DMD)

June 11, 2015

• GSK Announces Outcome of US FDA Advisory Committee Recommending Approval of Mepolizumab for Severe Asthma
• InSite Vision Announces Completion of the NDA Submission for BromSite

June 15, 2015

• Chiasma Submits New Drug Application to U.S. FDA for Octreotide Capsules in Acromegaly

June 16, 2015

• Richter And Allergan Announce FDA Has Extended The Review Period For Cariprazine To September 2015

June 25, 2015

• U.S. FDA Grants Priority Review for MM-398 New Drug Application

June 29, 2015

• Sarepta Therapeutics Completes NDA Submission to FDA for Eteplirsen
• Intercept Pharmaceuticals Submits NDA for Obeticholic Acid for the Treatment of Primary Biliary Cirrhosis
• BioMarin Announces FDA Accepts Drisapersen NDA for Treatment of Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping

July 1, 2015

• Clovis Oncology Initiates Rolling NDA Submission for Rociletinib in Advanced EGFR-Mutant Non-Small Cell Lung Cancer
• Exelixis Provides Update on Genentech’s Pending NDA for Cobimetinib
• Gilead Submits NDA for Single Tablet Regimen for HIV Containing Rilpivirine, Emtricitabine and Tenofovir Alafenamide

July 6, 2015

• Ignyta Announces Collaboration with UCSF For Clinical Trial of Entrectinib
• Evofem, Inc. Submits NDA to U.S. FDA for Amphora as a Contraceptive

July 13, 2015

• Biofrontera Submits New Drug Application for Ameluz to FDA

July 15, 2015

• Takeda Submits NDA for Ixazomib for Patients with Relapsed/Refractory Multiple Myeloma

July 22, 2015

• FDA QIDP Designation for Motif’s Lead Antibiotic Candidate Iclaprim for ABSSSI
• Osmotica Announces OS-320 (Osmolex ER), Has Been Awarded Orphan Drug Status by the FDA

July 28, 2015

• FDA Accepts for Review CSL Behring’s BLA for Its Novel rVIII-SingleChain Therapy for Patients with Hemophilia A
• FDA Accepts OPKO's New Drug Application for Rayaldee
• Merck Announces FDA Acceptance of NDA for Grazoprevir/Elbasvir for Chronic Hepatitis C Genotypes 1, 4 and 6 Infection

July 29, 2015

• ZS Pharma Announces FDA Acceptance of ZS-9 New Drug Application
• Lightlake Therapeutics Inc. Announces Adapt Pharma Limited Submits NDA to FDA for Narcan (naloxone) Nasal Spray

August 3, 2015

• Clovis Oncology Submits NDA for Rociletinib for the Treatment of Advanced EGFR-Mutant T790M+ Non-small Cell Lung Cancer

August 5, 2015

• Marathon Pharmaceuticals to Begin NDA Process for Deflazacort as a Potential Treatment for Patients with Duchenne Muscular Dystrophy

August 6, 2015

• Adamis Pharmaceuticals Provides Regulatory Update on Its Epinephrine Pre-Filled Syringe

August 7, 2015

• Collegium Announces FDA Advisory Committee Meeting for Xtampza ER, an Abuse-Deterrent Analgesic for Chronic Pain

August 12, 2015

• Teva Announces FDA Acceptance of NDA for SD-809 for Treatment in Huntington Disease

August 17, 2015

• Chiasma Announces FDA Acceptance For Filing of New Drug Application for Octreotide Capsules in Acromegaly
• InSite Vision Announces FDA Acceptance of NDA Filing for BromSite (0.075% bromfenac)

August 19, 2015

• BioMarin Receives Rare Pediatric Disease Designation From FDA for Drisapersen for the Potential Treatment of Duchenne Muscular Dystrophy
• FDA Grants Fast Track Designation to Cempra for Solithromycin in the Treatment of Community Acquired Bacterial Pneumonia

August 21, 2015

• Alkermes Provides Update on FDA Review of Aristada for the Treatment of Schizophrenia

August 25, 2015

• Amgen Submits New Drug Application For Novel Intravenous Calcimimetic Etelcalcetide (AMG 416)
• Sarepta Therapeutics Announces FDA Has Filed Eteplirsen NDA for the Potential Treatment of Duchenne Muscular Dystrophy for Patients Amenable to Exon 51 Skipping

