New Drug Applications Archive for 2016

January 4, 2016

• Gilead Announces U.S. FDA Priority Review Designation for Sofosbuvir/Velpatasvir for Treatment of All Genotypes of Chronic Hepatitis C Infection

January 5, 2016

• CTI BioPharma and Baxalta Complete Submission of NDA for Pacritinib for Unmet Medical Need in Myelofibrosis

January 7, 2016

• Anacor Pharmaceuticals Submits NDA to the FDA for Crisaborole Topical Ointment, 2% for the Treatment of Mild-to-Moderate Atopic Dermatitis

January 8, 2016

• Sanofi and Regeneron Announce Sarilumab BLA Accepted for Review by FDA

January 12, 2016

• Gilead Submits New Drug Application to U.S. FDA for Tenofovir Alafenamide (TAF) for the Treatment of Chronic Hepatitis B
• Titan Pharmaceuticals And Braeburn Pharmaceuticals Announce FDA Advisory Committee Recommends Approval Of Probuphine
• FDA Grants Priority Review for Venetoclax New Drug Application

January 14, 2016

• FDA Issues Complete Response Letter for Kyndrisa for Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping
• Adamis Pharmaceuticals Announces FDA Acceptance of Resubmission of Its Epinephrine Pre-Filled Syringe NDA

January 15, 2016

• Heron Therapeutics Notified by FDA That It Will Not Take Action on Sustol New Drug Application by the PDUFA Date

January 19, 2016

• Lilly and Incyte Announce Submission of NDA to FDA for Oral Once-Daily Baricitinib for Treatment of Moderate-to-Severe Rheumatoid Arthritis

January 25, 2016

• FDA Accepts Amgen's Biosimilar Biologics License Application For ABP 501
• Shire Resubmits New Drug Application for Lifitegrast to U.S. FDA

January 26, 2016

• Valeant Announces FDA Acceptance of BLA Submission for Brodalumab in Moderate-to-Severe Plaque Psoriasis

January 29, 2016

• Synergy Pharmaceuticals Files NDA for Plecanatide in Chronic Idiopathic Constipation

February 4, 2016

• U.S. FDA Acknowledges Receipt of Resubmission of Shire’s NDA for Lifitegrast for Dry Eye Disease in Adults

February 8, 2016

• Sarepta Therapeutics Receives Notification of PDUFA Extension for Eteplirsen

February 9, 2016

• CTI BioPharma Provides Update on Clinical Hold of Investigational Agent Pacritinib and NDA
• FDA’s Arthritis Advisory Committee Recommends Approval of Celltrion’s CT-P13, a Proposed Biosimilar Infliximab

February 17, 2016

• Portola Pharmaceuticals Announces BLA for Andexanet Alfa Accepted for Review by FDA
• Catalyst Pharmaceuticals Receives Refusal to File Letter From the FDA on Its NDA for Firdapse

February 19, 2016

• Titan Pharmaceuticals Announces Notification of FDA Action Date Extension for Probuphine
• Spectrum Pharmaceuticals Announces FDA's Acceptance of NDA Filing for EOquin (apaziquone for intravesical instillation)

February 22, 2016

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

February 23, 2016

• PTC Receives Refuse to File Letter from FDA for Translarna (ataluren)

February 29, 2016

• Egalet Announces FDA Acceptance of New Drug Application for Arymo ER (Morphine Sulfate) Extended-Release Tablets

March 2, 2016

• First Patient Dosed in Iclaprim Phase 3 Trials to Treat Skin Infections

March 3, 2016

• Heron Therapeutics Provides Update on Sustol NDA

March 15, 2016

• Aralez Resubmits to FDA New Drug Application for Yosprala

March 17, 2016

• FDA Rules Favorably On Efficacy Of Travivo (Gepirone ER) For Treatment Of Major Depressive Disorder
• Elite Announces U.S. FDA Priority Review Designation for SequestOx NDA

