September Supplements
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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.
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Drug
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Product
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Sponsor
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Change
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Date
Approved
(Application No.)
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Actiq
Fentanyl citrate, oral transmucosal lozenge
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Cephalon
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Sugar-free
formulation
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9/9/2005
(20-747/019)
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Actonel
Risedronate sodium, tab.
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Procter
& Gamble
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Adds
precautions regarding severe musculoskeletal pain and
osteonecrosis of the jaw, adds severe musculoskeletal
pain to adverse reactions
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9/12/2005
(20-835/020)
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Amaryl
Glimepiride, tab.
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Sanofi-Aventis
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Revises
adverse reactions labeling to reflect post-marketing
reports of dermatologic, hematologic and metabolic
reactions
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9/19/2005
(20-496/016)
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Angiomax
Bivalirudin, inj.
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The
Medicines Company
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Updates
adverse reactions to include events reported during
post-marketing surveillance, revises dosage &
administration labeling to advise of potential
incompatibility with dobutamine
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9/2/2005
(20-873/014)
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Argatroban,
inj.
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Encysive
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Adds
incidence of intracranial bleeding in ischemic stroke
patients to adverse reactions and dosage &
administration labeling
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9/1/2005
(20-883/009)
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Arimidex
Anastrozole, tab.
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AstraZeneca
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Updates
ATAC study data to satisfy subpart H accelerated
approval commitment
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9/16/2005
(20-541/016)
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Cordarone
Amiodarone, I.V.
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Wyeth
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Adds acute
renal failure, renal impairment, renal insufficiency
and agranulocytosis to adverse reactions section of
labeling; clarifies labeling text
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9/15/2005
(20-377/018)
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Coumadin
Warfarin sodium, tab. & inj.
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Bristol-Myers Squibb
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Includes
information relating to interactions with proton pump
inhibitors and language cautioning against ingestion
of cranberry products, which have been reported to
affect patient response
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9/2/2005
(09-218/101)
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Diastat AcuDial
Diazepam rectal gel
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Valeant
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Provides
for a second generation rectal drug delivery system
consisting of pre-filled unit-dose syringes that can
deliver varying quantities
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9/15/2005
(20-648/008)
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Flovent Diskus
Fluticasone propionate, inhalation powder
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GlaxoSmithKline
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Adds
anxiety, behavioral changes including hyperactivity
and irritability to adverse reactions section
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9/14/2005
(20-833/015)
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Fortovase
Saquinavir, soft-gel capsule
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Roche
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Adds
information on interaction with rifampin, and between
saquinavir/ritonavir and tenofovir, fosamprenavir,
lopinavir and atazanavir
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9/8/2005
(20-828/019)
(20-828/020)
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Invirase
Saquinavir mesylate, capsule & tab.
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Roche
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Adds
information on interaction with rifampin, and between
saquinavir/ritonavir and tenofovir, fosamprenavir,
lopinavir and atazanavir
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9/8/2005
(20-628/022
& 023) (21-785/001 & 002)
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Lipitor
Atorvastatin, tab.
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Pfizer
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New claims
based on the Collaborative Atorvastatin Diabetes
Study for use in adult patients with type 2 diabetes
and without clinically evident coronary heart disease
(but with multiple risk factors for coronary heart
disease such as retinopathy, albuminuria, smoking, or
hypertension) to reduce the risk of myocardial
infarction and stroke; also to reduce the risk of
stroke in adult patients without clinically evident
coronary heart disease but with multiple risk factors
for coronary heart disease such as age, smoking,
hypertension, low HDL-C, or a family history of early
coronary heart disease
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9/21/2005
(20-702/042)
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Lupron
Leuprolide acetate, inj.
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TAP
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Revises
labeling to include information on pituitary
apoplexy
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9/15/2005
(20-011/031)
(19-943/024)
(20-517/019)
(19-732/029)
(20-708/021)
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Micardis HCT
Telmisartan, tab.
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Boehringer
Ingelheim
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Adds
post-marketing experience subsection to adverse
events section
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9/2/2005
(21-162/008)
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Niaspan
Niacin, extended-release tab.
