March
Supplements
|
|
Chart lists
efficacy supplements and labeling supplements
selected by the editors of
"Pharmaceuticals Approvals Monthly."This is not a
comprehensive list of all supplemental
approvals.
|
|
Product
|
Sponsor
|
Change
|
Date
Approved
(Application No.)
|
|
Drug
|
|
Advair Diskus
Fluticasone propionate/salmeterol xinafoate
inhalation powder
|
GlaxoSmithKline
|
Revises
labeling to revise warnings/precautions section to
show the effect of Advair Diskus on bone mineral
density in subjects with chronic obstructive
pulmonary disease
|
3/31/2009
(21-077/036
|
|
Altace
Ramipril
|
King
|
Revises
warnings/precautions section of labeling regarding
use of ACE inhibitors during the first trimester of
pregnancy, based on recently published article
|
3/4/2009
(19-901/052)
(22-021/001)
|
|
Crestor
Rosuvastatin
|
AstraZeneca
|
Adds
hepatic failure to the postmarketing experience
subsection of the adverse reactions section of
labeling
|
3/27/2009
(21-366/015)
|
|
Dalmane
Flurazepam HCl
|
Valeant
|
Provides
for implementation of a Medication Guide
|
3/27/2009
(16-721/077)
|
|
Diabeta
Glyburide
|
Sanofi-Aventis
|
Revises
indication and precautions sections of labeling to
note that there have been no clinical studies
establishing conclusive evidence of macrovascular
risk reduction with Diabeta or any other
anti-diabetic drug; adds contraindication in patients
treated with bosentan; adds precaution on hemolytic
anemia; updates drug interactions
|
3/5/2009
(17-532/027
& 028)
|
|
Eloxatin
Oxaliplatin
|
Sanofi-Aventis
|
Updates
postmarketing adverse reactions to note that
interstitial lung disease cases have sometimes been
fatal and add transient vision loss
|
3/13/2009
(21-492/011)
|
|
Epzicom
Abacavir sulfate/lamivudine
|
GlaxoSmithKline
|
Revises
Medication Guide, black box warning,
contraindications and warnings to note the
association of the HLA-B*5701 allele with
abacavir-related hypersensitivity reactions and
recommend HLA-B*5701 testing prior to initiating
abacavir therapy
|
3/9/2009
(21-652/008)
|
|
Humatrope
Somatropin [rDNA origin]
|
Lilly
|
New
indication for treatment of short stature in
pediatric patients small for gestational age who do
not manifest catch-up growth by age 2 to 4
years
|
3/12/2009
(19-640/068)
|
|
Lexapro
Escitalopram
|
Forest
|
Provides
for use for acute and maintenance treatment of
adolescent major depressive disorder
|
3/19/2009
(21-323/030
& 031)
(21-365/021 & 022)
|
|
Lipitor
Atorvastatin
|
Pfizer
|
Adds
hepatic failure to the postmarketing experience
subsection of the adverse reactions section of
labeling
|
3/27/2009
(20-702/057)
|
|
Neggram
Nalidixic acid
|
Sanofi-Aventis
|
Updates
labeling on renal insufficiency
|
3/28/2009
(14-214/058)
|
|
Novothyrox
Levothyroxine
|
Merck
KGaA
|
Adds
statement to precaution in labeling that agents such
as iron and calcium supplements and antacids can
decrease the absorption of levothryroxine tablets, as
requested by FDA in June 2005; also adds drug
interaction with orlistat, as requested
|
3/26/2009
(21-292/002)
|
|
OsmoPrep
Sodium phosphate monobasic monohydrate, USP and
sodium phosphate dibasic anhydrous, USP
|
Salix
|
Revises
labeling regarding risk of acute phosphate
nephropathy, as requested by FDA in December 2008 and
agreed in a March 9 teleconference
|
3/25/2009
(21-892/003)
|
|
Prozac
Fluoxetine
|
Lilly
|
New
indications for use in combination with
Zyprexa for acute treatment of
depressive episodes associated with bipolar I
disorder and acute treatment of treatment-resistant
depression; also provides for a comprehensive
Medication Guide
|
3/19/2009
(18-936/075
& 077)
|
|
Reclast
Zoledronic acid
|
Novartis
|
New
indication for treatment and prevention of
glucocorticoid-induced osteoporosis in patients
expected to be on glucocorticoids for at least 12
months
|
3/13/2009
(21-817/003)
|
|
Stalevo
Levodopa/carbidopa/
entacapone
|
Orion
|
Adds
information to labeling regarding intense urges to
gamble, increased sexual urges and other intense
urges in patients using medications to treat
Parkinson's disease; adds precaution regarding
melanoma
|
3/3/2009
(21-485/008)
|
|
Symbyax
Olanzapine/fluoxetine
|
Lilly
|
New
indications for acute treatment of depressive
episodes associated with bipolar I disorder and acute
treatment of treatment-resistant depression
|
3/19/2009
(21-520/012)
|
|
Trizivir
Abacavir/lamivudine/
zidovudine
|
GlaxoSmithKline
|
Revises
Medication Guide, black box warning,
contraindications and warnings to note the
association of the HLA-B*5701 allele with
abacavir-related hypersensitivity reactions and
recommend HLA-B*5701 testing prior to initiating
abacavir therapy; adds information regarding
myocardial infarction to precautions section of
labeling and MedGuide
|
3/9/2009
(21-205/021)
|
|
Tygacil
Tigecycline
|
Wyeth
|
New
indication for community acquired pneumonia, addition
of pathogens to the complicated skin and skin
structure indication and for the complicated
intra-abdominal indication
|
3/20/2009
(21-821/013, 017 & 018)
|
|
Visicol
Sodium phosphate monobasic monohydrate, USP and
sodium phosphate dibasic anhydrous, USP
|
Salix
|
Revises
labeling regarding risk of acute phosphate
nephropathy, as requested by FDA in December 2008 and
agreed in a March 9 teleconference
|
3/25/2009
(21-097/013)
|
|
Biological
|
|
PegIntron
Peginterferon alfa-2b
|
Schering-Plough
|
Expands
indication to include retreatment of chronic
hepatitis C patients who failed to respond or
relapsed after treatment with combination alpha
interferon/ribavirin therapy
|
3/10/2009
(103949/5125)
|
|
Raptiva
Efalizumab
|
Genentech
|
Adds safety
information regarding progressive multifocal
leukoencephalopathy to labeling and Medication Guide
[Editor's note: Firm announced April 8 that
product will be withdrawn from the market due to risk
of PML]
|
3/13/2009
(125075/130)
|
