New Drug Applications Archive for 2011
January 5, 2011
January 6, 2011
- Boceprevir, Merck's Investigational Oral Hepatitis C Protease Inhibitor, Receives FDA Priority Review and EMA Accelerated Assessment
- ChemGenex Announces alignment of European and US regulatory strategies for omacetaxine
January 7, 2011
January 10, 2011
- EffRx Pharmaceuticals SA Announces Submission of New Drug Application to FDA for Osteoporosis Treatment Targeting Increased Convenience for Patients
- Discovery Labs Provides Update Regarding Its Program for Surfaxin U.S. Marketing Authorization
January 11, 2011
January 12, 2011
- Pfizer Initiates Rolling Submission For A New Drug Application In The U.S. For Its Fast-Tracked Investigational Compound Crizotinib (PF-02341066) For Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer
- Fibrocell Science, Inc. Announces FDA Accepts for Review Complete Response Submission for Azficel-T
- FDA Agrees to Special Protocol Assessment (SPA) to Evaluate the Safety and Efficacy of a Fixed-Dose Combination (FDC) of Netupitant and Palonosetron in the Prevention of CINV
- K-V Pharmaceutical Company Updates Status of New Drug Application for Gestiva
January 13, 2011
January 18, 2011
January 19, 2011
January 20, 2011
- U.S. FDA and Health Canada Grant Priority Reviews for Telaprevir for the Treatment of Hepatitis C
- MannKind Corporation Receives Complete Response Letter from the FDA for Afrezza
- Adventrx Pharmaceuticals Receives PDUFA Date for Exelbine NDA
January 21, 2011
- VIVUS Provides Regulatory Update on Qnexa NDA
- AstraZeneca Replies to the US FDA Complete Response Letter for Brilinta (Ticagrelor Tablets)
January 24, 2011
January 25, 2011
January 27, 2011
February 1, 2011
- Discovery Labs Provides Expanded Update Regarding Its Program for Surfaxin U.S. Marketing Authorization
- FDA Issues Complete Response to New Drug Application for Contrave for the Management of Obesity
February 4, 2011
- US FDA Assigns New PDUFA Date for Brilinta (ticagrelor tablets)
- Obesity Society Disappointed by FDA Delay on Approval of Obesity Drug
February 24, 2011
February 25, 2011
February 28, 2011
- Shire Files Complete Response to FDA's Not Approvable Letter for Firazyr (icatibant) for the Treatment of Acute Attacks of Hereditary Angioedema
- Santarus and Pharming Announce Receipt of FDA Refusal to File Letter for Rhucin Biologics License Application
- Seattle Genetics Submits BLA to FDA for Brentuximab Vedotin in Relapsed or Refractory Hodgkin Lymphoma and Systemic ALCL
March 2, 2011
March 4, 2011
March 8, 2011
March 9, 2011
- Merck Announces FDA Acceptance of New Drug Application for Investigational Ophthalmic Medication Saflutan (tafluprost)
- FDA Advisory Committee Recommends US Approval of Novartis Once-Daily Bronchodilator QAB149 for COPD
March 18, 2011
March 21, 2011
April 4, 2011
April 6, 2011
April 8, 2011
April 13, 2011
April 18, 2011
- Lilly Receives Complete Response Letter From FDA for Liprotamase for the Treatment of Exocrine Pancreatic Insufficiency
- Regulatory Update - GSK and Valeant Respond to FDA on Ezogabine
April 25, 2011
April 28, 2011
April 29, 2011
- FDA Advisory Committee Unanimously Recommends Approval of Telaprevir for People with Hepatitis C
- Centocor Ortho Biotech Products, L.P. Voluntarily Withdraws NDA for Trabectedin
May 2, 2011
May 3, 2011
May 11, 2011
- New Drug Applications Submitted in the United States and Europe for Vemurafenib in Advanced Skin Cancer
- First EffRx NDA Accepted for Filing by the FDA
May 13, 2011
May 17, 2011
May 20, 2011
May 21, 2011
May 27, 2011
May 31, 2011
June 3, 2011
June 8, 2011
June 14, 2011
- Cell Therapeutics Completes Type A Meeting With FDA's Division of Oncology Drug Products: Guidance Provided for Resubmission of Pixantrone NDA for Consideration of Accelerated Approval
- Pacira Pharmaceuticals, Inc. Announces FDA Extension of Exparel PDUFA Target Date By Three Months
June 15, 2011
June 17, 2011
June 20, 2011
June 22, 2011
- Merck: Regulatory Update on Cladribine Tablets
- FDA Panel Endorses Efficacy but Not Safety of Novartis Drug ACZ885 for Gouty Arthritis; Did Not Support Approval in Proposed Indication
June 23, 2011
June 24, 2011
June 30, 2011
- VIVUS Submits New Drug Application for Avanafil for the Treatment of Erectile Dysfunction
- Forest and Almirall Announce Submission of New Drug Application for Aclidinium Bromide for the Treatment of Chronic Obstructive Pulmonary Disease (COPD)
July 7, 2011
July 13, 2011
July 15, 2011
- Transcept Pharmaceuticals Receives Complete Response Letter from FDA on Intermezzo New Drug Application