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Kos
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New 1,000
mg formulation
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9/9/2005
(20-381/023)
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Norvasc
Amlodipine besylate, tab.
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Pfizer
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Revises
labeling with regard to use in patients with
angiographically documented coronary artery
disease
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9/28/2005
(19-787/038)
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NovoLog
Insulin aspart [rDNA origin], inj.
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Novo
Nordisk
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Adds use in
pediatric patients aged 6 to 18 years based on a
283-patient study, discussed in the precautions
section of labeling, that found similar rates of
glycemic control and hypoglycemia for NovoLog and
regular human insulin in pediatric patients
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9/13/2005
(20-986/033)
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Sandostatin
Octreotide acetate, inj.
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Novartis
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Adds
precaution regarding effect on glucose regulation in
diabetics, interaction with bromocriptine and other
drugs metabolized by CYP3A4 which have a low
therapeutic index; adds geriatric use subsection to
precautions urging cautious dose selection in elderly
patients; and adds rare instances of gastrointestinal
side effects resembling acute intestinal obstruction
to the adverse reactions section of labeling
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9/2/2005
(19-667/050)
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SecreMax
Synthetic porcine secretin, inj.
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ChiRhoClin
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Replaces
SecreMax tradename with SecreFlo and
replaces ChiRhoClin logo with Repligen logo
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9/12/2005
(21-136/011)
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Viadur
Leuprolide acetate, implant
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Alza
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Adds
post-marketing reports of rare cases of pituitary
apoplexy after administration of
gonadotropin-releasing hormone agonists
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9/15/2005
(21-088/022)
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Viracept
Nelfinavir, oral powder and tab.
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Agouron
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Updates
drug interactions and adds to the precautions section
reports of immune reconstitution syndrome in patients
receiving combination antiretroviral therapy
including Viracept
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9/28/2005
(20-778/024)
(20-779/045)
(21-503/006)
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Xenical
Orlistat, capsule
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Roche
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Updates
adverse reactions seen in post-marketing
surveillance
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9/2/2005
(20-766/021)
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Zemplar
Paricalcitol, inj.
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Abbott
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Revises
indication wording, replacing "chronic renal failure"
with "chronic kidney disease Stage 5" and removing
discussion of studies; also revises description,
clinical pharmacology, warnings, precautions, adverse
reactions, dosage & administration, and how
supplied sections of labeling; combines the
previously separate package inserts for the 2 mcg/mL
and 5 mcg/mL strengths into single package
insert
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9/2/2005
(20-819/015)
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Zosyn
Piperacillin/tazobactam, inj.
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Wyeth
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Provides
for reformulation of the product and labeling
revisions, including discussion of which
aminoglycosides the reformulated Zosyn with EDTA is
compatible with for co-administration via
Y-site
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9/30/2005
(50-684/045)
(50-750/012)
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Zyprexa
Olanzapine, tab., orally disintegrating tab. and
intramuscular inj.
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Lilly
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Revises
indication for combination therapy of bipolar
disorder to read "acute mixed or manic" states
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9/13/2005
(20-592/034)
(21-086/015)
(21-253/015)
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Biologicals
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Product
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Sponsor
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Change
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Date
Approved
(Application No.)
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Avastin
Bevacizumab
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Genentech
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Adds
results of NCI's Treatment Referral Center study of
bevacizumab, infusional 5-fluorouracil and leucovorin
to clinical studies section of the package
insert
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9/29/2005
(12-5085/45)
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Erbitux
Cetuximab
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ImClone
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Revises
warnings, dosage & administration sections of
labeling to recommend one-hour observation period
following infusion and longer observation period for
patients who experience infusion reactions
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9/1/2005
(12-5084/30)
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Remicade
Infliximab
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Centocor
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New
indication for patients with moderately to severely
active ulcerative colitis who have had an inadequate
response to conventional therapy
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9/15/2005
(10-3772/5113)
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Zevalin
Ibritumomab tiuxetan
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Biogen
Idec
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Adds
information on mucocutaneous and cutaneous reactions
to the boxed warnings, warnings and adverse reactions
sections of labeling
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9/13/2005
(12-5019/92)
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