New Drug Applications Archive for 2014

January 6, 2014

• Aeterna Zentaris NDA for Macimorelin Acetate in AGHD Accepted for Filing by the FDA

January 7, 2014

• Orexigen Announces June 10, 2014 PDUFA Action Date for Contrave

January 8, 2014

• Daiichi Sankyo Submits Savaysa (edoxaban) New Drug Application to the U.S. FDA

January 13, 2014

• U.S. FDA Accepts New Drug Application for Gilead’s Idelalisib for the Treatment of Refractory Indolent Non-Hodgkin’s Lymphoma
• Clarus Therapeutics Submits New Drug Application for Rextoro (formerly CLR-610) for the treatment of Low Testosterone

January 14, 2014

• FDA Advisory Panel Recommends Approval of Chelsea Therapeutics' Northera (Droxidopa) for the Treatment of Symptomatic nOH

January 15, 2014

• Merck Statement on FDA Advisory Committee for Vorapaxar, Merck’s Investigational Antiplatelet Medicine

January 27, 2014

• Heron Therapeutics Provides Update on Sustol Resubmission
• Medac Pharma, Inc. Secures FDA Acceptance of a New Drug Application (NDA) for Methotrexate-Containing Autopen

January 28, 2014

• Merck Statement on FDA Advisory Committee Meeting for Ragwitek™ (Short Ragweed Pollen Allergen Extract), an Investigational Sublingual Allergy Immunotherapy Tablet
• Cell Therapeutics Announces GOG Completes Patient Enrollment in GOG-0212 Phase 3 Clinical Trial of Paclitaxel Poliglumex (Opaxio™) as Maintenance Therapy in Ovarian Cancer

January 30, 2014

• Avanir Pharmaceuticals Announces Submission of New Drug Application for AVP-825 for the Acute Treatment of Migraine

February 6, 2014

• Spectrum Pharmaceuticals Announces FDA's Acceptance of NDA Filing for Beleodaq (belinostat) for Injection, a novel pan-HDAC inhibitor

February 7, 2014

• Alcobra Announces IND Submission for Extended Release Metadoxine to Treat Adults With ADHD

February 10, 2014

• Gilead Files for U.S. Approval of Ledipasvir/Sofosbuvir Fixed-Dose Combination Tablet for Genotype 1 Hepatitis C

February 11, 2014

• Melinta Therapeutics Raises $70 Million to Support Delafloxacin NDA and Selection of Multi-Drug Resistant Gram-Negative Candidates from RX-04 Platform
• Sprout Pharmaceuticals Receives Clear Guidance from FDA on Path Forward to Resubmit NDA for Flibanserin

February 12, 2014

• FDA Advisory Committee Recommends Against Antiplatelet Therapy Cangrelor

February 14, 2014

• Nicox to re-focus Naproxcinod on Duchenne Muscular Dystrophy
• Chelsea Therapeutics Issues Statement Regarding Postponement of Northera NDA PDUFA Date

February 15, 2014

• AVEO and Astellas to End Worldwide Collaboration & License Agreement for Tivozanib

February 20, 2014

• FDA Accepts Filing of NDA for IV Antibiotic Oritavancin with Priority Review

February 24, 2014

• XOMA Receives Orphan Drug Designation From U.S. FDA for Pyoderma Gangrenosum

February 25, 2014

• BioCryst Announces Peramivir NDA Acceptance by the FDA
• InterMune Reports Phase 3 ASCEND Trial Results of Pirfenidone in Idiopathic Pulmonary Fibrosis (IPF)

February 27, 2014

• Forest Laboratories Submits NDA for Nebivolol and Valsartan Combination in Hypertension

March 3, 2014

• FDA Grants Fast Track Designation to Naurex's Rapid-Acting Novel Antidepressant GLYX-13

March 4, 2014

• XOMA Provides Update on Gevokizumab Proof-of-Concept Program
• Forest Submits NDA for Memantine ER and Donepezil Fixed-Dose Combination for Alzheimer’s Disease

March 5, 2014

• U.S. Food and Drug Administration Issues Complete Response Letter for Empagliflozin

March 13, 2014

• FDA Accepts NDA for Envarsus for the Prevention of Organ Rejection in Kidney Transplant Patients

March 20, 2014

• NDA for Orphan Drug Ryanodex Accepted By FDA

March 24, 2014

• Rockwell Medical Submits NDA for Triferic
• Scilex Pharmaceuticals Announces Filing of Investigational New Drug Application for Ztilido

March 26, 2014

• Avanir Pharmaceuticals Announces Acceptance of NDA for AVP-825 for the Acute Treatment of Migraine