March 22, 2016

• Anacor Pharmaceuticals Announces FDA Acceptance of NDA for Crisaborole Topical Ointment, 2% for the Treatment of Mild-to-Moderate Atopic Dermatitis

March 29, 2016

• Newron Receives Complete Response Letter from US FDA for Xadago (safinamide)
• FDA Advisory Committee Votes 12 to 2 That Benefits of Nuplazid (Pimavanserin) for the Treatment of Psychosis Associated with Parkinson’s Disease Outweigh the Risks
• Pain Therapeutics Resubmits Remoxy New Drug Application to the U.S. Food and Drug Administration

March 30, 2016

• Lexicon Submits New Drug Application to FDA for Telotristat Etiprate for the Treatment of Carcinoid Syndrome
• OPKO Receives Complete Response Letter from FDA for Rayaldee New Drug Application
• Shionogi Submits New Drug Applications in Japan and the U.S. for Naldemedine for the Treatment of Opioid-Induced Constipation
• Radius Health Submits NDA to the U.S. FDA for Abaloparatide-SC for the Treatment of Postmenopausal Women with Osteoporosis

April 10, 2016

• FDA Advisory Committee Unanimously Recommends Accelerated Approval of Ocaliva (obeticholic acid) for the Treatment of Primary Biliary Cirrhosis

April 12, 2016

• Clovis Oncology Provides Update on FDA Oncologic Drugs Advisory Committee Meeting to Review Rociletinib
• FDA Accepts Remoxy NDA for Review
• Merck Announces FDA Acceptance of Biologics License Application for Investigational House Dust Mite Sublingual Allergy Immunotherapy Tablet

April 15, 2016

• FDA Issues Complete Response Letter for Mycapssa New Drug Application

April 18, 2016

• Heron Therapeutics Provides Update on FDA Review of Sustol NDA

April 19, 2016

• Nicox submits New Drug Application for AC-170 to U.S. FDA
• Synergy Pharmaceuticals Announces Acceptance of NDA for Plecanatide, a Novel Uroguanylin Analog, in Chronic Idiopathic Constipation

April 22, 2016

• FDA Accepts Lundbeck Resubmission of New Drug Application for Carnexiv (carbamazepine)

April 25, 2016

• Sarepta Issues Statement on Advisory Committee Outcome for Use of Eteplirsen in the Treatment of Duchenne Muscular Dystrophy

April 26, 2016

• FDA Issues Complete Response Letter for Digital Medicine New Drug Application
• Catalyst Pharmaceuticals Provides Regulatory Update on Firdapse

April 27, 2016

• FDA Accepts Resubmission of New Drug Application for Rayaldee

May 1, 2016

• Cempra Completes NDA Submissions for Solithromycin in the Treatment of Community-Acquired Bacterial Pneumonia

May 4, 2016

• FDA Grants Priority Review For Lilly's Olaratumab, An Investigational Medicine For Advanced Soft Tissue Sarcoma

May 5, 2016

• Clovis Oncology Terminates Enrollment in all Ongoing Sponsored Clinical Studies of Rociletinib
• Statement Regarding FDA Advisory Committee Meeting on KemPharm’s Abuse-Deterrent Product Candidate Apadaz

May 20, 2016

• Acorda to Discontinue Development of Plumiaz (diazepam nasal spray) for Treatment of Epilepsy Seizure Clusters

May 23, 2016

• Merck Announces FDA Accepts Samsung Bioepis’ BLA for SB2 (infliximab), an Investigational Biosimilar of Remicade

May 24, 2016

• IDegLira Receives Positive 16-0 Vote in Favour of Approval from FDA Advisory Committee
• Allergan Announces FDA Acceptance of NDA Filing for Oxymetazoline HCI Cream 1.0%

May 25, 2016

• FDA Advisory Committee Recommends Approval of Sanofi Treatment for Adults With Type 2 Diabetes
• Sarepta Therapeutics Announces FDA Will Not Complete the Review of the Eteplirsen NDA By The PDUFA Date

