Trademark Trial and Appeal Board Electronic Filing System. http://estta.uspto.gov
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`ESTTA Tracking number:
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`ESTTA914863
`
`Filing date:
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`08/09/2018
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`
`Proceeding
`
`91226322
`
`Party
`
`Correspondence
`Address
`
`Plaintiff
`Lupin Pharmaceuticals, Inc.
`
`SUZANNA M M MORALES
`POWLEY & GIBSON PC
`304 HUDSON ST SUITE 202
`NEW YORK, NY 10013
`UNITED STATES
`Email: thcurtin@powleygibson.com, smmorales@powleygibson.com
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`Submission
`
`Filer's Name
`
`Filer's email
`
`Signature
`
`Date
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`Attachments
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`Testimony For Plaintiff
`
`Suzanna M. M. Morales
`
`trademarks@powleygibson.com, thcurtin@powleygibson.com, smmor-
`ales@powleygibson.com
`
`/suzanna m m morales/
`
`08/09/2018
`
`Lupin - Ampel - opposers notice of filing of SJ affidavits public 080818.pdf(10583
`bytes )
`public Berthold affidavit.pdf(1075130 bytes )
`public Liska part 1.pdf(4023075 bytes )
`public Liska part 2.1.pdf(2880318 bytes )
`public Liska part 2.2.pdf(2451226 bytes )
`
`

`

`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`
`
`In the matter of Application Serial No. 86509184
`For the Mark: LUPPIN
`Published in the Official Gazette on August 18, 2015
`-----------------------------------------------------x
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`LUPIN PHARMACEUTICALS, INC.,
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`Opposer,
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`-against-
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`AMPEL, LLC,
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`Applicant.
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`-----------------------------------------------------x
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`Opposition No. 91226322
`
`
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`OPPOSER’S NOTICE OF FILING OF
`AFFIDAVIT TESTIMONY PURSUANT TO STIPULATION
`
`PLEASE TAKE NOTICE, that, pursuant to the Joint Stipulation of the parties dated
`
`
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`August 7, 2018 (Document No. 26), Opposer files herewith the Affidavit of Dave Berthold in
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`Support of Motion for Summary Judgment by Opposer Lupin Pharmaceuticals, Inc. and the
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`Affidavit of Jay Liska in Support of Motion for Summary Judgment by Opposer Lupin
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`Pharmaceuticals, Inc., together with exhibits identified therein, which the parties have agreed
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`will be admissible as stated in the Joint Stipulation.
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`
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`Opposer has designated certain portions of the above-referenced affidavits and exhibits as
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`confidential pursuant to the Board’s Standard Protective Order and submits herewith redacted
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`versions. Opposer also submits separately, under seal, unredacted affidavits and exhibits.
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`

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`Dated: August 9, 2018
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`/suzanna m m morales/
`Thomas H. Curtin
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`
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`Robert L. Powley
`Thomas H. Curtin
`Diane B. Melnick
`Suzanna M. M. Morales
`POWLEY & GIBSON, P.C.
`304 Hudson Street, Suite 305
`New York, NY 10013
`Telephone: (212) 226-5054
`Facsimile: (212) 226-5085
`
`
`
`Attorneys for Opposer
`LUPIN PHARMACEUTICALS, INC.
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`By:
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`2
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`
`
`In the matter of Application Serial No. 86509184
`For the Mark: LUPPIN
`Published in the Official Gazette on August 18, 2015
`-----------------------------------------------------x
`
`
`
`
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`
`:
`LUPIN PHARMACEUTICALS, INC.,
`:
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`:
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`Opposer,
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`:
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`-against-
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`AMPEL, LLC,
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`Applicant.
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`-----------------------------------------------------x
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`
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`Opposition No. 91226322
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`
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`CERTIFICATE OF SERVICE
`
`
` I
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` hereby certify that on this 9th day of August, 2018, a true and correct copy of the foregoing
`Opposer’s Notice of Filing of Affidavit Testimony Pursuant to Stipulation was served on
`counsel of record for the Applicant via email, to:
`
`
`Patrick Asplin
`pca@lplaw.com
`Lenhart Pettit
`P.O. Box 2057
`Charlottesville, VA 22902
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`/suzanna m m morales/
`An Attorney for Opposer
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`3
`
`