March 27, 2014

• pSivida Announces Resubmission of New Drug Application for Iluvien

March 31, 2014

• FDA Advisory Committee Unanimously Recommends Approval of Dalvance (dalbavancin)
• FDA Advisory Committee Unanimously Recommends Approval of Sivextro (tedizolid phosphate)

April 1, 2014

• Janssen Submits NDA for a Fixed-Dose Combination of Darunavir with Cobicistat

April 2, 2014

• FDA Advisory Committee Recommends Approval of Afrezza - Investigational Drug to Treat Diabetes

April 4, 2014

• Ventrus Biosciences Receives Date for Type B Pre-NDA Meeting With FDA for Dolizem

April 7, 2014

• Bristol-Myers Squibb Submits NDAs for Daclatasvir and Asunaprevir to US FDA for the Treatment of Hepatitis C
• Gilead Announces FDA Priority Review Designation for Ledipasvir/Sofosbuvir Fixed-Dose Combination
• MannKind Updates Status of New Drug Application for Afrezza

April 11, 2014

• Impax Pharmaceuticals Resubmits NDA for Rytary (Carbidopa and Levodopa) Extended-Release

April 14, 2014

• Bristol-Myers Squibb Submits NDA to FDA for Fixed-Dose Combination of Atazanavir Sulfate with Cobicistat
• Alimera Sciences Announces New PDUFA Date For Iluvien
• Boehringer Ingelheim and Eli Lilly Announce NDA Filing for Empagliflozin and Linagliptin Combination

April 21, 2014

• Sarepta Therapeutics Announces Plans to Submit NDA to FDA for Eteplirsen for Duchenne Muscular Dystrophy
• Gilead Sciences’ New Drug Application for Cobicistat for HIV Therapy Accepted by U.S. FDA
• Gilead Sciences’ New Drug Application for Elvitegravir for HIV Therapy Accepted by U.S. FDA

April 22, 2014

• AbbVie Submits NDA to FDA for Oral, Interferon-Free Therapy for the Treatment of Hepatitis C
• QRxPharma Issues Statement On Moxduo Advisory Committee Meeting

April 23, 2014

• Cubist Announces Submission of NDA for Investigational Antibiotic Ceftolozane/tazobactam

April 30, 2014

• The Medicines Company Receives Complete Response Letter From FDA for Antiplatelet Agent Cangrelor

May 2, 2014

• FDA Issues Complete Response Letter for Plumiaz (diazepam nasal spray) for Epilepsy Cluster Seizures

May 15, 2014

• Scilex Pharmaceuticals Initiates Pivotal Pharmacokinetic Study for Ztilido

May 16, 2014

• Shire Plans to Submit a New Drug Application to FDA for Lifitegrast for Dry Eye Disease in Adults
• Pfizer To Submit Palbociclib New Drug Application With FDA Based On Final Results Of PALOMA-1
• InterMune Announces Expanded Access Program for Pirfenidone to Treat Idiopathic Pulmonary Fibrosis (IPF) in the United States

May 22, 2014

• Keryx Receives Notification of PDUFA Date Extension for Zerenex

May 27, 2014

• InterMune Announces Resubmission Of NDA For Pirfenidone For The Treatment Of Patients With IPF

May 28, 2014

• Rockwell Medical Announces FDA Acceptance for Filing of Triferic New Drug Application

May 29, 2014

• Adamis Submits New Drug Application to FDA for Its Epinephrine Pre-Filled Syringe
• Safinamide New Drug Application (NDA) Submitted to the U.S. Food and Drug Administration (FDA)

June 3, 2014

• Prosensa Announces Regulatory Path Forward for Drisapersen as a Potential Treatment for DMD

June 6, 2014

• Cubist Announces Publication of Pivotal Data from Sivextro (tedizolid phosphate) ESTABLISH-2 Trial

June 10, 2014

• Tonix Pharmaceuticals Receives IND Clearance From FDA for TNX-102 in Post-Traumatic Stress Disorder

June 11, 2014

• FDA Advisory Committee to Discuss Peripherally-Acting Opioid Receptor Antagonists

June 14, 2014

• Sanofi's Lyxumia (lixisenatide) Showed More Pronounced After-Test-Meal Blood Sugar Lowering than Liraglutide when Both were Added to Insulin Glargine

June 16, 2014

• DARA BioSciences' KRN5500 Granted Orphan Drug Designation by FDA for Treatment of Multiple Myeloma

June 17, 2014

• Boehringer Ingelheim and Eli Lilly and Company Announce Resubmission of NDA for Empagliflozin to FDA
• FDA Accepts New Drug Application for Symplmed’s Prestalia for the Treatment of Hypertension

