|
Future
Highlights?
Novel Products With User Fee Goals In The Second Half
Of 2009
|
Sponsor
& Drug
|
Indication
|
User Fee
Date
|
|
July
|
|
Bristol-Myers Squibb/AstraZeneca
Onglyza (saxagliptin)
|
DPP-4
inhibitor anti-diabetic
|
7/30/2009
|
|
Xanodyne
XP12B (tranexamic acid)
|
Menorrhagia
|
7/30/2009
|
|
Advanced
Life Sciences' Restanza
(cethromycin)
|
Ketolide
antibiotic
|
7/31/2009
|
|
Duramed/DoD
adenovirus vaccine (types 4 and 7)
|
Respiratory
virus vaccine
|
7/31/2009
|
|
August
|
|
Johnson
& Johnson Invega Sustenna
(paliperidone palmitate)
|
Antipsychotic in once-monthly injection
formulation
|
8/2009
|
|
Schering-Plough Saphris
(asenapine)
|
Antipsychotic
|
8/2009
|
|
Kowa
Livalo (pitavastatin)
|
Dyslipidemia
|
8/1/2009
|
|
Savient
Krystexxa (pegloticase)
|
Gout
|
8/1/2009
|
|
Johnson
& Johnson Comfyde
(carisbamate)
|
Epilepsy
|
8/24/2009
or earlier
|
|
Auxilium
Xiaflex (collagenase clostridium
histolyticum)
|
Depuytren's
contracture
|
8/28/2009
(FDA is expected to miss goal as advisory committee
will not meet until 9/16/2009)
|
|
September
|
|
Ista
Bepreve (bepotastine)
|
Ocular
itching from allergic conjunctivitis
|
9/12/2009
|
|
Theravance/Astellas telavancin
|
Lipoglycopeptide antibiotic
|
9/16/2009
|
|
Johnson
& Johnson/PharmaMar Yondelis
(trabectedin)
|
Ovarian
cancer
|
9/20/2009
or earlier*
|
|
Allos
pralatrexate
|
Peripheral
T-cell lymphoma
|
9/24/2009
|
|
GSK
Cervarix (vaccine, HPV types 16 and
18)
|
Human
Papillomavirus Vaccine
|
9/30/2009
|
|
October
|
|
GSK
Armala (pazopanib)
|
Renal cell
carcinoma
|
10/2009*
|
|
Novartis
indacaterol
|
COPD
|
10/2009*
|
|
Johnson
& Johnson Stelara
(ustekinumab)
|
Psoriasis
|
10/2009
|
|
Wyeth
Prevnar 13 (vaccine, pneumococcal 13
variant conjugate)
|
Pneumococcal disease vaccine
|
10/1/2009
|
|
King
CorVue (binodenoson)
|
Pharmacologic stress test imaging
agent
|
10/18/2009
or earlier
|
|
Amgen
Prolia (denosumab)
|
Osteoporosis; Hormone ablation-induced bone
loss
|
10/19/2009
|
|
Acorda
fampridine-SR
|
Multiple
sclerosis (walking ability)
|
10/22/2009
|
|
GlaxoSmithKline/Gemnab Arzerra
(ofatumumab)
|
Chronic
lymphocytic leukemia
|
10/31/2009
|
|
Sanofi-Aventis Ciltyri
(eplivanserin)
|
Insomnia
|
4th quarter 2009
|
|
November
|
|
Orphan
Therapeutics/Ikaria Lucassin
(terlipressin)
|
Hepatorenal
syndrome type 1
|
11/4/2009
|
|
GSK/Xenoport Solzira
(gabapentin enacarbil)
|
Restless
leg syndrome
|
11/9/2009
or earlier
|
|
Human
Genome Sciences ABthrax
(raxibacumab)
|
Anthrax
|
11/21/2009
or earlier
|
|
Theratechnologies/EMD Serono
tesamorelin
|
HIV-associated lipodystrophy
|
11/29/2009
|
|
December
|
|
Dyax
Kalbitor (ecallantide)
|
Acute
attacks of hereditary angioedema
|
12/1/2009
|
|
Vion
Onrigin (laromustine)
|
Acute
myeloid leukemia in poor-risk elderly patients
|
12/12/2009
|
|
Cell
Therapeutics pixantrone
|
Non-Hodgkin's lymphoma
|
12/24/2009
|