`

`IN THE US. PATENT AND TRADEMARK OFFICE BEFORE THE
`TRADEMARK TRIAL AND APPEAL BOARD
`
`Efifiifi'ifiiiiii'iéffifiiiéfi's:i135;"""x
`
`Opposer,
`
`Opposition No. 91226322
`
`v.
`
`AMPEL, LLC,
`
`Applicant.
`______________________________________________________x
`
`AFFIDAVIT OF DAVE BERTHOLD IN SUPPORT OF MOTION FOR SUMMARY
`JUDGMENT BY OPPOSER LUPIN PHARMACEUTICALS, INC.
`
`ss.:
`
`) )
`
`)
`
`STATE OF MARYLAND
`
`COUNTY OF BALTIMORE
`
`DAVE BERTHOLD, being duly sworn, deposes and says:
`
`1.
`
`I am Senior Vice President of Sales and Operations, U.S. Generics, for Lupin
`
`Pharmaceuticals, Inc. (hereinafter “Lupin” or “Opposer”). I make this affidavit in support of the
`
`Motion for Summary Judgment brought by Lupin against Applicant Ampel, LLC in the subject
`
`action.
`
`2.
`
`I have been employed by Lupin since June 2006 and have held the position of
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`Senior Vice President of Sales and Operations, U.S. Generics= since 2015. The facts in this
`
`affidavit are based upon my personal knowledge as well as on the records, data, and documents
`
`of Lupin that I have reviewed and/or annexed hereto which are kept by Lupin in the ordinary
`
`course of its business.
`
`

`

`3.
`
`In 1968, the predecessor-in-interest of Lupin’s ultimate corporate parent, Lupin
`
`Limited, began doing business in India under the name and mark LUPIN. The word “LUPIN” is
`
`pronounced LOO-pin.
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`4.
`
`The mark LUPIN was named for the lupin flower. The lupin flower andfor seeds
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`are not used by Opposer in the manufacture of its pharmaceutical products.
`
`5.
`
`In the 19803 and 19905, the predecessors-in-interest of Lupin Limited received
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`approval from the United States Food and Drug Administration (“FDA”) to allow certain of its
`
`manufacturing facilities located in India to manufacture and distribute pharmaceutical products
`
`intended for US. consumers.
`
`6.
`
`In the early 20003, Lupin Limited filed its first of many Abbreviated New Drug
`
`Applications (“ANDA”) with the FDA. ANDAs are applications for approval by the FDA of a
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`generic version of an existing, FDA-approved drug.
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`7.
`
`On March 28, 2002, Lupin Limited filed an ANDA for the drug ceftriaxone for
`
`injection. That ANDA was approved by the FDA on September 30, 2003 and eventually became
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`the first drug marketed under the LUPIN mark in the United States. Attached hereto as Exhibit A
`
`is a true and correct copy of cover letter accompanying the ceftriaxone ANDA.
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`8.
`
`The first sales of pharmaceutical products under the trademark LUPIN (“the
`
`LUPIN Mark") in the United States occurred in July 2005.
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`9.
`
`Attached hereto as Exhibit B is a true and correct copy of a quarterly report for the
`
`third quarter of 2005 reflecting the market share of sales of ceftriaxone of Lupin in comparison to
`
`