June 24, 2014

• FDA Accepts Merck’s NDA for Fixed-Dose Combination of Raltegravir with Lamivudine

June 25, 2014

• FDA Advisory Committee Votes on Accelerated Approval for Investigational Medicine Olaparib

June 30, 2014

• Merck’s Investigational Anti-PD-1 Antibody, Pembrolizumab, Under Regulatory Review in Europe for Advanced Melanoma

July 1, 2014

• Amgen Receives FDA Breakthrough Therapy Designation For Investigational BiTE Antibody Blinatumomab In Acute Lymphoblastic Leukemia

July 2, 2014

• U.S. FDA Accepts NDA Filing for Boehringer Ingelheim’s Nintedanib for Idiopathic Pulmonary Fibrosis

July 8, 2014

• FDA Accepts Sanofi's New Drug Application for Basal Insulin Toujeo

July 9, 2014

• Astellas Submits NDA for Isavuconazole Invasive Aspergillosis and Invasive Mucormycosis

July 14, 2014

• Otsuka and Lundbeck Submit NDA for Brexpiprazole

July 16, 2014

• Boehringer Ingelheim’s Investigational Therapy Nintedanib Receives FDA Breakthrough Therapy Designation

July 17, 2014

• InterMune Receives FDA Breakthrough Therapy Designation for Pirfenidone, an Investigational Treatment for IPF

July 21, 2014

• Medicines360 and Actavis Announce FDA Acceptance for Filing of NDA for Levosert IUD

July 23, 2014

• Lightlake Therapeutics Inc. Files Investigational NDA For Naloxone Nasal Spray For Reversing Opioid Overdose

July 25, 2014

• AcelRx Pharmaceuticals Receives Complete Response Letter from FDA for NDA for Zalviso

July 29, 2014

• Merck Receives Complete Response Letter from the U.S. FDA for New Drug Application for Corifollitropin Alfa
• FDA Accepts for Review Adamis’ New Drug Application for Its Epinephrine Pre-Filled Syringe
• Refusal to File Letter Received from US FDA for Safinamide, Based on Organization and Navigation Problems

August 18, 2014

• Pfizer Announces Submission of Palbociclib New Drug Application to the FDA

August 19, 2014

• Boehringer Ingelheim Announces U.S. Filing for the Fixed-Dose Combination Tiotropium Plus Olodaterol

August 21, 2014

• Palbociclib Expanded Access Program Now Open To Eligible U.S. Patients With HR+, HER2- Advanced Breast Cancer

August 27, 2014

• FDA Grants Amgen Priority Review Designation For Ivabradine For The Treatment Of Chronic Heart Failure

August 28, 2014

• Amgen Submits BLA For Novel Investigational LDL Cholesterol-Lowering Medication Evolocumab

August 30, 2014

• Novartis' new heart failure medicine LCZ696 cut cardiovascular deaths by 20% vs. ACE-inhibitor in landmark PARADIGM-HF trial

September 2, 2014

• Actavis Announces FDA Acceptance for Filing of NDA for Eluxadoline
• Merck to Present New Data in Five Tumor Types from Studies Evaluating Pembrolizumab

September 8, 2014

• Tesaro Announces Submission of Rolapitant NDA to U.S. Food and Drug Administration

September 10, 2014

• BioCryst Announces Rapivab (peramivir injection) Trial Results for the Treatment of Influenza

September 11, 2014

• FDA Advisory Committee Votes 14-1 in Favor of Saxenda (liraglutide) for Obesity

September 15, 2014

• FDA accepts Tuzistra XR (CCP-01) NDA for full review

September 22, 2014

• Amgen Submits BLA for Investigational BiTE® Immunotherapy Blinatumomab

September 24, 2014

• FDA Accepts Filing for Review of Brexpiprazole

September 26, 2014

• Bristol-Myers Squibb Announces Multiple Regulatory Milestones for Opdivo (nivolumab)

October 6, 2014

• Chimerix Announces Emergency Investigational NDA for Brincidofovir Authorized by FDA for Patients With Ebola Virus Disease
• BMS Announces Collaboration to Evaluate Opdivo (nivolumab) in Combination to Treat Non-Small Cell Lung Cancer

October 9, 2014

• Amgen's BiTE® Immunotherapy Blinatumomab Receives FDA Priority Review Designation In Acute Lymphoblastic Leukemia

October 10, 2014

• Prosensa Begins NDA Submission for Drisapersen to treat Duchenne Muscular Dystrophy

October 13, 2014

• Pfizer Announces FDA Acceptance Of Palbociclib New Drug Application With Priority Review

