Medication Guide App

New Drug Applications Archive

Get news by email or subscribe to our news feeds.

All News Consumer Pharma New Drugs Pipeline Clinical Trials

News Archive for November 2009

November 2, 2009

Dendreon Completes Submission of Biologics License Application for Provenge
GTx Receives Complete Response Letter from FDA for Toremifene 80 mg New Drug Application

November 4, 2009

FDA Grants Priority Review for Shire's velaglucerase alfa for Type 1 Gaucher Disease
InterMune Announces Submission of NDA for Pirfenidone for the Treatment of Patients with IPF

November 5, 2009

Theratechnologies' NDA for Tesamorelin to be Reviewed by an FDA Advisory Committee

November 10, 2009

ChemGenex Announces FDA Accepts NDA for Omapro (Omacetaxine Mepesuccinate) and Grants the Filing Priority Review Status

November 13, 2009

Cadence Pharmaceuticals Announces FDA Extends New Drug Application Review for Intravenous Acetaminophen by Three Months

November 16, 2009

November 17, 2009

Genzyme Receives Complete Response Letter on Lumizyme Application

November 18, 2009

NicOx announces FDA accepts naproxcinod NDA for filing

November 19, 2009

AstraZeneca Submits US New Drug Application for ticagrelor (Brilinta), an Investigational Antiplatelet Agent

November 22, 2009

Dendreon Receives FDA Acknowledgement of Complete Response for Provenge

November 23, 2009

FDA has posted an Advisory Committee meeting with Photocure to discuss Hexvix NDA

November 24, 2009

Transcept Pharmaceuticals Scheduled to Meet With FDA to Discuss Intermezzo Complete Response Letter

November 25, 2009

Human Genome Sciences Submits Biologics License Application to FDA for Zalbin

November 30, 2009

Merck KGaA Receives Refuse to File Letter from FDA on Cladribine Tablets New Drug Application

New Drug Applications Archive

2013

January, February, March, April, May

2012

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

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

FDA Consumer Updates

More FDA updates...

Recently Approved

Nymalize Nymalize (nimodipine) is a calcium channel blocker indicated to improve neurological outcome following...
Breo Ellipta Breo Ellipta (fluticasone and vilanterol) is a once-a-day inhaled corticosteroid / long-acting beta2 agonist...
Liptruzet Liptruzet (atorvastatin and ezetimibe) is a statin (HMG-CoA reductase inhibitor) and cholesterol absorption...
Procysbi Procysbi (cysteamine bitartrate) is a cystine depleting agent indicated for the treatment of nephropathic...
Kcentra

Get Updates by Email

Email me:

Drugs.com Pill Reminder

Support

About Drugs.com

Your Privacy

Follow: Google+ Facebook Twitter YouTube

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

Data sources include Micromedex™ (updated Apr 24th, 2013), Cerner Multum™ (updated Apr 19th, 2013), Wolters Kluwer™ (updated Apr 30th, 2013) and others. To view content sources and attributions, refer to our editorial policy.

Copyright © 2000-2013 Drugs.com. All rights reserved.

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

Terms of Use · Privacy Policy

Advertisement

Recommended

Symptom Checker

(web2)