`

`other pharmaceutical companies. Exhibit B reflects Opposer‘s sales of ceftriaxone under the
`
`LLEPIN Mark in July through September, 2005.
`
`10.
`
`Since at least as early as July 2005. pharmaceutical products bearing the LUPIN
`
`Mark have been continuously distributed, offered for sale. and sold throughout the United States.
`
`1 l.
`
`In 2003, Lupin Phamtaceuticals. Inc. was incorporated in the US. and began
`
`doing business at its headquarters in Baltimore.
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`12.
`
`Today. Lupin manufactures. offers for sale. and sells more than 150 types of
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`pharmaceutical products throughout the United States.
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`13.
`
`Lupin‘s products include both branded and generic pharmaceuticals.
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`14.
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`All of Lupin's branded and generic products are sold in packaging that bears the
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`LL’PIN mark.
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`15.
`
`Some of Lupin's drug products also bear the LUPIN mark imprinted directly on
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`the drug capsule itself.
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`16.
`
`Lupin’s pharmaceutical products treat a wide variety ofindications, including.
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`without limitation. use for the treatment of fever; headache; fatigue: confusion; chest pain:
`
`stiffness; shortness of breath; joint or muscle pain; anemia; swelling in the legs. ankles. and feet;
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`joint swelling: and rash. among other indications.
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`17.
`
`[CONFIDENTIAL]
`
`l4.)
`
`

`

`18.
`
`Since its introduction to the U.S. market. Lupin has continually expanded its
`
`pharmaceutical product offerings to new and different therapeutic areas of treatment, such as
`
`cardiology, diabetes, women’s health, and gastroenterology.
`
`19.
`
`A primary demographic of consumers of Opposer’s drug products are women of
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`childbearing age.
`
`20.
`
`Lupin sells and distributes its products through wholesalers including
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`AmeriSource Bergen, Cardinal, and McKesson, which are the country’s three largest
`
`pharmaceutical wholesalers. These Wholesalers, in turn, distribute Lupin’s pharmaceutical
`
`products bearing the LUPIN Mark to independent pharmacies, pharmacy chains, and hospitals,
`
`which distribute the products to the end consumer through an extensive network of retail
`
`outlets.
`
`21.
`
`Examples of retail outlets where LUPIN products are available to consumers
`
`include major retail chains such as CVS. Walgreens. and WalMart, as well as grocery store
`
`chains such as GIANT, Harris Teeter. Publix, and Kroger.
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`22.
`
`Lupin’s pharmaceuticals are also prescribed at and distributed through hospitals
`
`located throughout the United States.
`
`23.
`
`Lupin‘s pharmaceutical products are also offered and sold to various federal
`
`govemment agencies and programs including, without limitation, the Department of Veterans
`
`Affairs (particularly VA Hospitals), federal prisons, and through the Medicare and Medicaid
`
`programs.
`
`

`

`24.
`
`Lupin is aware that certain of its pharmaceutical products can be and are
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`“repurposed” by third parties to treat multiple symptoms of diseases other than the diseases
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`intended to be treated by such drugs.
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`25.
`
`By way of example, Lupin is aware that a number of Opposer’s pharmaceutical
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`products are capable of being used, or repurposed, by third parties, to treat certain common
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`symptoms of Lupus, including non-steroidal anti-inflammatory drugs (NSAIDS) such as
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`celecoxib, as well as corticosteroids, anti-malarials, Angiotensin-converting enzyme (ACE)
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`inhibitors, and drugs intended for the treatment of arthritis, among others. It is my
`
`understanding that such drugs have some efficacy in alleviating symptoms of Lupus.
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`26.
`
`Lupin also manufactures abacavir (antiretroviral agent), lamivudine (antiviral),
`
`statins, and zidovudine (antiretroviral agent), either alone or in combination with other
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`preparations. It is my understanding that the aforementioned drugs also have efficacy in
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`alleviating certain common symptoms of Lupus.
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`27.
`
`In fiscal year 2017, Lupin was the fourth largest generic company in the U.S, with
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`a 5.3% market share by prescriptions.
`
`

