NDA

Drugmakers Debate Whether Parts of FDA’s Biosimilar Guidance are Unconstitutional
RAPS.org
Thu, 02/14/19 - 05:46 pm
FDA
biosimilars
BLA
NDA
Sunovion Receives Bad News From the FDA About ADHD Drug
CP Wire
Fri, 08/31/18 - 10:45 am
Sunovion
CRL
NDA
dasotraline
ADHD
FDA
complete response letter
Navidea Biopharmaceuticals Posts Lymphoseek® NDA Update to Company Website
Wed, 10/10/12 - 07:46 pm
Navidea Biopharmaceuticals
NDA
Lymphoseek
Gentium Announces NDA Submission for Defibrotide
Yahoo
Wed, 07/6/11 - 08:15 am
Gentium
NDA
Defibrotide
FDA
veno-occlusive disease
Merck Reports FDA Acceptance of NDA for Janumet
Bloomberg
Tue, 01/11/11 - 12:41 pm
Merck
FDA
Janumet
NDA
diabetes
AstraZeneca: FDA Extends Vandetanib NDA Review Timeline To April 7
WSJ Online
Fri, 01/7/11 - 10:07 am
FDA
NDA
vandetanib
AstraZeneca
Cadence to Re-file Application
Yahoo/Zacks.com
Fri, 04/23/10 - 11:54 am
Cadence Pharmaceuticals
Ofirmev
NDA
Bristol-Myers Squibb
FDA Accepts VIAject NDA for Review
Yahoo
Mon, 03/1/10 - 09:53 am
Biodel
Viaject
NDA
FDA
Jazz files NDA for fibromyalgia treatment
Bizjournals.com
Thu, 02/18/10 - 08:49 pm
Jazz Pharmaceuticals
NDA
fibromyalgia
Lannett to Submit NDA for Morphine Sulfate Products
Trading Markets
Sat, 02/6/10 - 12:40 pm
Lannett
NDA
morphine sulfate
New Year’s Resolution for Biopharma: Submit Better NDAs
InVivo
Tue, 01/5/10 - 09:11 am
NDA
drug development
It's Time for Adventrx to Follow Through on NDA
Seeking Alpha
Wed, 12/30/09 - 09:50 am
NDA
Adventrx
AstraZeneca submits Brilinta NDA to FDA
Marketwatch
Thu, 11/19/09 - 09:07 am
NDA
FDA
Brilinta
AstraZeneca
Stats show weakness in Q4 NDAs
Fierce Pharma
Wed, 09/16/09 - 04:27 pm
NDA
FDA
Adeona Prepares Three Drugs for NDA Submission
Offical Wire
Fri, 09/4/09 - 07:46 am
NDA
FDA
Adeona
Trimesta
MS
Zinthionein
macular degeneration
JP1
rheumatoid arthritis
FDA Accepts Pozen's NDA For Vimovo - Update
RTT News
Mon, 08/31/09 - 08:33 am
Pozen
NDA
FDA
Vimovo
arthritis
King Provides Additional Information on the REMOXY(R) NDA Resubmission Plan
Yahoo
Tue, 07/7/09 - 04:16 pm
King
FDA
Remoxy
NDA
Sepracor's STEDESA (Eslicarbazepine Acetate) New Drug Application Formally Accepted for Review by the FDA
Yahoo
Mon, 06/1/09 - 08:30 am
FDA
Sepracor
Stedesa
epilepsy
NDA
Warner Chilcott Announces FDA Acceptance of NDA Submission for Low Dose Oral Contraceptive
Yahoo
Wed, 05/27/09 - 10:34 pm
Warner Chilcott
FDA
NDA
birth control pill
A.P. Pharma Submits New Drug Application for APF530 in Chemotherapy-Induced Nausea and Vomiting
Yahoo
Mon, 05/18/09 - 09:34 am
AP Pharma
FDA
NDA
APF530

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