October 15, 2014

• U.S. FDA Grants Priority Review Status to NDA for Anticancer Agent Lenvatinib

October 20, 2014

• FDA Advisory Committee Recommends Approval of Secukinumab for Plaque Psoriasis

October 21, 2014

• U.S. FDA Accepts Filing Of NDA for Empagliflozin/Metformin Fixed-Dose Combination

October 22, 2014

• Relypsa Submits NDA for Patiromer for Oral Suspension to Treat Hyperkalemia

October 27, 2014

• Pfizer to Discontinue Agreement on Remoxy (oxycodone) Extended-Release Capsules CII
• Sarepta Therapeutics Announces Regulatory Update on Eteplirsen

October 30, 2014

• Phase 2 Objective Response Rate and Survival Data for Opdivo (nivolumab) in NSCLC to be Presented
• Avanir Pharmaceuticals Announces Publication of Pivotal Phase III Results from AVP-825 Acute Migraine Study

October 31, 2014

• FDA Advisory Committee Recommends Savaysa (edoxaban) for Reduction of Embolic Events in Non-Valvular Atrial Fibrillation
• Veloxis Announces Tentative Approval of Envarsus XR

November 3, 2014

• Basilea reports granting of U.S. orphan drug designation to isavuconazole for the treatment of invasive candidiasis

November 5, 2014

• GSK Announces Regulatory Submissions for Mepolizumab in Severe Eosinophilic Asthma
• Vertex Submits NDA for Lumacaftor in Combination with Ivacaftor for Cystic Fibrosis F508del Mutation

November 6, 2014

• Novartis Announces Outcome of FDA Advisory Committee Meeting for LBH589 (Panobinostat)
• FDA Issues Complete Response Letter for Macrilen (macimorelin) NDA in Adult Growth Hormone Deficiency

November 7, 2014

• Avanir Pharmaceuticals Announces Preliminary Feedback from the FDA on AVP-825 for the Acute Treatment of Migraine

November 10, 2014

• Novartis to present first IL-17A Phase III data for AIN457 (secukinumab) in Psoriatic Arthritis and Ankylosing Spondylitis
• FDA Accepts Amgen's BLA For LDL Cholesterol-Lowering Medication Evolocumab

November 13, 2014

• Chimerix's Brincidofovir Selected for Use in Ebola Clinical Trial in West Africa

November 16, 2014

• Study Comparing Opdivo (nivolumab) to Chemotherapy Demonstrates Survival Benefit

November 17, 2014

• Nine New Analyses Show Novartis' LCZ696 Could Change Course of Heart Failure for Patients

November 24, 2014

• Janssen Submits NDA for Yondelis (trabectedin) for Advanced Soft Tissue Sarcoma

November 26, 2014

• Avanir Pharmaceuticals Receives Complete Response Letter (CRL) from FDA on AVP-825 NDA

December 5, 2014

• Anti-Infective Advisory Committee Recommends Approval Of Actavis' Ceftazidime-Avibactam

December 6, 2014

• Opdivo (nivolumab) Demonstrates High Overall Response Rate of 87% for Treatment of Relapsed or Refractory Hodgkin Lymphoma

December 9, 2014

• Hemispherx Announces Data Showing Inhibition of Ebola by Ampligen Enlarged by Howard University Research

December 11, 2014

• Jazz Pharmaceuticals Initiates Rolling NDA Submission For Defibrotide For The Treatment Of Severe Hepatic Veno-Occlusive Disease

December 14, 2014

• Genentech Submits NDA to FDA for Investigational Cobimetinib Used in Combination with Zelboraf (vemurafenib) in Advanced Melanoma

December 15, 2014

• Relypsa Announces FDA Acceptance of New Drug Application for Patiromer for Oral Suspension to Treat Hyperkalemia
• Collegium Pharmaceutical Submits NDA for Xtampza ER (oxycodone) Abuse-Deterrent Analgesic
• Pfizer Announces Palbociclib PALOMA-1 Data Published in The Lancet Oncology

December 17, 2014

• Pozen’s Yosprala Receives Complete Response Letter from the FDA

December 23, 2014

• Actelion Submits NDA for Selexipag (Uptravi) in Patients with Pulmonary Arterial Hypertension
• PTC Therapeutics Begins Rolling NDA Submission to the FDA for Translarna to Treat Duchenne Muscular Dystrophy

December 24, 2014

• Actavis Confirms Complete Response Letter for Nebivolol/Valsartan Fixed-Dose Combination for Hypertension

December 29, 2014

• Ignyta Receives Orphan Drug Designation and Rare Pediatric Disease Designation for Entrectinib
• Safinamide NDA Re-Submitted to the U.S. FDA

December 30, 2014

• Alexion Completes Rolling BLA Submission to FDA for Asfotase Alfa for Hypophosphatasia