`

`28.
`
`Lupin‘s sales have grown tremendously since the 111,} PlN brand was first
`
`introduced into the (LS. market in 2005. Since 2010 Lupin has recorded the following sales
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`results (Lupin‘s fiscal year ends March 31 )2
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`2010: $348 million
`
`2011: $441 million
`
`2012: $507 million
`
`2013: $693 million
`
`2014: $803 million
`2-015: $890 million
`
`2016: $888 million
`
`2017: $1.214 billion
`
`[CONFIDENTIAL]
`
`
`
`DAVE BERTHOLD
`
`Swofli to before me this
`A day ofDecember. 2017
`
`
`
`
`./
`,1"
`‘1
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`7,; A
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`7 ,,,
`
`
`z 2» \>
`NOTARY PUBLIC
`
`CATHERINE M. CARLSON
`NOTARY PUBLIC
`BALTIMORE COUNTY
`MARYLAND
`m coumssaou EXPIRES SEPT. 23, 20 x a
`
`6
`
`

`

`IN THE U.S. PATENT AND TRADEMARK OFFICE
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`
`-----------------------------------------------------x
`LUPIN PHARMACEUTICALS, INC.,
`
` Opposer,
`v.
`
`Opposition No. 91226322
`
`AMPEL, LLC,
`
`Applicant.
`------------------------------------------------------x
`
`EXHIBIT A
`
`TO
`
`AFFIDAVIT OF DAVE BERTHOLD IN SUPPORT OF MOTION FOR SUMMARY
`JUDGMENT BY OPPOSER LUPIN PHARMACEUTICALS, INC.
`
`Exhibit A is a true and correct copy of a cover letter accompanying the Abbreviated New Drug
`
`Application (“ANDA”) submitted to the Food and Drug Administration for the drug ceftriaxone for
`
`injection. Exhibit A is designated as CONFIDENTIAL – FOR ATTORNEYS’ EYES ONLY under the
`
`Board’s Standard Protective Order, and filed under seal.
`
`

`

`IN THE U.S. PATENT AND TRADEMARK OFFICE
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`
`-----------------------------------------------------x
`LUPIN PHARMACEUTICALS, INC.,
`
` Opposer,
`v.
`
`Opposition No. 91226322
`
`AMPEL, LLC,
`
`Applicant.
`------------------------------------------------------x
`
`EXHIBIT B
`
`TO
`
`AFFIDAVIT OF DAVE BERTHOLD IN SUPPORT OF MOTION FOR SUMMARY
`JUDGMENT BY OPPOSER LUPIN PHARMACEUTICALS, INC.
`
`Exhibit B is a true and correct copy of a quarterly report for the third quarter of 2005 reflecting
`
`the market share of sales of ceftriaxone. Exhibit B is designated as CONFIDENTIAL – FOR
`
`ATTORNEYS’ EYES ONLY under the Board’s Standard Protective Order, and filed under seal.
`
`

`

`IN THE U.S. PATENT AND TRADEMARK OFFICE BEFORE THE
`
`TRADEMARK TRIAL AND APPEAL BOARD
`
`Efifiiii'fifiXfiiZXEéfifiEstfE6;"""X
`
`Opposer,
`
`Opposition No. 91226322
`
`V.
`
`AMPEL, LLC,
`
`Applicant.
`______________________________________________________x
`
`AFFIDAVIT OF JAY LISKA IN SUPPORT OF MOTION FOR SUMMARY
`
`JUDGMENT BY OPPOSER LUPIN PHARMACEUTICALS, INC.
`
`ss.:
`
`) )
`
`)
`
`STATE OF MARYLAND
`
`COUNTY OF BALTIMORE
`
`JAY LISKA, being duly sworn, deposes and says:
`
`1.
`
`I am the Director of Marketing for Lupin Pharmaceuticals, Inc. (hereinafter
`
`“Lupin” or “Opposer”). I make this affidavit in support of the Motion for Summary
`
`Judgment brought by Lupin against Applicant Ampel, LLC (hereinafter “Ampel” or
`
`“Applicant”) in the subject action.
`
`2.
`
`I have been employed by Lupin since August 2011 and have held the position
`
`of Director of Marketing since that time. The facts in this affidavit are based upon my
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`personal knowledge as well as on the records, data, and documents I have reviewed and are
`
`discussed herein and annexed hereto, all of which are kept in the ordinary course of business
`
`of Lupin.
`
`