August 31, 2015

• FDA Grants Priority Review for Intercept's Obeticholic Acid for the Treatment of Primary Biliary Cirrhosis
• Lipocine Submits NDA to FDA for Its Oral Testosterone Replacement Product Candidate, LPCN 1021

September 1, 2015

• FDA Accepts for Priority Review the BLA for Empliciti (elotuzumab) for the Treatment of Multiple Myeloma

September 2, 2015

• Gilead’s Investigational Fixed-Dose Combination of Emtricitabine/Tenofovir Alafenamide (F/TAF) Meets Primary 48-Week Objective in Phase 3 Study

September 3, 2015

• FDA Grants Fast Track Designation for Iclaprim
• Acadia Pharmaceuticals Submits NDA for Nuplazid for the Treatment of Parkinson’s Disease Psychosis

September 4, 2015

• U.S. FDA Grants Priority Review to Janssen for Daratumumab as a Treatment for Multiple Myeloma

September 6, 2015

• Alexion Receives Notification of PDUFA Date Extension for Kanuma (sebelipase alfa)

September 8, 2015

• FDA Grants Genentech's Alectinib Priority Review for Specific Type of ALK-Positive Lung Cancer

September 9, 2015

• U.S. FDA Grants Priority Review to Takeda's Ixazomib for Patients with Relapsed/Refractory Multiple Myeloma

September 10, 2015

• Wellstat Therapeutics’ NDA for Uridine Triacetate as Antidote to Overexposure to Chemotherapy Drug 5-Fluorouracil (5-FU) Accepted for Review by FDA
• U.S. FDA Accepts First Digital Medicine New Drug Application for Otsuka and Proteus Digital Health

September 11, 2015

• Collegium Announces FDA Advisory Committees Unanimously Recommend Approval of Xtampza ER, an Abuse-Deterrent Analgesic for Chronic Pain
• FDA Accepts Filing of Ameluz and BFRhodoLED New Drug Application

September 14, 2015

• Sanofi Reports Positive Top-Line Results In Second Pivotal Lixilan Phase III Study

September 15, 2015

• Amicus Therapeutics Plans to Submit NDA for Migalastat for Fabry Disease Following Positive Pre-NDA Meeting With FDA

September 16, 2015

• FDA Accepts Scilex Pharmaceuticals' NDA Filing for ZTlido

September 17, 2015

• Experimental Ebola Treatment ZMapp is Granted Fast Track Status by the FDA

September 22, 2015

• Bausch+Lomb and Nicox Announce FDA Acceptance of NDA for Novel Glaucoma Candidate Vesneo (latanoprostene bunod)
• Evofem, Inc. Announces FDA Acceptance of New Drug Application for Amphora as a Contraceptive
• Kythera Biopharmaceuticals Submits Investigational New Drug Application for KYTH-105 to Treat Androgenetic Alopecia

September 23, 2015

• CTI BioPharma To Submit NDA For Pacritinib In Q4 Based Primarily On Data From Single Pivotal Persist-1 Trial

September 28, 2015

• Titan Pharmaceuticals Announces FDA's Acceptance of Resubmission of NDA for Probuphine
• Ocular Therapeutix Submits NDA for Dextenza for the Treatment of Post-Surgical Ocular Pain
• Osmotica Announces FDA Acceptance of Filing for Ontinua ER for Alleviation of Spasticity Resulting from Multiple Sclerosis

September 29, 2015

• Sanofi New Drug Application for Lixisenatide Accepted for Review by FDA

September 30, 2015

• Jazz Pharmaceuticals Announces FDA Acceptance for Filing with Priority Review of NDA for Defibrotide
• Xadago (safinamide) NDA Late-Cycle Review Meeting Completed with U.S. FDA

October 12, 2015

• Collegium Provides Update on FDA Review of Xtampza ER, an Abuse-Deterrent Analgesic for the Treatment of Chronic Pain

October 15, 2015

• BioMarin Announces FDA Advisory Committee to Review Drisapersen for Treatment of Patients With Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping

October 16, 2015

• AstraZeneca Receives Complete Response Letter for Saxagliptin/Dapagliflozin Fixed-Dose-Combination
• Shire Receives FDA Complete Response Letter for Lifitegrast NDA and Plans to Respond with OPUS-3 Trial

