New Drug Applications Archive for 2013

January 3, 2013

• Merck Announces FDA Acknowledgement of Resubmission of New Drug Application for Ezetimibe/Atorvastatin Tablets

January 7, 2013

• Merck Announces FDA Acceptance of Resubmission of New Drug Application for Sugammadex Sodium Injection

January 8, 2013

• GE Healthcare Announces Acceptance of Applications for Review of Investigational Imaging Agent [18F]Flutemetamol in the United States and Europe

January 11, 2013

• FDA Advisory Committee Recommends Approval of Canagliflozin for Treatment of Adults with Type 2 Diabetes

January 14, 2013

• GSK Announces Submission of Albiglutide BLA to the US FDA for the Treatment of Type 2 Diabetes

January 15, 2013

• U.S. FDA Grants Priority Review to Boehringer Ingelheim's Afatinib NDA for EGFR Mutation-Positive Advanced NSCLC

January 16, 2013

• QRxPharma and FDA Establish Path Forward for Resubmission Of Moxduo New Drug Application

January 25, 2013

• FDA Issues Complete Response Letter for Rytary (Carbidopa and Levodopa) Extended-Release Capsules (IPX066) New Drug Application

January 28, 2013

• Genzyme's Lemtrada (alemtuzumab) Application for MS Accepted for Review by the FDA

January 30, 2013

• FDA Advisory Committee Recommends Approval for Boehringer Ingelheim's Olodaterol for Maintenance Treatment of COPD

February 5, 2013

• Hemispherx Biopharma Receives Complete Response Letter From FDA on Ampligen New Drug Application for Chronic Fatigue Syndrome

February 12, 2013

• Bayer Submits New Drug Application for Riociguat for the Treatment of Pulmonary Arterial Hypertension and Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension

February 15, 2013

• Medical Imaging Drugs Advisory Committee Recommends Approval of Guerbet NDA for Dotarem (gadoterate meglumine)

February 19, 2013

• GSK and Theravance Announce FDA Acceptance of New Drug Application Submission in the US for Anoro Ellipta for COPD
• Sanofi New Drug Application for Lixisenatide Accepted for Review by FDA

February 20, 2013

• Chelsea Therapeutics Receives FDA Guidance for a Northera (Droxidopa) NDA Resubmission With Study 306B

February 25, 2013

• Dynavax Receives FDA Complete Response Letter on Heplisav Biologic License Application

February 26, 2013

• AstraZeneca Announces Results From Long-Term Safety Trial Of Naloxegol In Patients With Opioid-Induced Constipation

February 27, 2013

• Zogenix Provides Update on Zohydro ER Regulatory Review
• AVEO and Astellas Announce FDA Advisory Committee To Review Tivozanib for the Treatment of Advanced Renal Cell Carcinoma
• Titan Pharmaceuticals Announces Date of FDA Advisory Committee Review of Probuphine for the Treatment of Opioid Dependence

February 28, 2013

• QRxPharma Resubmits MoxDuo New Drug Application to the FDA

March 4, 2013

• Depomed Provides Update on Sefelsa FDA Advisory Committee

March 6, 2013

• Noven Announces FDA Advisory Committee Vote on Investigational Low-Dose Mesylate Salt of Paroxetine (LDMP) for Vasomotor Symptoms Associated with Menopause

March 8, 2013

• Ceptaris Resubmits New Drug Application (NDA) to FDA for Proprietary Gel Formulation of Mechlorethamine Hydrochloride
• Sunovion Announces FDA Acceptance for Review of New Drug Application Resubmission for Stedesa (eslicarbazepine acetate) as a Once-Daily Adjunctive Therapy for Partial-onset Seizures in Adults with Epilepsy

March 14, 2013

• FDA Sets 26 August 2013 As New PDUFA Date For MoxDuo NDA

March 22, 2013

• pSivida Reports Updates on Iluvien for Planned Resubmission to FDA and European Launch

March 27, 2013

• Repros Reports Both Primary Endpoints Successfully Met in First Pivotal Study of Androxal

March 29, 2013

• Janssen Submits New Drug Application to U.S. FDA for Simeprevir (TMC435) for Combination Treatment of Adult Patients with Genotype 1 Chronic Hepatitis C
• Boehringer Ingelheim, Lilly Submit NDA for Empagliflozin
• A.P. Pharma Receives FDA Complete Response Letter for APF530

April 2, 2013

• pSivida Reports on Resubmission to FDA of NDA for Iluvien for Chronic Diabetic Macular Edema
• FDA Rejects A.P. Pharma's Cancer Drug