`

`[CONFIDENTIAL]
`
`[CONFIDENTIAL]
`
`5.
`
`Lupin advertises its products under the LUPIN Mark through various channels
`
`and media platforms including: Opposer’s website at lupinpharmaceuticalscom; intemet banner
`
`ads; intemet pop-up ads; television infomercials on networks including Lifetime and Oxygen;
`
`print advertisements in medical journals and pharmaceutical trade journals, pharmaceutical
`
`bulletins, and specialty consumer medical publications; and underwriting and sponsorship of
`
`pharmaceutical and medical seminars.
`
`6.
`
`Examples of the various trade publications and medical journals in which Lupin’s
`
`

`

`pharmaceutical products have been advertised under the LUPIN Mark include: Infectious
`
`Disease in Children; Clinical Psychiatry Today; Pharmacy Times; Chain Drug Review;
`
`Contemporary OB/GYN; and the American Academy ofPediatrics Newsletter, as well as online
`
`outlets of certain of these and other publications. Since 2012, Lupin also has advertised in
`
`publications that are available to consumers either in doctors’ offices and lobbies of medical care
`
`centers, as well as directly to consumer subscribers. Such publications include ADDitude
`
`Magazine; Asthma & Allergy Today; Ready Set Grow; and Drug Topics. True and correct copies
`
`of representative samples of advertising featuring the LUPIN Mark are attached hereto as Exhibit
`
`A.
`
`7.
`
`Lupin also provides underwriting and sponsorship support to pharmaceutical and
`
`medical seminars, such as the following national meetings:
`
`0 Society of Maternal Fetal Medicine (“SMFM”) 2016 Annual Meeting in Atlanta,
`Georgia, and 2017 Annual Meeting in Las Vegas, Nevada, both attended by
`approximately two thousand (2,000) people;
`
`0 American College of Obstetrics & Gynecology (“ACOG”) 2016 Annual Meeting in
`Washington, DC and 2017 Annual Meeting in San Diego, California, both attended by
`approximately five thousand (5,000) people;
`
`0 Association of Women’s Health, Obstetric and Neonatal Nurses (“AWHONN”) 2016
`Convention in Grapevine, Texas and 2017 Convention in New Orleans, Louisiana,
`both attended by approximately three thousand (3,000) people; and
`
`0 Society of Obstetrics & Gynecological Hospitalists (“SOGH”) 2016 Annual Clinical
`Meeting in Denver, Colorado and 2017 Annual Clinical Meeting in New Orleans,
`Louisiana, both attended by approximately five hundred (500) people.
`
`Lupin also sponsors regional and local pharmaceutical and medical seminars,
`
`including the following recent conferences:
`
`- AWHONN South Carolina Division conference, held in October 2017 in Columbia,
`
`South Carolina;
`
`

`

`o AWHONN Maryland conference, held in October 2017 in Linthicum Heights,
`Maryland;
`
`0 Maryland ACOG District conference, held in October 2017 in Baltimore, Maryland;
`
`0 Maryland Society of Health System Pharmacists Fall Seminar, held in September 2017
`in Baltimore, Maryland;
`
`0 AWHONN Louisiana, held in October 2017 in Baton Rouge, Louisiana; and
`
`0 New Jersey Obstetrical & Gynecological Society Semi Annual Conference, held in
`November 2017 in Monroe Township, New Jersey.
`
`[CONFIDENTIAL]
`
`
`
`9.
`
`To the extent it is able to do so under the laws and codes of conduct governing the
`
`marketing activities of pharmaceutical companies, Lupin provides a variety of collateral
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`merchandise that features and promotes the LUPIN Mark, including such goods as mugs,
`
`reusable grocery bags, car air fresheners, memo pads, and pens. True and correct copies of
`
`representative samples of such products are attached hereto as Exhibit B.
`
`10.
`
`Lupin has retained the services of several advertising agencies as well as hundreds
`
`of vendors in conjunction with Lupin’s efforts to promote, advertise, and market pharmaceutical
`
`products under the LUPIN Mark including, by way of example, CCG Marketing Solutions, bfw
`
`Advertising, Brand Equity Rx, HealthLogiX LLC, DoctorDirectory.Com lnc., Arches
`
`