- Seattle Genetics Announces Unanimous Recommendations from FDA Advisory Committee in Favor of Accelerated Approval of Adcetris for Post-Transplant Relapsed Hodgkin Lymphoma and Relapsed or Refractory Systemic ALCL
July 19, 2011
July 20, 2011
July 26, 2011
July 28, 2011
- Bydureon Reply Submitted to FDA
- Yaupon Therapeutics, Inc. Submits New Drug Application for Proprietary Gel Formulation of Mechlorethamine Hydrochloride
July 29, 2011
August 1, 2011
August 2, 2011
August 3, 2011
August 5, 2011
- Alexza Announces Resubmission of AZ-004 (Staccato Loxapine) NDA
- Affymax and Takeda Announce FDA Acceptance of New Drug Application for Peginesatide
August 8, 2011
August 9, 2011
August 10, 2011
- Adventrx Receives Complete Response Letter for Exelbine NDA
- Bydureon FDA Action Date Set for January 28, 2012
August 11, 2011
- MAP Pharmaceuticals Issued U.S. Patent for Methods of Achieving Rapid Relief of Migraine and Minimizing Side Effects Based Upon Pharmacokinetic Profile
- Affymax Announces Assignment of March 27, 2012 PDUFA Date for Peginesatide New Drug Application
August 12, 2011
August 17, 2011
- Protalix BioTherapeutics Announces FDA Accepts for Review Complete Response Resubmission for Taliglucerase Alfa and Assigns PDUFA Date
- Regeneron Announces Review of Biologics License Application for Eylea (aflibercept injection) Extended by Three Months by FDA
August 18, 2011
August 19, 2011
August 24, 2011
August 26, 2011
August 29, 2011
- Astellas Pharma Inc.: Announcement of Regulatory Submission for Mirabegron (YM178), a Treatment for Overactive Bladder, in U.S. and Europe
- FDA Requests Additional Clinical Data on Novartis Drug ACZ885 for the Treatment of Gouty Arthritis
August 30, 2011
September 2, 2011
September 6, 2011
September 12, 2011
September 14, 2011
- ApoPharma Announces FDA Advisory Committee Recommendation in Favor of Ferriprox (deferiprone) Approval
- Transcept Pharmaceuticals Announces Plan to Resubmit Intermezzo New Drug Application Following Meeting with the U.S. Food & Drug Administration
September 20, 2011
September 23, 2011
September 26, 2011
September 28, 2011
October 3, 2011
October 4, 2011
October 5, 2011
October 7, 2011
October 12, 2011
- Onyx Pharmaceuticals Submits New Drug Application for Carfilzomib in Relapsed and Refractory Multiple Myeloma
- Discovery Labs Notified of PDUFA Date for Surfaxin
October 13, 2011
October 17, 2011
October 20, 2011
October 24, 2011
- Affymax Announces FDA Advisory Committee to Review Peginesatide
- Ironwood and Forest Announce Linaclotide New Drug Application for the Treatment of Irritable Bowel Syndrome with Constipation and Chronic Constipation Accepted for FDA Review
October 25, 2011
October 26, 2011
October 27, 2011
October 28, 2011
November 1, 2011
November 3, 2011
November 6, 2011
November 9, 2011
November 11, 2011
- Receipt of Filing Communication Letter from U.S. FDA Regarding Mirabegron (YM178)
- pSivida Reports Receipt by Alimera Sciences of Complete Response Letter from FDA for Iluvien for DME
- QRxPharma Granted Target Date for FDA Action on MoxDuo IR NDA: NDA Accepted for Review; PDUFA Date Set for June 25, 2012
November 18, 2011
November 28, 2011
November 29, 2011
- FDA Accepts Eliquis (apixaban) New Drug Application for Review for the Prevention of Stroke and Systemic Embolism in Patients with Atrial Fibrillation
- Onyx Pharmaceuticals Announces FDA Acceptance of New Drug Application for Carfilzomib for the Treatment of Relapsed and Refractory Multiple Myeloma
December 1, 2011
- Regulatory Update: Glaxosmithkline Submits Additional Information for Candidate Meningococcal and Hib Combination Vaccine
- NPS Pharmaceuticals Completes Submission of New Drug Application for Gattex (teduglutide) in Adult Short Bowel Syndrome (SBS)
December 6, 2011
December 7, 2011
December 8, 2011
December 13, 2011
December 14, 2011
December 15, 2011
- FDA Grants Priority Review for Kalydeco (ivacaftor), the First Potential Medicine to Target the Underlying Cause of Cystic Fibrosis
- FDA Extends Taliglucerase Alfa PDUFA Date to May 1, 2012
December 20, 2011
- Pfizer Announces FDA Acceptance for Review of New Drug Application for Tofacitinib for Adult Patients with Moderately to Severely Active Rheumatoid Arthritis
- Santarus Submits New Drug Application to FDA for Uceris (budesonide) Tablets
December 21, 2011
December 25, 2011
December 26, 2011
December 27, 2011
New drug applications archive
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
- 2011
- 2010
- 2009
- 2008
- 2007
- 2006
- 2005
- 2004
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.