April 8, 2013

• Bayer's Investigational Riociguat Granted U.S. FDA Priority Review for Pulmonary Arterial Hypertension and Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension

April 9, 2013

• Gilead Submits New Drug Application to U.S. FDA for Sofosbuvir for the Treatment of Hepatitis C

April 16, 2013

• DURECT Announces Submission of New Drug Application for POSIDUR™ (SABER®-Bupivacaine)
• Allergan Receives Complete Response Letter from the U.S. Food and Drug Administration for Levadex (dihydroergotamine) New Drug Application

April 17, 2013

• FDA Advisory Committee Recommends Approval of Breo Ellipta for the Treatment of COPD

April 29, 2013

• Gilead Receives Complete Response Letters from U.S. Food and Drug Administration for Elvitegravir and Cobicistat
• Gilead Receives Complete Response Letters from U.S. Food and Drug Administration for Elvitegravir and Cobicistat

May 1, 2013

• Titan Pharmaceuticals Receives Complete Response Letter From the FDA for Probuphine New Drug Application
• Regulatory Update: Trametinib US PDUFA Date Extended to 3 September 2013
• Daratumumab Receives Breakthrough Therapy Designation in Double Refractory Multiple Myeloma from U.S. FDA

May 2, 2013

• AVEO and Astellas Report FDA Oncologic Drug Advisory Committee Votes Tivozanib Application Did Not Demonstrate Favorable Benefit-to-Risk Evaluation in Treatment of Advanced Renal Cell Carcinoma

May 13, 2013

• U.S. FDA Grants Priority Review to Simeprevir (TMC435) for Combination Treatment of Genotype 1 Chronic Hepatitis C

May 21, 2013

• Biogen Idec Submits Application to FDA for Approval of Plegridy (Peginterferon Beta-1a) in Multiple Sclerosis

May 22, 2013

• Merck Statement on FDA Advisory Committee Meeting for Suvorexant

May 28, 2013

• Valeant Pharmaceuticals Announces Receipt Of U.S. FDA Complete Response Letter For Efinaconazole

May 31, 2013

• Endo Pharmaceuticals Provides Regulatory Update On Aveed (Testosterone Undecanoate) Injection
• Vanda Announces Submission To FDA Of A New Drug Application For Tasimelteon For The Treatment Of Non-24-Hour Disorder In The Totally Blind

June 3, 2013

• FDA Issues Complete Response Letter on Sefelsa New Drug Application
• FDA Grants Soligenix "Fast Track" Designation for SGX942 for the Treatment of Oral Mucositis in Patients with Head and Neck Cancer

June 7, 2013

• Gilead Announces U.S. FDA Priority Review Designation for Sofosbuvir for the Treatment of Hepatitis C

June 10, 2013

• AVEO Announces Complete Response Letter Received for Tivozanib New Drug Application in Renal Cell Carcinoma
• Dynavax Reports Feedback From FDA Meeting Regarding Heplisav Biologic License Application

June 18, 2013

• IntelGenx Announces FDA Acceptance of NDA for Anti-Migraine VersaFilm

June 21, 2013

• Takeda Submits BLA for Vedolizumab for Moderately to Severely Active Crohn's Disease and Ulcerative Colitis

June 28, 2013

• FDA Issues Complete Response Letter for Xarelto (rivaroxaban) to Reduce the Risk of Stent Thrombosis in Patients with Acute Coronary Syndrome

July 1, 2013

• Bayer and Onyx Pharmaceuticals Announce Submission of FDA and EMA Applications for Nexavar (sorafenib) for the Treatment of Radioactive Iodine-Refractory Differentiated Thyroid Cancer
• Merck Receives Complete Response Letter for Suvorexant, Merck’s Investigational Medicine for Insomnia
• FDA Accepts the Filing of The Medicines Company's New Drug Application for Intravenous Antiplatelet Agent Cangrelor

July 9, 2013

• Chelsea Therapeutics Resubmits New Drug Application for Northera (droxidopa) for the Treatment of Symptomatic NOH
• United States Food and Drug Administration Accepts Trimel's NDA for CompleoTRT
• Omthera Pharmaceuticals Announces NDA Submission for Epanova for the Treatment of Patients with Very High Triglycerides

July 10, 2013

• New Drug Application Submitted to U.S. FDA for Ibrutinib in the Treatment of Two B-Cell Malignancies

July 11, 2013

• FDA Accepts Eliquis (apixaban) Supplemental New Drug Application for Review for Prophylaxis of Deep Vein Thrombosis Following Hip Or Knee Replacement Surgery