`

`Technology, Paratus Health Systems, Asembia, LLC, Atom Strategic Consulting, CoverMyMeds
`
`LLC, 3D Exhibits, Inc., and Viscadia Inc.
`
`11.
`
`As a result of Lupin’s efforts to promote its mark, the LUPIN Mark is well and
`
`favorably known, identifiring Lupin exclusively as the source or origin of a wide variety of
`
`pharmaceutical products and collateral products and services.
`
`12.
`
`Lupin also provides information to consumers through its website regarding its
`
`products and educational information on the treatment of various conditions. True and correct
`
`copies of relevant examples are attached hereto as Exhibit C.
`
`JAY LISKfSA/
`
`;
`
`S
`
`pefore me this
`ay of December, 2017
`
`'
`
`'
`
`
`
`/.{4/
`NOTARY PUBLIC
`
`
`
`

`

`IN THE U.S. PATENT AND TRADEMARK OFFICE
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`
`-----------------------------------------------------x
`LUPIN PHARMACEUTICALS, INC.,
`
` Opposer,
`v.
`
`Opposition No. 91226322
`
`AMPEL, LLC,
`
`Applicant.
`------------------------------------------------------x
`
`EXHIBIT A
`
`TO
`
`AFFIDAVIT OF JAY LISKA IN SUPPORT OF MOTION FOR SUMMARY JUDGMENT BY
`OPPOSER LUPIN PHARMACEUTICALS, INC.
`
`

