Skip to Content
Browse all medications
A
B
C
D
E
F
G
H
I
J
K
L
M
N
O
P
Q
R
S
T
U
V
W
X
Y
Z
Advanced
Phonetic
Search:
Drugs A-Z
Complete A - Z Drug Index
Drugs by Condition
Drugs by Class
Drug Side Effects
Drug Dosage
Pregnancy Warnings
Breastfeeding Information
International Drugs
Generic Drugs
Veterinary Drugs
Natural Products
Phonetic Search
Harvard Health Topics
Medical Encyclopedia
Pill Identifier
Interactions Checker
News / Alerts
FDA Medwatch Drug Alerts
FDA Labeling Changes
Daily MedNews for Consumers
Pharmaceutical Industry News
Clinical Trial News
New Drug Approvals
New Drug Applications (Pipeline)
Get News via RSS
Get News via Twitter
Drugs.com Blog
Health Professionals
Professional Resource Center
FDA Prescribing Information
AHFS DI Monographs
A-Z Drug Facts for the Professional
Drug Interactions Checker
Patient CareNotes for the Professional
Natural Products Database
Medical Conferences
Pharmaceutical Company Directory
Medical Dictionary
Phonetic Drug Search
Community
Ask Medical Questions
Join Support Groups
Forum - Discussion Boards
Mednotes
Apps
Home
›
News
›
New Drug Application Pipeline
› Archive
New Drug Applications Archive
Get news
By email
or subscribe to our
News feeds
.
All News
Consumer
Pharma
New Drugs
Pipeline
Clinical Trials
July 2007
July 2
Warner Chilcott and LEO Pharma Announce NDA Submission for Taclonex Scalp Gel
Sciele Pharma Submits Supplemental New Drug Application to FDA for New Sular Formulation
Spectrum Pharmaceuticals Completes the NDA Filing for Isovorin
July 6
Wyeth to File for FDA Approval of Tygacil for the Treatment of Patients with Community-Acquired Pneumonia
July 9
MGI Pharma and Helsinn Announce Aloxi sNDA for PONV Accepted for Review By U.S. FDA
July 12
Sucampo Pharmaceuticals Submits Supplemental New Drug Application for Lubiprostone to Treat Irritable Bowel Syndrome With Constipation
July 13
Encysive Pharmaceuticals Provides Update for Thelin (Sitaxsentan Sodium)
July 17
Salix Pharmaceuticals Announces Submission of Balsalazide Tablet New Drug Application
July 18
Abilify (aripiprazole) Supplemental New Drug Application Receives Priority Review by U.S. Food And Drug Administration for Adjunctive Treatment in Adults With Major Depressive Disorder
Neurochem Receives Approvable Letter for Eprodisate (Kiacta) for Treatment of AA Amyloidosis
U.S. FDA and European EMEA Accept Registration Applications for Ceftobiprole, Novel Anti-MRSA Broad-Spectrum Cephalosporin
New Drug Application for Investigational HIV Treatment TMC125 Submitted to U.S. Food and Drug Administration
July 19
DOR BioPharma, Inc. Announces 3 Month Extension of FDA PDUFA Action Date for orBec New Drug Application to Review Supplemental Data
Committee for Medicinal Products for Human Use Post-authorisation Summary of Positive Opinion for Acomplia/Zimulti
July 20
Abbott Submits E.U. and U.S. Regulatory Filings for New Lower-Strength Kaletra and Aluvia (lopinavir/ritonavir) Tablet Suitable for Pediatric Use in HIV/AIDS
Biovail Provides Update on BVF-033
July 23
IDM Pharma Announces Plans to Amend New Drug Application for Mifamurtide (L-MTP-PE) for the Treatment of Patients with Osteosarcoma
QLT Announces FDA Filing and Review of Aczone Labeling Supplement for Removal of Blood Screening Requirement
July 24
Wyeth Receives Approvable Letter from FDA for Pristiq for the Treatment of Vasomotor Symptoms Associated with Menopause
July 25
A.T.S. Pharmaceuticals, A division of Auriga Laboratories Launches Xyralid LP Lotion
New Study Confirms Link Between Breast Cancer and Hormone Therapy
Oncologic Drugs Advisory Committee Recommends FDA Wait for Overall Survival Analysis of Satraplatin for Treatment of Hormone-Refractory Prostate Cancer
July 26
Kuvan Receives Priority Review Status from FDA
July 30
GPC Biotech Withdraws Satraplatin NDA for Accelerated Approval; Plans to Resubmit With Survival Analysis
D.C. Denies Prostate Cancer Vaccine, Provenge: Dendreon (WA) Not FDA To Blame
July 31
Lev Pharmaceuticals Submits Biologics License Application for Cinryze
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
FDA Medwatch Drug Alerts
FDA Drug Safety Labeling Changes
Daily MedNews
Pharma Industry News
New Drug Approvals
Clinical Trial Results
Generic Drug Approvals
Monthly Update Archive
Search:
Sign In
or
Register
Username
Password
Forgot password?
FDA Consumer Updates
Primatene Mist With Chlorofluorocarbons No Longer Available After Dec. 31, 2011
HCG Diet Products are Illegal
Lock it Up: Medicine Safety in Your Home
Reducing Fever in Children: Safe Use of Acetaminophen
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 ...
More...
Get Updates by Email
Email me:
FDA Medwatch Alerts
News Roundup
Daily
Weekly
Monthly
Email
(web6)