May 26, 2016

• Flexion Therapeutics Receives Positive Guidance from FDA on NDA Submission for Zilretta for Osteoarthritis of the Knee

May 27, 2016

• AstraZeneca Receives Complete Response Letter from FDA for Sodium Zirconium Cyclosilicate (ZS-9) for Hyperkalemia

May 31, 2016

• Lexicon Announces FDA Priority Review of NDA for Telotristat Etiprate for the Treatment of Carcinoid Syndrome
• Radius Announces FDA Acceptance for Filing of NDA for Abaloparatide-SC for the Treatment of Postmenopausal Women with Osteoporosis
• Teva Receives Complete Response Letter for NDA for SD-809 for the Treatment of Chorea Associated with Huntington Disease
• FDA Grants Soligenix “Fast Track” Designation for SGX943 for the Treatment of Melioidosis

June 6, 2016

• Shionogi Announces Acceptance of NDA for Naldemedine for the Treatment of Opioid-Induced Constipation
• Sarepta Therapeutics Announces FDA Request For Dystrophin Data Prior To Making A Decision on Eteplirsen NDA
• Adamis Pharmaceuticals Receives Complete Response Letter From FDA For Its Epinephrine Pre-Filled Syringe NDA

June 7, 2016

• Teva Gains Recommendation for Approval from FDA Advisory Committees for Vantrela ER (hydrocodone bitartrate) Extended-Release Tablets

June 8, 2016

• Pfizer Announces FDA Advisory Committees’ Recommend ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride) Extended-Release Capsules for Approval

June 9, 2016

• Merck Statement on FDA Advisory Committee Meeting for Zinplava (bezlotoxumab), an Investigational Agent for Prevention of Clostridium difficile Infection Recurrence

June 13, 2016

• FDA Issues Complete Response Letter for Apadaz New Drug Application
• Charleston Laboratories, Inc. and Daiichi Sankyo, Inc. Announce FDA Acceptance of New Drug Application (NDA) for CL-108
• Amgen Announces FDA Advisory Committee Meeting To Review ABP 501, A Biosimilar Candidate To Adalimumab

June 14, 2016

• Marathon Pharmaceuticals Announces Submission of Deflazacort New Drug Application to the FDA

June 17, 2016

• ARIAD Initiates Submission of New Drug Application for Brigatinib to the U.S. FDA Ahead of Plan

June 21, 2016

• U.S. FDA grants Priority Review for Nicox’s AC-170 New Drug Application

June 22, 2016

• Mitsubishi Tanabe Pharma Submits New Drug Application for Edaravone to Treat ALS in the United States

June 27, 2016

• Medimetriks Pharmaceuticals, Inc. Submits NDA to FDA for Ozenoxacin Cream for Impetigo
• Advanced Accelerator Applications Announces FDA Priority Review for Lutathera

June 28, 2016

• FDA Grants Priority Review for Genentech’s Ocrevus (ocrelizumab) Biologics License Application

June 29, 2016

• Lipocine Receives Complete Response Letter (CRL) for LPCN 1021 From U.S. FDA

June 30, 2016

• Array BioPharma Submits Binimetinib New Drug Application to U.S. FDA

July 5, 2016

• Cempra Announces FDA Acceptance of Solithera New Drug Applications in the Treatment of Community-Acquired Bacterial Pneumonia

July 7, 2016

• TherapeuticsMD Announces New Drug Application Submission for Yuvvexy (TX-004HR)

July 12, 2016

• Amgen To Discuss Data Supporting Biologics License Application For ABP 501, A Biosimilar Candidate To Adalimumab

July 15, 2016

• Synergy Pharmaceuticals Provides Update on Ongoing FDA Review of Plecanatide CIC NDA and IBS-C Clinical Development Program
• FDA Issues Complete Response Letter For SequestOx New Drug Application

July 19, 2016

• FDA Advisory Committee Recommends Approval Of Brodalumab For Treatment Of Moderate-To-Severe Plaque Psoriasis