`

`
`
`The Bottom Line...
`
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`
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`
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`
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`0 it is not known whether nitazoxanide is excreted in human milk. Because many drugs are excreted in human milk, ca
`exercised when nitazoxanide is administered to a nursing woman.
`' In clinical studies involving 613 HIV-uninfected pediatric patients receiving ALINIA for Oral Suspension, the most frs
`events reported regardless of causality assassment were: abdominal pain (7.8%), diarrhea (2.1%). vomiting (1.1%) ar
`These were typically mild and transient in nature. In placebo-controlled clinical trials, the rates of occurrence of that
`differ significantly from those of the placebo. None of the 613 pediatric patients discontinued therapy because of 3
`
`Please see ALINIA” Brief Summary of Prescribing Information on the adjacent page.
`Refinance: 1. ALINIA“ Prescribing lnfnrrnarlon.
`
`"Terms and conditions “Fply'
`
`ALINIA is a registered trademark of Remark Laboratories, L
`Distributed by Lupin Pharmaceuticals. int. under lIEIMfi in
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`IMP-000959
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`
`A Unique VHC* That’s
`
`lnspiraChamber
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`\ with SootherMask‘”
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`insniraChambor with InspiraMaSk
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`'5
`
`INDICATIONS Fon use
`InspiraChamber Anti-Static: Valve-Id HoiciIIIgI
`Chamber (VHC) IB intm'Irinci it.) Lm used I'Iy |Jiit|I1l1tH
`who are under the mm or Irmlnmnt‘ m ."I
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`or “(tensed henlthcari:~ [..)II'>fI.'I:'.‘.=iI<:Imi. The:- r_'II.evII:I--
`l5 Intended to be used by U'IL‘HL.‘ patients to
`administer anrmsolizuci I'T'if't'iltir’IHOfl fmm mm?
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`presaurimd Metered Dav-w IIII'IIIIQrI; (DMDJS)
`Thu it‘lti‘fl'idrld envir'ITInnmnia are‘ the home.
`hoapitals and cimica.
`
`Piease see Cautions and Notes on opposite page.
`
`For more product information,
`visit our website at
`
`www.mspirachambencom
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`lnspfiChaflber
`
`Anti-Static Valved Holding Chamber
`with SootherMask‘ and lnsniraMask
`
`Cautions:
`
`The Difference ls By Design
`
`. Do not leave lnspiraChamber“. SootherMaskl” Or InspiraMask'“ unattended with children.
`Notes:
`
`- Storage and operating range: 5°C—40°C (4i°F—iD4°F)at15-95% relative humidity.
`- Inapect the device for cracks. debris, or damage that will prevent proper function after each cleaning.
`REPLACE IMMEDIATELY if any damages are observed. Environmental conditions. storage and proper
`cleaning can affect device life span.
`- This medical device is for single-patient use.
`. The intended patient population for inspiraCharnber“ with Mouthpiece is three (3) years and older who
`have been prescribed pMDl medications.
`- The size of the SootherMask'" or lnspiraMask'" should be determined by the size of the patient's face.
`-
`if medication build-up is observed in your chamber. wash the inside of the chamber with a soft cloth
`according to the instructions for Use to ensure proper performance.
`
`For more product information. visit our website at WWMinspirachambencom
`Ill
`a LUPIN
`FHMIMtIuI‘ICAu.mI
`
`:i-I 2mi- I..UDII" Piul-mnccunmis. In:
`
`Itiiuia-VE 1215
`
`Stay Informed!
`
`ign up for TOC Alerts for the latest
`research and new: in your field
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`arsonalize your experience by creating
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`MY LIEBERT user account today at
`ww.liebertpub.comlliebertconnect
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`e your account to mark favorite jaumals
`cl articles, track citations of important
`rides. and save searches for later use.
`
`ise . Cite - Share - Submit - Subscribe
`
`
`
`LUP-000961
`
`’vwf HM W, lm._, M45244
`
`www.liebertpub.com
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`|
`
`‘ml «lama lrll‘ll'l hl‘l mulls-mi l-
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`Now Available—InSpiraCham
`
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`LUP-OOO962
`
`INDICATIONS FOR USE
`
`InspiraChamber Anti—Static Valved Holding
`Chamber (VHC) is intended to be used by patients
`who are under the care or treatment of a physician
`or licensed healthcare professional. The device
`is intended to be used by these patients. to
`administer aerosolized medication from most
`pressurized Metered Dose Inhalers (pMDIs).
`The intended environments are the home.
`hospitais and clinics.
`
`Please see Cautions and Notes on apposite page.
