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The Sponge Is Back
After more than a decade with no contraceptive sponge on the market,
Allendale Pharmaceuticals, Inc, has recently received US Food and
Drug Administration (FDA) reapproval to market the over-the-counter,
hormone-free contraceptive sponge (The Today Sponge). The soft
polyurethane foam sponge provides 24 hours of contraceptive protection
by blocking the passage of sperm into the cervix, continually releasing
nonoxynol-9 spermicide, and absorbing semen so that sperm do not
enter the cervix. The sponge can be inserted up to 24 hours prior
to intercourse. The sponge does not need to be changed with every
act of intercourse but must remain in place for 6 hours after sexual
intercourse and should not remain in the vagina for more than 30
consecutive hours. When used as indicated with every act of intercourse
the sponge is 89% to 91% effective against pregnancy.
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Heart Health
The FDA has granted approval to Ranbaxy Pharmaceuticals Inc for the manufacture
and marketing of generic antihyperlipidemic pravastatin sodium tablets
(Pravastatin) for the primary and secondary prevention of coronary heart
disease. Available in four doses, 10 mg, 20 mg, 40 mg, and 80 mg, the
pravastatin sodium tablets are intended to reduce the risk of myocardial
infarction, lessen patient need for myocardial revascularization, and
prevent cardiovascular mortality. Indications for secondary prevention
include reducing the risk of stroke and transient ischemic stroke, and
inhibiting the development of coronary atherosclerosis.
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Breathing Easy
Already approved for the treatment of asthma and seasonal allergy
symptoms, Merck and Co, Inc’s, montelukast sodium (Singulair) oral
tablets received FDA approval for the new indication of preventing exercise-induced
bronchoconstriction for patients aged 15 years and older. The basis of the
approval comes from the results of three randomized, double-blind, placebo-controlled
clinical trials in which patients who were administered a single dose of
montelukast sodium, 10 mg, 2 hours before exercise experienced less exercise-induced
asthma symptoms versus patients receiving placebo.
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New Hope for
Bleeding Disorder
ZLB Behring has received
FDA approval for their factor
VIII/von Willebrand factor (vWF) protein complex (human) dried, pasteurized
(Humate-P) for the prevention of excessive spontaneous or trauma-induced bleeding
in von Willebrand disease-positive patients. The intravenous biologic therapy
replaces the missing factor VIII/vWF proteins in patients who suffer from
von Willebrand disease to improve clotting. Results from two separate clinical
trials involving 62 patients showed that the biologic therapy helped reduce
excessive blood loss in both severe cases of von Willebrand disease and in
less severe cases when other therapies were inadequate.
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Protecting Against the
Bird Flu
In an effort to prevent a possible global epidemic, the FDA has approved
the first vaccine to protect humans against the influenza type A H5N1 avian
virus in the United States. Manufactured by Sanofi Pasteur, the vaccine
is not available commercially but has been purchased by the US Centers for
Disease Control and Prevention for the strategic national stockpile to be
distributed by public health officials if necessary. The vaccine is intended
for the immunization of people aged 18 to 64 years. A clinical study analyzing
important safety information and appropriate dosage levels in 103 healthy
adults showed that patients receiving the 0.09-mg vaccination in two doses
administered 28 days apart produced enough antibodies to effectively reduce
the risk of viral infection.
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Preventing Blood Clots
Eisai Inc’s dalteparin sodium injection (Fragmin) has received FDA approval
for the expanded indication for the treatment of symptomatic venous thromboembolism
(VTE) in cancer patients. Approval for the low-molecular-weight heparin injection
was based on data from a randomized, double-arm study involving 338 cancer
patients. Results revealed that patients receiving the dalteparin sodium injection
for the whole duration of the study had a lower recurrence rate of VTE than
those patients who received the injection for only 5 to 7 days during treatment
and were then administered a standard anticoagulant treatment.
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Parkinson
Prevention Patch
Recently, the FDA approved Schwarz Pharma’s rotigotine transdermal system
(Neupro) for the treatment of early signs and symptoms of Parkinson disease.
The nonergolinic dopamine receptor agonist mimics naturally occurring dopamine
in the brain to stimulate neurological motor functioning. The first transdermal
system FDA-approved for the treatment of Parkinson disease, this once daily
patch provides 24 hours of continuous rotigotine exposure.
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Sleeping Easier
The FDA has granted permission to 13 companies to manufacture the
first generic versions of zolpidem tartrate (Ambien) 5-mg and 10-mg oral
tablets indicated for the treatment of short-term insomnia. The nonbenzodiazepine
hypnotic, belonging to the imidazopyridine class of drugs, is a part of
the FDA’s continuous effort to provide low-cost alternatives to brand
name drugs via generic drug competition.
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