New Drug Applications Archive

Get news By email or subscribe to our News feeds.

All News Consumer Pharma New Drugs Pipeline Clinical Trials

August 2007

August 1

Joint FDA Advisory Committee Recommends Approval of Tysabri for the Treatment of Moderate to Severe Crohn's Disease

August 2

FDA Issues Second Approvable Letter for Trexima Discovery Labs Provides Update On Progress for Surfaxin for RDS

August 3

Jazz Pharmaceuticals, Inc. Announces Submission of Complete Responses to FDA Approvable Letters for Luvox CR and Luvox

August 6

SkyePharma PLC - Flutiform Progress Update

August 7

The Medicines Company Submits Angiomax (Bivalirudin) sNDA to Expand Label to Include Acuity Data Orenica (abatacept) Supplemental Biologics License Application for Juvenile Idiopathic Arthritis Accepted by FDA for Filing and Review Encysive Pharmaceuticals Files Request for Formal Dispute Resolution With U.S. FDA to Contest Third Approvable Letter for Thelin

August 8

Rilonacept (IL-1 Trap) Granted FDA Priority Review for the Treatment of CAPS GSK Receives Decision From FDA on Advair 500/50 for COPD

August 10

Wyeth Pharmaceuticals and Solvay Pharmaceuticals, Inc. Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia

August 14

GlaxoSmithKline's Application for Rotarix is Accepted for Review by the FDA

August 15

GlaxoSmithKline Updates Prescribing Information for Avandia

August 16

Sciele Pharma Announces FDA Acceptance of NDA for Summers Laboratories' Head Lice Treatment

August 17

Indevus Receives Approvable Letter From FDA for Valstar for Bladder Cancer Therapy UCB Announces Submission of Lacosamide Marketing Application for Diabetic Neuropathic Pain Endo and Vernalis Provide Update on Frova

August 20

Nexavar Granted FDA Priority Review for Treatment of Liver Cancer Harvard Medical School-Partners HealthCare Center for Genetics and Genomics Successfully Completes Evaluation of AutoGenomics 2C9-VKORC1 Panel to Assess Warfarin Sensitivity Solvay Pharmaceuticals, Inc. Receives Approvable Letter from FDA with Respect to New Drug Application for Creon

August 21

Daiichi Sankyo and Forest Laboratories Sign Letter of Intent for Co-Promotion of Azor

August 22

Neurocrine Announces PDUFA Action Date of December 12, 2007 for Indiplon Capsules FDA Advisory Panel to Review Medtronic's Endeavor Drug Eluting Stent in October

August 24

Genentech Announces Resubmission of Supplemental Biologics License Application for Avastin in Combination with Paclitaxel for First-Line Metastatic Breast Cancer

August 27

IDM Pharma Receives Not Approvable Letter for Mifamurtide (L-MTP-PE) for the Treatment of Osteosarcoma

August 28

Indevus Announces Submission of New Drug Application for Nebido Schering-Plough/Merck Pharmaceuticals Announce FDA Filing Acceptance of New Drug Application for Loratadine/Montelukast Tablet FDA Accepts for Review Complete Response to Approvable Letter for Entereg (alvimopan) for POI Neurochem Provides Information on Cash Position

August 29

Merck Announces FDA Acceptance of NDA for Cordaptive (ER niacin/laropiprant), Formerly Known as MK-0524A, an Investigational Lipid-Modifier

August 30

Cardiome And Astellas Announce Regulatory Extension

New Drug Applications Archive

2012

January, February

2011

January, February, March, April, May, June, July, August, September, October, November, December

2010

January, February, March, April, May, June, July, August, September, October, November, December

2009

January, February, March, April, May, June, July, August, September, October, November, December

2008

January, February, March, April, May, June, July, August, September, October, November, December

2007

January, February, March, April, May, June, July, August, September, October, November, December

2006

January, February, March, April, May, June, July, August, September, October, November, December

2005

January, February, March, April, May, June, July, August, September, October, November, December

2004

January, February, March, April, May, June, July, August, September, October, November, December

More News Resources

Sign In or Register

Forgot password?

FDA Consumer Updates

More FDA Updates...

Recently Approved

Mitosol
Mitosol (mitomycin) is an antimetabolite indicated as an adjunct to ab externo glaucoma surgery.
Sklice
Sklice (ivermectin) Lotion is a pediculicide indicated for the topical treatment of head lice infestations in ...
Jentadueto
Jentadueto (linagliptin and metformin) is a dipeptidyl peptidase-4 (DPP-4) inhibitor and biguanide ...
Kalydeco
Kalydeco (ivacaftor) is a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator indicated ...
Erivedge
Erivedge (vismodegib) is a hedgehog pathway inhibitor for the treatment of patients with advanced basal cell ...

Get Updates by Email

Email me:

Support

About Drugs.com

Your Privacy

Follow us on: Google+ Facebook Twitter

Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines & natural products. This material is provided for educational purposes only and is not to be used for medical advice, diagnosis or treatment.

Data sources include Micromedex™ (updated Jan 27th, 2011), Cerner Multum™ (updated Jan 3rd, 2012), Wolters Kluwer™ (updated Jan 31st, 2012) and others.
To view content sources and attributions, refer to our editorial policy.

Copyright © 2000-2012 Drugs.com. All rights reserved.

We comply with the HONcode standard for trustworthy health information.
Verify here

Terms of Use · Privacy Policy

(web6)