September Supplements
|
|
Chart lists
efficacy supplements and labeling supplements
selected by the editors of "Pharmaceutical
Approvals Monthly."This is not a comprehensive
list of all supplemental approvals.
|
|
Product
|
Sponsor
|
Change
|
Date Approved
(Application No.)
|
|
Drug
|
|
Aceon
Perindopril
|
Solvay
|
Updates pregnancy information in
labeling on effects of ACE inhibitors during
pregnancy
|
9/3/2008
20/0184/013 & 014)
|
|
Alimta
Pemetrexed
|
Lilly
|
New indication for treatment of
locally advanced or metatstatic non-squamous
non-small cell lung cancer in combination with
cisplatin as intitial therapy or as a single agent
after prior chemotherapy
|
9/26/2008
(21-462/015)
|
|
Celexa
Citalopram
|
Forest
|
Provides for class labeling, adding
precaution that SSRIs and SNRIs may increase the risk
of bleeding events, especially when used with
aspirin, NSAIDs, warfarin and other anticoagulants;
and also precaution that hyponatremia may occur as a
result of treatment with SSRIs and SNRIs
|
9/17/2008
(20-822/035 & 014)
|
|
Exubera
Insulin human [rDNA origin] inhalation powder
|
Pfizer
|
Adds information regarding lung cancer
to the warnings section of labeling
|
9/29/2008
(21-868/016 & 017)
|
|
Gleevec
Imatinib mesylate
|
Novartis
|
Adds information to labeling about
renal insufficiency, increased hepatotoxicity and
hypothyroidism
|
9/26/2007
(21-588/021 & 022)
|
|
Lariam
Mefloquine
|
Hoffman-La Roche
|
Updates safety information in
labeling, including addition of reports of dizziness
or vertigo and loss of balance that continue for
months after discontinuation of the drug in a small
number of patients
|
9/23/2008
(19-591/024 & 025)
|
|
Lexapro
Escitalopram
|
Forest
|
Provides for class labeling, adding
precaution that SSRIs and SNRIs may increase the risk
of bleeding events, especially when used with
aspirin, NSAIDs, warfarin and other anticoagulants;
and also precaution that hyponatremia may occur as a
result of treatment with SSRIs and SNRIs
|
9/17/2008
(21-365/018 & 019
(21-864/028 & 029)
|
|
Nasacort AQ
Triamcinolone acetonide
|
Sanofi-Aventis
|
Provides for use for seasonal and
perennial allergic rhinitis in patients two to five
years of age
|
9/19/2008
(20-468/024)
|
|
Noroxin
Norfloxacin
|
Merck
|
Revises labeling to ensure consistency
in communication of the risks of acute liver failure
and acute severe liver injury, QTc
prolongation/torsades de pointes, tendon rupture,
toxic epidermal necrolysis and phototoxicity as
requested by FDA
|
9/23/2008
(19-384/049 & 050)
|
|
Photofrin
Porfimer sodium
|
Axcan Pharma US
|
Updates labeling to include five year
data from study PHO BAR 02 for the ablation of
high-grade dysplasia in Barrett's esophagus
|
9/18/2008
(20-451/019)
|
|
Proair HFA
Albuterol sulfate
|
Teva
|
New indication for treatment or
prevention of bronchospasm with reversible
obstructive airway disease and for prevention of
exercise-induced bronchospasm in patients four
through 11 years
|
9/16/2008
(21-457/013)
|
|
Retrovir
Zidovudine
|
GlaxoSmithKline
|
Provides for twice-daily dosing in
pediatric patients six weeks to under 18 years of
age
|
9/19/2008
(19-910/033)
(19-655/046)
(20-518/016)
|
|
Reyataz
Atazanavir
|
Bristol-Myers Squibb
|
Provides for co-administration with
ritonavir
|
9/30/2008
(21-567/017)
|
|
Stromectol
Ivermectin
|
Merck
|
Revises precautions to note need for
repeated stool examination to document clearance of
infection with Strongyloides stercoralis and also
that treatment does not kill the adult Onchocerca
parasites and therefore repeated follow-up and
retreatment is usually required
|
9/12/2008
(50-742/022)
|
|
Tamiflu
Oseltamivir
|
Hoffman-La Roche
|
Labeling updated with statement
regarding resistance mutations in indications and
usage section
|
9/25/2008
(21-087/047)
|
|
Tarceva
Erlotinib
|
OSI
|
Provides for changes to the clinical
pharmacology, warnings, precautions, adverse
reactions, and dosage and administration sections of
labeling and changes labeling to comply with the
physicians labeling rule
|
9/12/2008
(21-743/008, 010 & 011)
|
|
Valtrex
Valacyclovir
|
GlaxoSmithKline
|
New indication for treatment of
chickenpox in children two to up to 18 years of
age
|
9/3/2008
(20-487/014)
|
|
Ventavis
Iloprost
|
Actelion
|
Revises labeling to caution that
Ventavis inhalation can induce bronchospasm,
especially in patients with hyperreactive airways,
and notes that it has not been evaluated in patients
with COPD, severe asthma or with acute pulmonary
infections; updates other adverse reactions
|
9/22/2008
(21-779/008)
|
|
Videx EC
Didanosine
|
Bristol-Myers Squibb
|
Provides for use in pediatric patients
who weigh greater than 20 kg; updates clinical
pharmacology section of labeling on hepatic
impairment
|
9/29/2008
(21-183/020)
|
|
Biologics
|
|
Erbitux
Cetuximab
|
ImClone
|
Revises warnings and precautions
sections of labeling on infusion reactions and
dermatology toxicity
|
9/13/2008
(125084/139)
|
|
Rituxan
Rituximab
|
Genentech
|
Revises warning/precaution on
progressive multifocal leukoencephalopathy to include
information on PML occurring in rituximab-treated
patients with rheumatoid arthritis; adds information
regarding B-cell lymphocytopenia in infants exposed
to rituximab in utero
|
9/8/2008
(103705/5291 & 5285)
|