July 21, 2016

• Merck Provides Regulatory Update on Biologics Licensing Application for Investigational Agent Bezlotoxumab
• Amgen and UCB Submit Biologics License Application for Romosozumab to the FDA
• Puma Biotechnology Submits New Drug Application for PB272 (Neratinib) to FDA for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer

July 22, 2016

• Valeant Pharmaceuticals Receives FDA Complete Response Letter for Latanoprostene Bunod

July 25, 2016

• Ocular Therapeutix Receives Complete Response Letter from FDA for its NDA for Dextenza for the Treatment of Post-Surgical Ocular Pain

July 26, 2016

• Newron to Re-Submit US NDA for Xadago (safinamide)

July 27, 2016

• FDA Accepts BLA for BioMarin’s Cerliponase Alfa for CLN2 Disease, Form of Batten Disease

August 4, 2016

• Egalet Announces FDA Advisory Committees Recommend Approval of Abuse-Deterrent Arymo ER (Morphine Sulfate)

August 5, 2016

• Merck Announces U.S. FDA Filing Acceptance of New Drug Application (NDA) for MK-1293, an Investigational Follow-On Biologic Insulin Glargine

August 8, 2016

• Pfizer Announces Publication of New Analysis Showing Long-Term Therapy with Vyndaqel (tafamidis) Slowed Progression of Rare Neurodegenerative Disease

August 10, 2016

• FDA Accepts Marathon Pharmaceuticals’ NDA for Deflazacort for the Treatment of Duchenne Muscular Dystrophy

August 18, 2016

• FDA Grants Soligenix Orphan Drug Designation for Dusquetide for Treatment of Macrophage Activation Syndrome
• Portola Pharmaceuticals Receives Complete Response Letter from FDA for Biologics License Application for AndexXa (andexanet alfa)

August 20, 2016

• Zealand Announces New Timelines for a U.S. FDA Decision on iGlarLixi, the Fixed-Ratio Combination of Lixisenatide (Adlyxin) and Lantus, for the Treatment of Type 2 Diabetes

August 23, 2016

• FDA Accepts Clovis Oncology’s NDA for Rucaparib for Priority Review for the Treatment of Advanced Mutant BRCA Ovarian Cancer

August 24, 2016

• Amgen Provides Update on Status of Parsabiv (Etelcalcetide) NDA Submitted to the U.S. FDA

August 29, 2016

• Neurocrine Submits New Drug Application for Valbenazine for Treatment of Tardive Dyskinesia

August 30, 2016

• FDA Accepts Mitsubishi Tanabe Pharma's NDA Filing for Edaravone to Treat ALS
• FDA Accepts CSL Behring's BLA for First Subcutaneous Prophylactic Therapy CSL830 to Prevent Hereditary Angioedema Attacks
• ARIAD Completes Rolling Submission of NDA for Brigatinib to the U.S. FDA

August 31, 2016

• Neurocrine Announces FDA Conditional Acceptance of Proprietary Name Ingrezza for VMAT2 Inhibitor Valbenazine

September 1, 2016

• Kamada and Kedrion Seek FDA Approval of Human Rabies Immunoglobulin as a Post-Exposure Treatment
• Array BioPharma Announces FDA Acceptance of Binimetinib NDA for Patients with Advanced NRAS-Mutant Melanoma

September 2, 2016

• FDA Extends Regulatory Review Period for IDegLira by Three Months

September 6, 2016

• BioMarin Announces Update to Brineura (cerliponase alfa) Program for Treatment of CLN2 Disease, a Form of Batten Disease
• Aerie Pharmaceuticals Submits NDA to U.S. FDA for Rhopressa (netarsudil ophthalmic solution) 0.02%

September 12, 2016

• Tesaro Receives FDA Fast Track Designation for Niraparib and Initiates Rolling NDA Submission

