|
Product
|
Sponsor
|
Change
|
Date
Approved
(Application No.)
|
|
Actos
Pioglitazone 15, 30 and 45 mg, tab.
|
Takeda
Pharmaceuticals North America
|
Addition of
cardiac failure warning and further information on
adverse events during combination use with
insulin
|
1/7/2002
(21-073/016)
|
|
Caverject
Alprostadil, sterile powder
|
Pharmacia
|
Revisions
to labeling and patient instructions to make them
consistent with aqueous Caverject injection and to
add a new clinical studies section
|
1/15/2002
(20-379/011)
|
|
Clozaril
Clozapine 25 and 100 mg, tab.
|
Novartis
|
Boxed
warning on myocarditis relocated to the beginning of
labeling and myocarditis data and treatment
guidelines added to warnings section
|
1/14/2002
(19-758/045)
|
|
Cutivate
Fluticasone propionate 0.005%,
ointment
|
GlaxoSmithKline
|
Revised
labeling regarding safety concerns with pediatric
use
|
1/18/2002
(19-957/011)
|
|
Depacon
Valproate sodium, inj.
|
Abbott
|
New safety
data on increased rate of infusion for the
antiepileptic
|
1/24/2002
(20-593/006)
|
|
Diovan HCT
Valsartan/hydrochlorothiazide 160/12.5 mg, tab.
|
Novartis
|
New
strength tablet
|
1/17/2002
(20-818/012)
|
|
Dipentum
Olsalazine sodium, capsule
|
Pharmacia
|
Addition of
geriatric use subsection under precautions section of
labeling
|
1/18/2002
(19-715/018)
|
|
Glofil-125
Sodium iothalamate I-125, inj.
|
Questcor
|
New
contraindication stating that the renal function
diagnostic agent should not be administered via
central venous line
|
1/22/2002
(17-279/008)
|
|
Infant's Motrin
Ibuprofen 50mg/1.25 mL, oral
suspension
(OTC)
|
McNeil
Consumer and Speciality Pharmaceuticals
|
New 1 oz.
package size and labeling revisions
|
1/16/2002
(20-603/005)
|
|
Kaletra
Lopinavir and ritonavir, capsule and oral
solution
|
Abbott
|
Full
approval of the HIV agent for use with other
antiretrovirals
|
1/18/2002
(21-226/003, 21-251/004)
|
|
Lidocaine
HCl in 5% dextrose, inj. in Viaflex
plastic container
|
Baxter
Healthcare
|
Addition of
geriatric use section
|
1/23/2002
(18-461/050)
|
|
Pitocin
Oxytocin, inj.
|
Parkdale
|
Geriatric
use subsection of labeling omitted
|
1/10/2002
(18-261/021)
|
|
Prandin
Repaglinide 0.5, 1 and 2 mg, tab.
|
Novo
Nordisk
|
Revisions
to labeling recommending 0.5 mg starting dose for
patients with severe renal function, deleting warning
of increased risk of cardiovascular mortality and
listing new drug-drug interactions
|
1/18/2002
(20-741/012)
|
|
Ritalin
Methylphenidate, tab.
|
Novartis
|
Labeling
adds contraindication for use with monoamine oxidase
inhibitors and a warning about concomitant use with
clonidine
|
1/11/2002
(10-187/060)
|
|
Ritalin-SR
Methylphenidate, sustained-release tab.
|
Novartis
|
Labeling
adds contraindication for use with monoamine oxidase
inhibitors and a warning about concomitant use with
clonidine
|
1/11/2002
(18-029/032)
|
|
Trelstar Depot
Triptorelin pamoate, injectable suspension
|
Pharmacia
|
New storage
procedures and new directions on use with the
Debioclip system
|
1/15/2002
(20-715/003) (20-715/004)
|
|
Xopenex
Levalbuterol HCl, inhalation solution
|
Sepracor
|
Pediatric
indication for treatment or prevention of
bronchospasm in children six to 11 years of age with
reversible obstructive airway disease, and a new 0.31
mg strength
|
1/30/2002
(20-837/006)
|
|
Biological
|
|
Product
|
Sponsor
|
Change
|
Date
Approved
(Application No.)
|
|
Betaseron
Interferon beta-1b, inj.
|
Berlex/Chiron
|
Room-temperature formulation of the
relapsing-remitting MS therapy
|
1/15/2002
|
|
Biothrax
Anthrax vaccine adsorbed
|
Bioport
|
Labeling
update
|
1/31/2002
(BL
103821/5015)
|
|
Biothrax
Anthrax vaccine adsorbed
|
Bioport
|
Approval of
Hollister-Stier Labs as the contract
manufacturer
|
1/31/2002
(BL
103821/5020)
|
|
Enbrel
Etanercept, inj.
|
Immunex
|
New
indication for reducing signs and symptoms of active
arthritis in patients with psoriatic arthritis; can
be used alone, or in combination with methotrexate in
patients who do not respond adequately to
methotrexate alone
|
1/15/2002
(BL
103795/5034)
|