July 16, 2013

• Merck Statement on FDA Advisory Committee Meeting About Sugammadex Sodium Injection

July 17, 2013

• Chelsea Therapeutics Announces FDA Acceptance of Northera (droxidopa) NDA Resubmission

July 19, 2013

• US and EU Regulatory Authorities Accept Plegridy (peginterferon beta-1a) Marketing Applications for Review

July 24, 2013

• U.S. FDA Arthritis Advisory Committee Votes On Cimzia (certolizumab pegol) For Treatment of Adults with Active Axial Spondyloarthritis, Including Patients with Ankylosing Spondylitis
• Merck Announces FDA Acceptance of New Drug Application for Vorapaxar, Investigational Anti-Thrombotic Medicine
• Ligand Signs License Agreement with Ethicor for Oral Lasofoxifene

July 25, 2013

• Sarepta Therapeutics Announces Plans to Submit New Drug Application to FDA for Eteplirsen for the Treatment of Duchenne Muscular Dystrophy in First Half of 2014
• AstraZeneca and Bristol-Myers Squibb resubmit Dapagliflozin New Drug Application for the treatment of type 2 diabetes in the U.S

July 29, 2013

• Anacor Pharmaceuticals Announces That It Has Submitted a New Drug Application to the FDA for Tavaborole

August 2, 2013

• Theravance Announces FDA Advisory Committee to Review Anoro Ellipta (UMEC/VI) for COPD
• Regulatory Update: Albiglutide US PDUFA Date Extended by Three Months

August 6, 2013

• FDA Advisory Committee Unanimously Recommends Approval Of Bayer's Riociguat In Two Pulmonary Hypertension Indications

August 8, 2013

• Keryx Biopharmaceuticals Announces New Drug Application Submission for Zerenex for the Treatment of Hyperphosphatemia in Chronic Kidney Disease Patients on Dialysis

August 14, 2013

• MannKind Reports Positive Data from a Phase 3 Clinical Study of Afrezza in Patients with Type 1 Diabetes

August 15, 2013

• Chelsea Therapeutics Announces Submission of Additional Information for Northera NDA

August 21, 2013

• Data Published in the New England Journal of Medicine for Vedolizumab, an Investigational New Drug from Takeda for Moderately to Severely Active Ulcerative Colitis and Crohn's Disease

August 28, 2013

• QRxPharma Receives Complete Response Letter From FDA Regarding MoxDuo NDA

August 29, 2013

• New Drug Application Filing for Ibrutinib Accepted in Two B-cell Malignancies by the U.S. FDA

September 3, 2013

• Simultaneous Applications Submitted to FDA and EMA for Siltuximab for the Treatment of Multicentric Castleman Disease, a Rare Blood Disorder
• BHR Pharma Announces SyNAPSe® Trial Completes Patient Enrollment
• Totality of Data From Three Phase III Trials of The Medicines Company's Intravenous Cangrelor Presented and Published

September 4, 2013

• Takeda's New Investigational Drug Vedolizumab is Granted Priority Review Status by U.S. Food and Drug Administration for Ulcerative Colitis
• Chelsea Therapeutics Announces FDA Acceptance of Northera (droxidopa) NDA Resubmission

September 5, 2013

• FDA Accepts Endo's Complete Response Submission to New Drug Application for Aveed (Testosterone Undecanoate) Injection

September 9, 2013

• Merck Announces FDA Acceptance of New Drug Application for Investigational Fertility Treatment

September 10, 2013

• FDA Advisory Committee Recommends Approval in U.S. of Umeclidinium/Vilanterol for the Treatment of COPD
• FDA Advisory Committee to Review Anoro Ellipta NDA

September 11, 2013

• Gilead Submits New Drug Application to U.S. FDA for Idelalisib for the Treatment of Indolent Non-Hodgkin's Lymphoma

September 12, 2013

• Sanofi Provides Update on Lixisenatide New Drug Application in U.S.
• United Therapeutics Announces FDA Acceptance of Second Resubmission of Oral Treprostinil NDA

September 18, 2013

• FDA Accepts New Drug Application for Investigational Compound Epanova for the Treatment of Severe Hypertriglyceridemia

September 23, 2013

• Merck Receives Complete Response Letter for Investigational Medicine Sugammadex Sodium Injection

September 26, 2013

• Durata Therapeutics Announces NDA Submission for Dalbavancin for the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