October 22, 2015

• Gilead Announces Phase 3 Results for Genvoya (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide), an Investigational Once-Daily Single Tablet Regimen for HIV

October 23, 2015

• FDA Advisory Committee Recommends the Approval of Lesinurad for Gout Patients

October 28, 2015

• Gilead Submits NDA to U.S. FDA for Fixed-Dose Combination of Sofosbuvir/Velpatasvir for Treatment of All Six Genotypes of Hepatitis C

October 29, 2015

• FDA Accepts for Filing Lipocine's NDA for Its Oral Testosterone Replacement Product Candidate, LPCN 1021
• Repros Therapeutics Announces Cancellation of FDA Advisory Committee Meeting to Review Enclomiphene for the Treatment of Secondary Hypogonadism

November 2, 2015

• Acadia Pharmaceuticals Announces FDA Priority Review of Nuplazid (Pimavanserin) NDA for Parkinson’s Disease Psychosis

November 6, 2015

• Merck Statement on FDA Advisory Committee Meeting for Bridion (sugammadex), Investigational Agent for the Reversal of Neuromuscular Blockade (NMB) Induced by Rocuronium or Vecuronium
• FDA Accepts Amgen's New Drug Application For Novel Intravenous Calcimimetic Etelcalcetide

November 9, 2015

• Collegium Announces FDA Tentative Approval for Xtampza ER, a Novel Abuse-Deterrent Analgesic for Chronic Pain
• Teva Announces Breakthrough Therapy Designation for SD-809 Granted by FDA for the Treatment of Tardive Dyskinesia

November 10, 2015

• Neos Therapeutics Receives Complete Response Letter From the FDA for Cotempla XR-ODT

November 12, 2015

• Lipocine Announces PDUFA Goal Date for LPCN 1021 NDA

November 15, 2015

• Clovis Oncology Announces U.S. and E.U. Regulatory Milestones for Rociletinib in the Treatment of Advanced EGFR-Mutant T790M+ Non-Small Cell Lung Cancer

November 16, 2015

• Clovis Oncology Announces Regulatory Update for Rociletinib NDA Filing

November 23, 2015

• CTI BioPharma Initiates Rolling Submission of NDA for Pacritinib for the Treatment of Patients with Myelofibrosis

November 25, 2015

• Amgen's First Biosimilar Biologics License Application for ABP 501 Submitted to FDA

December 1, 2015

• Repros Therapeutics Receives Complete Response Letter From FDA for Enclomiphene

December 2, 2015

• Fabre-Kramer Looks Forward to FDA's Decision on Gepirone ER for the Treatment of Major Depressive Disorder

December 6, 2015

• Pivotal Phase II Study Showed Nearly 80 Percent of People with Hard-to-treat Type of Chronic Lymphocytic Leukemia Responded to Investigational Medicine Venetoclax

December 7, 2015

• Adamis Pharmaceuticals Announces NDA Resubmission of Its Epinephrine Pre-Filled Syringe Application to the FDA

December 9, 2015

• Ocular Therapeutix Announces FDA Acceptance of NDA Filing for Dextenza for the Treatment of Post-Surgical Ocular Pain

December 10, 2015

• FDA Advisory Committee Recommends Approval of Teva’s Asthma Biologic Reslizumab

December 15, 2015

• Egalet Submits NDA for Arymo ER (Morphine Sulfate) Extended-Release Tablets
• Clovis Oncology Receives Notification of PDUFA Extension for Rociletinib

December 17, 2015

• Catalyst Pharmaceuticals Completes NDA Submission to FDA for Firdapse for the Treatment of Lambert-Eaton Myasthenic Syndrome and Congenital Myasthenic Syndromes
• FDA Extends PDUFA Date for Obeticholic Acid for the Treatment of PBC

December 18, 2015

• BioMarin Announces That FDA Has Advised it Will Not Take Action on the Kyndrisa (drisapersen) NDA by the PDUFA Date
• Portola Pharmaceuticals Completes BLA Submission to U.S. Food and Drug Administration for Andexanet Alfa

December 23, 2015

• Sanofi Submits NDA for Once-Daily Fixed-Ratio Combination of Insulin Glargine and Lixisenatide