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【drug-news】FDA批准酮替芬滴眼剂作为OTC药物上市
现在诺华将它开发成OTC滴眼剂将进一步扩大此药的应用，请看来自FDA新的消息
FDA Approves Prescription Zaditor(R) for Over-The-Counter Relief From Itchy Eyes
New OTC Zaditor. (PRNewsFoto/Novartis Ophthalmics)
FLORHAM PARK, NJ UNITED STATES 10/20/2006
* Zaditor Provides Up to 12 Hours of Continuous Itch Relief With One Drop
* Only Non-Prescription Medication to Relieve Eye Itch Without a
Decongestant
* First Over-The-Counter Eye Itch Relief Drop Safe for Children as Young as
Three
FLORHAM PARK, N.J., Oct. 20 /PRNewswire/ -- Novartis Pharmaceuticals
Corporation today announced that the U.S. Food and Drug Administration
(FDA) has approved prescription Zaditor(R) (ketotifen fumarate ophthalmic
solution 0.025%), indicated for the temporary prevention of itchy eyes due
to allergic conjunctivitis, for OTC use. An estimated 40 million Americans
suffer from eye allergies. Whether in reaction to seasonal allergens
including pollen and ragweed, or perennial allergens such as animal hair or
pet dander, itchy eyes are a main complaint.
(Photo: http://www.newscom.com/cgi-bin/prnh/20061020/NYF049 )
While most OTC products provide only 3-4 hours of short-term relief,
Zaditor's full prescription strength formula offers eye itch relief that
works in minutes and lasts up to 12 hours with just one drop. This
significantly reduces the number of doses required per day to keep affected
eyes itch-free. In addition, Zaditor is the first OTC eye itch medication
safe for use in children as young as three.
"Now for the first time, people who suffer from itchy eyes caused by
allergens such as pollen or pet dander can get fast, long-acting relief
over- the-counter with Zaditor," says Marion Morton, Head of the US
Novartis Ophthalmics Business Unit. "Because Zaditor is now available at
full prescription strength without a prescription, consumers can save time
and money without sacrificing long-lasting symptom relief."
Zaditor is the only OTC drop to treat eye itch associated with pollen,
ragweed, grass, animal hair and dander without the potentially negative
effects of a decongestant. Many OTC eye drops contain topical
decongestants, which constrict the blood vessels to reduce the appearance
of redness in the eye. With regular use, these products can interfere with
the eye's natural ability to regulate the blood vessels, resulting in a
continued redness for a period of time after discontinuation (rebound
effect). Zaditor does not contain a decongestant and may be used without
risk of rebound redness.
"The availability of Zaditor without a prescription greatly improves
treatment options for eye itch sufferers," said Jane MacEnroe, MD,
Associate Director, Medical Information and Communication, Novartis
Ophthalmics. "For the first time, patients can get lasting relief
over-the-counter without worrying about potential side-effects associated
with long-term use of topical decongestants found in other OTC eye itch
drops."
Triple Mechanism of Action
Zaditor is the only OTC eye itch drop with a triple-action formula to
provide fast, durable efficacy at the source. It includes a:
* Potent antihistamine that rapidly relieves itchy eyes within minutes
* Mast cell stabilizer that provides extended relief for up to 12 hours
* Prevents the release of chemical mediators to stop the late phase
allergic reaction
Histamines, a chemical made by the body during an allergic reaction,
are a primary cause of itchy eyes. Unlike most OTC drops, Zaditor blocks
the histamines that cause itchy eyes and prevents the release of additional
histamines, treating the source of the itch, not just the symptoms.
Approved in 1999 for prescription use, Zaditor has become a leading
treatment for the temporary prevention of itchy eyes due to allergic
conjunctivitis. Zaditor will be available over-the-counter in drug and
chain stores nationwide beginning January 2007. It has a suggested retail
price of $14.99 for a 30-day supply. In clinical studies, Zaditor was well
tolerated and any side effects are generally mild.
Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "will," or similar expressions, or by
express or implied discussions regarding potential future sales of Zaditor.
Such forward-looking statements involve known and unknown risks,
uncertainties and other factors that may cause actual results with Zaditor
to be materially different from any future results, performance or
achievements expressed or implied by such statements. Management's
expectations regarding Zaditor could be affected by, among other things,
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作者:admin@医学,生命科学 2010-11-04 05:11
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