September 14, 2016

• FDA Extends PDUFA Date for Telotristat Etiprate for the Treatment of Carcinoid Syndrome
• FDA Advisory Committee Votes that Qapzola (apaziquone) Has Not Shown Substantial Evidence of a Treatment Effect Over Placebo

September 19, 2016

• TherapeuticsMD Announces FDA Acceptance of New Drug Application (NDA) and Prescription Drug User Fee Act (PDUFA) Date for Yuvvexy (TX-004HR)

September 20, 2016

• Puma Biotechnology Announces FDA Acceptance of NDA for PB272 (Neratinib) for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer

September 22, 2016

• Newron Re-Submits US NDA for Xadago (safinamide)

September 23, 2016

• Janssen Submits Application Seeking Approval of Sirukumab in United States for Rheumatoid Arthritis

September 26, 2016

• Biogen Completes Rolling Submission of New Drug Application to FDA for Nusinersen as a Treatment for Spinal Muscular Atrophy
• Amgen And UCB Announce U.S. FDA Acceptance Of Biologics License Application For Romosozumab
• Sanofi and Regeneron Announce Dupilumab Biologics License Application Accepted for Priority Review by U.S. FDA
• Pain Therapeutics Receives Complete Response Letter for Remoxy ER

October 3, 2016

• Jazz Pharmaceuticals Initiates Rolling NDA Submission for Vyxeos (CPX-351) Expects to Complete NDA Submission by Early 2017

October 4, 2016

• Dynavax Provides Regulatory Update on Heplisav-B

October 10, 2016

• Nicox Receives Complete Response Letter from the FDA Related to GMP on NDA for AC-170

October 11, 2016

• Neurocrine Announces Ingrezza (valbenazine) NDA for the Treatment of Tardive Dyskinesia has been Accepted for Priority Review by FDA

October 13, 2016

• Sunovion Announces FDA Filing Acceptance of New Drug Application for SUN-101/eFlow® for the Treatment of Patients with Chronic Obstructive Pulmonary Disease (COPD)
• Egalet Notified that FDA Will Not Meet PDUFA Goal Date for Arymo ER

October 17, 2016

• PTC Therapeutics Provides Regulatory Update on Translarna (ataluren) for Nonsense Mutation Duchenne Muscular Dystrophy

October 18, 2016

• FDA Accepts for Review New Drug Application for Sodium Zirconium Cyclosilicate (ZS-9) for the Treatment of Hyperkalemia

October 20, 2016

• Teva Announces FDA Acceptance of Resubmitted NDA for SD-809 for Treatment of Chorea Associated with Huntington Disease

October 21, 2016

• US FDA Considers Newron’s Re-Submitted NDA for Xadago to be a Complete, Class 2 Response to Complete Response Letter

October 24, 2016

• Melinta Therapeutics Submits Baxdela New Drug Application for Hospital-Treated Skin Infections

October 25, 2016

• Portola Pharmaceuticals Submits NDA to U.S. FDA for Betrixaban for Extended Duration Prophylaxis of Venous Thromboembolism in Acute Medically Ill Patients

October 26, 2016

• Aeterna Zentaris Completes Patient Recruitment for Confirmatory Phase 3 Trial of Macrilen

October 27, 2016

• Adamas Submits New Drug Application to U.S. FDA for ADS-5102 for the Treatment of Levodopa-induced Dyskinesia in Patients with Parkinson's Disease

October 28, 2016

• Biogen’s Regulatory Applications for Nusinersen as a Treatment for Spinal Muscular Atrophy Accepted by FDA and EMA
• Sanofi and Regeneron Receive Complete Response Letter from FDA for Sarilumab, an Investigational Treatment for Rheumatoid Arthritis

October 31, 2016

• ARIAD Announces U.S. Food and Drug Administration Acceptance of NDA Filing for Brigatinib

November 1, 2016

• Tesaro Announces Submission of Niraparib NDA For Platinum-sensitive, Recurrent Ovarian Cancer

November 4, 2016

• FDA Advisory Committee Votes That Efficacy Results of Cempra's Solithromycin Outweigh Risks for Community-Acquired Bacterial Pneumonia

