Looking Forward: Significant Products With
2010 Action Goal Dates
|
|
New molecular entities, novel biologics and
other significant submissions with PDUFA goal dates
falling in 2010, as selected by Pharmaceutical
Approvals Monthly
|
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Sponsor/Product
|
Use
|
User Fee Goal
Date
|
|
February
|
|
GlaxoSmithKline/Xenoport
Horizant (gabapentin
enacarbil)
|
Restless leg
syndrome
|
2/9/2010
("Complete response" letter announced
2/17/2010)
|
|
Shire
VPRIV (velaglucerase
alfa)
|
Gaucher
disease
|
2/28/2010
|
|
March
|
|
Amylin/Lilly/Alkermes exenatide
sustained-release
|
Once-weekly form
of the antidiabetic
Byetta
|
3/5/2010
|
|
ChemGenex
Omapro (omacetaxine)
|
Chronic myeloid
leukemia (Gleevec
failures)
|
3/8/2010
|
|
Shionogi
glycopyrrolate
|
Chronic drooling
due to neurologic disorders
|
3/28/2010 or
earlier (if priority)
|
|
Theratechnologies
Egrifta (tesamorelin)
|
HIV-associated
lipodystrophy
|
3/29/2010
|
|
April
|
|
Kamada alpha-1
antitrypsin intravenous
|
Alpha-1
antitrypsin deficiency
|
2Q
2010
|
|
Cell Therapeutics
pixantrone
|
Non-Hodgkin's
lymphoma
|
4/23/2010
|
|
Sepracor
(Dainippon Sumitomo)/BIAL Stedesa
(eslicarbazepine)
|
Partial onset
seizures
|
4/30/2010
|
|
May
|
|
Bristol-Myers
Squibb belatacept
|
Renal
transplantation
|
5/1/2010
|
|
Dendreon
Provenge (sipuleucel-T)
|
Androgen-independent prostate
cancer
|
5/1/2010
|
|
InterMune
pirfenidone
|
Idiopathic
pulmonary fibrosis
|
5/4/2010
|
|
Bayer estradiol
valerate/dienogest
|
Oral
contraceptive with novel estrogen
component
|
5/8/2010 or
earlier
|
|
Nycomed/Forest
Daxas (roflumilast)
|
COPD
|
5/20/2010 or
earlier
|
|
June
|
|
Novartis
Gilenia (fingolimod)
|
Multiple
sclerosis
|
6/2010 if
priority request is granted
|
|
Shire
Replagal (agalsidase
alfa)
|
Fabry
disease
|
6/22/2010 or
earlier if priority
|
|
MedImmune
(AstraZeneca) motavizumab
|
Respiratory
syncytial virus prevention
|
6/23/2010
|
|
July
|
|
NicOx
naproxcinod
|
Osteoarthritis
|
7/24/2010
|
|
August
|
|
Lux Biosciences
Luveniq (voclosporin)
|
Noninfectious
uveitis
|
8/4/2010 or
earlier (priority review requested)
|
|
Valeant/GSK
retigabine
|
Partial onset
seizures
|
8/30/2010
|
|
September
|
|
AstraZeneca
Brilinta (ticagrelor)
|
Acute coronary
syndrome
|
9/19/2010 if
standard (5/19/2010 if priority)
|
|
Human Genome
Sciences/GSK Zalbin (albinterferon
alfa-2b)
|
Albumin-fusion
biosimilar of interferon for hepatitis
C
|
9/25/2010 or
earlier
|
|
Teva
Neutroval (filgrastim)
|
Biosimilar
version of filgrastim for chemotherapy-induced
neutropenia
|
9/30/2010
|
|
October
|
|
Forest
ceftaroline
|
Cephalosporin
antibiotic for cSSSI
|
10/2010
|
|
Jazz JZP-6
(sodium oxybate)
|
Fibromyalgia
|
10/15/2010 or
earlier
|
|
Protalix/Pfizer
Uplyso (taliglucerase
alfa)
|
Gaucher's
disease
|
10/9/2010 if
standard (6/9/2010 if priority)
|
|
Arena
lorcaserin
|
Obesity
|
10/22/2010 or
earlier
|
|
Vivus
Qnexa (phentermine/topiramate,
controlled release)
|
Obesity
|
10/29/2010 or
earlier
|
|
Dainippon
Sumitomo lurasidone
|
Schizophrenia
|
10/30/2010
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