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5/26/2017
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`FDA OKs Generic Version of Flonase
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`FDA OKs Generic
`Version of
`Flonase
`
`Generic Version Is Called Fluticasone
`Propionate Nasal Spray
`
`By Miranda Hitti
`
`  
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`
`
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`FROM THE WEBMD ARCHIVES
`
`
`Feb. 22, 2006 -- The FDA has approved the
`first generic version of the brand-name
`drug Flonase, a nasal spray that treats
`allergic and nonallergic nasal symptoms.
`
`The generic product is called fluticasone
`propionate nasal spray. It's approved for
`use in adults and children who are at
`least 4 years old.
`
`The generic spray contains a synthetic,
`inflammation-fighting corticosteroid.
`Fluticasone propionate, like other
`corticosteroids, doesn't have an
`immediate eect on allergic symptoms.
`
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`A decrease in nasal symptoms (stuiness,
`runniness, itching, and sneezing) has
`FDA OKs Generic Version of...
`been noted in some patients 12 hours
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`CIP2130
`Argentum Pharmaceuticals LLC v. Cipla Ltd.
`IPR2017-00807
`
`

`

`5/26/2017
`
`ADVERTISEMENT
`
`FDA OKs Generic Version of Flonase
`aer initial treatment. Common side
`eects of fluticasone propionate nasal
`spray are headache, sore throat, and
`nose bleed.
`
`FDA's Comments
`"Except for their price, which is much
`lower, generic drugs are in every way
`equivalent to their brand-name
`counterparts," says Steven Galson, MD,
`MPH, in an FDA news release. Galson
`directs the FDA's Center for Drug
`Evaluation and Research.
`
`"Oering consumers a choice of safe,
`eective, and reasonably priced generic
`drug products is an extremely important
`priority for [the] FDA. Today's approval is
`part of our ongoing commitment to
`provide generic forms of products to the
`public," Galson continues.
`
`Generic drug products are used to fill
`over 50% of all prescriptions and cost a
`fraction of the price of brand-name drugs.
`In 2005, the FDA approved 452 generic
`drug applications, the second highest
`total on record.
`
`Brand-Name Patent Expired
`
`The brand-name version of the spray,
`Flonase, is manufactured by
`GlaxoSmithKline. The patent for Flonase
`expired in May 2004. GSK is a WebMD
`sponsor.
`
`The FDA received several petitions from
`citizens questioning the approval criteria
`for the generic spray, according to an FDA
`news release. Aer reviewing those
`petitions, the FDA stands behind its
`FDA OKs Generic Version of...
`decision.
`
`SUBSCRIBE
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`
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`FDA OKs Generic Version of Flonase
`"The FDA submits generic drug
`applications to the same thorough and
`rigorously scientific review for safety,
`eectiveness, and quality as the
`applications for new drugs," the release
`states.
`
`"Consumers and health professionals can
`be assured that an approved generic drug
`is bioequivalent to a brand-name drug
`and is its equal in dosage form, strength,
`route of administration, quality,
`performance characteristics, and
`intended use," the release continues.
`
`The nasal spray's generic version is made
`by Roxane Laboratories of Columbus,
`Ohio.
`
`ARTICLE
`What Are Hives?
`
`ARTICLE
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`Doctor
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`TOOLS & RESOURCES
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`Allergies vs. Colds
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`Seasonal Allergy Relief 101
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`Check Your Sinus Symptoms
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`Do You Have Chronic Hives?
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`WebMD Health News | Reviewed by Louise Chang, MD on
`February 22, 2006
`
`Treating Hives at Home
`
`Sources
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`© 2006 WebMD, Inc. All rights reserved.
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`FDA OKs Generic Version of...
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`5/26/2017
`
`FDA OKs Generic Version of Flonase
`
`Seasonal
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`Quiz: How
`Can You Find
`Relief?
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`How to Treat
`Your Flu
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`Are You
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`Video: 5
`Things to
`Know About
`FDA OKs Generic Version of...
`Neti Pots
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`FDA OKs Generic Version of Flonase
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