November 8, 2016

• Emmaus’ New Drug Application for Sickle Cell Disease Accepted for Review by FDA

November 14, 2016

• Dynavax Receives Complete Response Letter from U.S. FDA for Biologics License Application for Heplisav-B

November 15, 2016

• Amgen and Allergan Submit Biosimilar BLA for ABP 215 to U.S. FDA

November 17, 2016

• Spectrum Pharmaceuticals Receives Complete Response Letter from FDA for Qapzola
• Neos Therapeutics Submits NDA for Amphetamine Extended-Release Liquid Suspension Drug Candidate, NT-0201, for the Treatment of ADHD
• Janssen Submits Application to FDA Seeking Approval of Anti-Interleukin-23 Monoclonal Antibody Guselkumab for the Treatment of Moderate to Severe Plaque Psoriasis

November 18, 2016

• Apricus Biosciences Provides Update on Vitaros NDA Following Receipt of FDA Feedback

November 21, 2016

• GSK Files Regulatory Submission in US for Once-Daily Closed Triple Combination Therapy FF/UMEC/VI for Patients with COPD

November 25, 2016

• Intellipharmaceutics Submits NDA for Rexista (oxycodone hydrochloride extended release), an Abuse Deterrent Opioid Analgesic for the Treatment of Moderate to Severe Pain

November 28, 2016

• Amicus Therapeutics Announces U.S. Regulatory Pathway for Migalastat for Fabry Disease

November 29, 2016

• FDA Accepts the BLA for Avelumab for the Treatment of Metastatic Merkel Cell Carcinoma for Priority Review
• Neurocrine Announces FDA Advisory Committee Meeting to Review Ingrezza (valbenazine) NDA for the Treatment of Tardive Dyskinesia

December 5, 2016

• Novo Nordisk Files for Regulatory Approval of Once-Weekly Semaglutide with the FDA for the Treatment of Type 2 Diabetes

December 8, 2016

• Gilead Submits NDA to FDA for the Investigational Single Tablet Regimen Sofosbuvir/Velpatasvir/Voxilaprevir
• Catalyst Pharmaceuticals Provides Update on its Clinical Trial for Patients with Congenital Myasthenic Syndromes

December 9, 2016

• Synergy Pharmaceuticals Announces Positive Results in First Phase 3 Trial of Plecanatide in Patients with Irritable Bowel Syndrome with Constipation (IBS-C)
• US FDA Accepts First Biologics License Application for AstraZeneca’s Durvalumab in Bladder Cancer

December 12, 2016

• Flexion Therapeutics Submits New Drug Application for Zilretta to Treat Knee Osteoarthritis Pain

December 13, 2016

• AcelRx Pharmaceuticals Submits New Drug Application for ARX-04 for the Treatment of Moderate-To-Severe Acute Pain

December 16, 2016

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

December 19, 2016

• AbbVie Submits NDA to FDA for its Investigational Regimen of Glecaprevir/Pibrentasvir (G/P) for the Treatment of All Major Genotypes of Chronic Hepatitis C

December 20, 2016

• FDA Extends Review of Application for Ocrevus (ocrelizumab)
• Neos Therapeutics Completes Resubmission of NDA for Cotempla XR-ODT for the Treatment of ADHD
• Tesaro Announces Priority Review Designation for Niraparib NDA

December 21, 2016

• Advanced Accelerator Applications Receives Complete Response Letter from FDA for Lutathera, an Investigational Treatment for Neuroendocrine Tumors
• Antares Pharma Announces Submission of New Drug Application for Quickshot Testosterone

December 22, 2016

• Elite Provides Update On SequestOx New Drug Application

December 23, 2016

• Portola Pharmaceuticals Announces FDA Accepts NDA for Priority Review for Oral, Factor Xa Inhibitor Anticoagulant Betrixaban

December 29, 2016

• Cempra Receives Complete Response Letter From FDA For Solithromycin NDAs