September 30, 2013

• AcelRx Pharmaceuticals Submits New Drug Application to the FDA for Zalviso

October 3, 2013

• Anacor Pharmaceuticals Announces FDA Acceptance of Tavaborole NDA for Filing

October 8, 2013

• Keryx Biopharmaceuticals Announces FDA Acceptance for Filing of Zerenex New Drug Application

October 9, 2013

• Chelsea Therapeutics Announces FDA Advisory Committee to Review Northera

October 14, 2013

• MannKind Resubmits New Drug Application to U.S. FDA for Afrezza for the Treatment of Adults with Diabetes
• BioDelivery Sciences Announces FDA Acceptance of Bunavail NDA for Filing

October 18, 2013

• Alimera Sciences Receives Complete Response Letter For Iluvien

October 23, 2013

• Cubist Announces Submission of New Drug Application for Investigational Antibiotic Tedizolid for Treatment of Serious Skin Infections

October 24, 2013

• FDA Advisory Committee Recommends Approval of Simeprevir for Combination Treatment of Genotype 1 Chronic Hepatitis C in Adult Patients

October 25, 2013

• FDA Advisory Committee Supports Approval of Gilead’s Sofosbuvir for Chronic Hepatitis C Infection

November 5, 2013

• Aeterna Zentaris Submits New Drug Application to FDA for Macimorelin Acetate (AEZS-130) for Evaluation of AGHD

November 12, 2013

• Sarepta Therapeutics Announces FDA Considers NDA Filing for Eteplirsen Premature in Light of Recent Competitive Drug Failure and Recent DMD Natural History Data

November 13, 2013

• Paladin Announces Extension of the Impavido PDUFA Date by Three Months

November 15, 2013

• FDA Advisory Committee Recommends Approval of Hetlioz for the Treatment of Non-24-Hour-Disorder (Non-24) in the Totally Blind

November 19, 2013

• New Drug Application for Naloxegol Accepted by United States Food and Drug Administration

November 20, 2013

• FDA Advisory Committee Recommends Approval of Vimizim for Morquio A Syndrome

November 21, 2013

• Forest Laboratories and Gedeon Richter Receive Complete Response Letter for Cariprazine

November 25, 2013

• FDA Extends Review of Mallinckrodt’s NDA for Xartemis XR (oxycodone hydrochloride and acetaminophen) Extended-Release Tablets (CII)

November 26, 2013

• FDA Accepts for Review Purdue Pharma’s New Drug Application for Targiniq ER (oxycodone HCl/naloxone HCL Controlled-Release) Tablets CII
• Durata Therapeutics Announces FDA's Acceptance for Priority Review of NDA for Dalvance (dalbavancin hydrochloride)
• QRxPharma Refiles MoxDuo New Drug Application with the FDA

December 2, 2013

• Zalviso New Drug Application Accepted for Filing by FDA

December 9, 2013

• FDA Advisory Committee Recommends Approval of Takeda's Investigational Biologic Vedolizumab

December 10, 2013

• New Drug Application for Belinostat in Relapsed or Refractory PTCL Submitted to the FDA

December 11, 2013

• Sprout Pharmaceuticals Appeals FDA Decision on NDA for Flibanserin to Treat Hypoactive Sexual Desire Disorder in Premenopausal Women
• Orexigen Resubmits Contrave New Drug Application
• QRxPharma Announces 25 May 2014 as New PDUFA Date for MoxDuo NDA
• FDA Grants Priority Review for Genzyme’s Cerdelga (eliglustat), an Investigational Oral Therapy for Gaucher Disease

December 12, 2013

• FDA Advisory Committee Votes on Investigational Medicine Metreleptin
• FDA Issues Complete Response Letter for Canagliflozin/Metformin Fixed-Dose Combination Therapy for Type 2 Diabetes
• FDA Advisory Committee Recommends the Investigational SGLT2 Inhibitor Dapagliflozin for Treatment of Type 2 Diabetes in Adults

December 16, 2013

• AVEO Provides Update on Interim Analysis from Tivozanib Trial in Colorectal Cancer

December 17, 2013

• Ultragenyx Investigational New Drug Application for Triheptanoin for the Treatment of Glucose Transporter Type-1 Deficiency Syndrome is in Effect

December 30, 2013

• Genzyme Receives Complete Response Letter from FDA on Lemtrada (alemtuzumab) Application
• Veloxis Pharmaceuticals Announces NDA Submission for Envarsus in Kidney Transplant Recipients
• Cubist Announces FDA Acceptance of Tedizolid New Drug Application with Priority Review