`
`For more produot informa tion,
`visit our Website at
`
`www. inspire chamb er. com
`
`'Valved Holding Chamber.
`
`LUPIN
`H'NMIAGIUIILMLI WE
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`31-
`InspiraChamber
`
`Anti-Static Valved Holding Ch
`With SootherMask and inspiraMask
`
`Cautions:
`
`The Difference Is By Design
`
`- Do not leave InspiraChamber‘
`Notes:
`
`.Sizmtheriviask1M or inspiraMask'“ unattended with children.
`
`' Storage and operating range: 5“C-40°C (APP—104W) at 15—95
`- Inspect the device for cracks. debris. or damage that will prev
`REPLACE IMMEDIATELY if any damages are observed. Enviro
`cleaning can affect device life span.
`* This medical device is for single-patient use.
`- The intended patient population for Insp
`have been prescribed pMDI medications.
`- The size of the .‘Sootheriviaslt'M or inspiraMask’” should be determined by the size of the patient's face.
`'
`If medication buiid~up is observed in your chamber. wash the inside of the chamber with a soft cloth
`according to the Instructions for Use to ensure preper performance.
`
`96 relative humidity.
`ent proper function after each cleaning.
`nmental conditions. storage and proper
`
`iraChamber" with Mouthpiece is three (3) years and older who
`
`For more product information, visit our website at www.mspirachamber: com
`
`..LUPIN
`mmmsuumuuc.
`
`m HUI!) lupin Pliuffilm'llulicnlh. Inr
`
`ir' line-w. IJJJS
`
`
`
`Stay Informed!
`
`Sign up for TOC Alerts for the latest
`research and news in your field
`
`Persooaiize your experience by creating
`a __t MYLIEBEHT user account today at
`www.liebertpub.com/Ilebertconnect
`
`Use your account to mark favorite journals
`and articles, track citations of important
`articles, and save searches for later use.
`
`Use - Cite . Share - Submit - Subscribe
`
`E96000'dl’1']$3: ifE ff
`
`www.liebertpub.con1
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`Methylphenidate HCI®
`Chewable Tablets
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`MPORTANT SAFETY INFORMATION
`'NIDICATION
`
`iethylphenidate Hydrochloride Chewable Tablets are a central
`ervous system stimulant prescription medicine that are used for
`is treatment of Attention Deficit and Hyperactivity Disorder (ADHD).
`
`
`DRUG ABUSE AND DEPENDENCE
`irlethylphenidate Hydrochloride Chewable Tablets should be given
`
`:autiously to emotionally unstable patients. such as those with a
`
`tistory of drug dependenCe or alcoholism. because such patients
`
`nay increase dosage on their own initiative.
`
`:hronicaliy abusive use can lead to marked tolerance and psychic
`
`lependence with varying degrees of abnormal behavior. Frank
`
`isycholic episodes can occur, especially with parenteral abuse.
`
`tareful supervision is required during drug withdrawal. since severe
`
`lepression as well as the effects of chronic overactivity can be
`
`inmasked. Long-term fOIIDWHLlD may be required because of the
`
`elient's basic personality disturbances.
`
`Aethylphenidate HCI Chewable Tablets are contraindicated:
`- in patients with marke
`Hun-u Ann- mn. .
`
`d anxiety. tension. and agitation. since
`
`~ During treatment with monoamine oxidase inhibitors (Mr
`and also within a minimum of 14 days following discontinue
`of an MAOI (hypertensive crises may result).
`
`- Children. adolescents. or adults who are being considers:
`treatment with stimulant medications should have a careful his
`(including assessment for a family history of sudden deat
`ventricular arrhythmia) and physical exam to assess for
`presence of cardiac disease. and should receive iurther car
`evaluation if findings suggest such a disease.
`
`
`
`This product should be taken with at least 3 ounce
`(a full glass) of water or other fluid. Taking this produ-
`wlthout adequate fluid may cause it to swell and caus
`choking. If your patient experiences chest pain. vomiting. c
`difficulty in swallowing or breathing after taking this produc
`they should seek immediate attention.
`
`
`
`
`
`- Sudden death has been reported in children and adolesct
`with structural cardiac abnormalities or other serious heart proble
`Sudden death. stroke. and myocardial
`infarction have bi
`reported in adults taking stimulant drugs at usual doses for ADl
`
`LUP-000964
`
`

`

`idate HCIE Chewable IR Tablets,
`
`go.
`
`l'iliig for a pi‘ilier'ii i'ir..--=.-viy r:'li.:i=:_1nr-_i
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`Chewable Tablets
`aerate-Release Chewable Tablet available"
`
`iorrnulatipn kids may preler“"'
`
`Chewable tablets!
`
`’ INFORMATION CONT'D
`
`stimulants may
`of
`Administration
`behavior disturbance and thought
`ore-existing psychotic disorder.
`nitlating treatment with a stimulant.
`depressive Symptoms
`should be
`tetermine it they are at risk for bipolar
`em for possible induction of a mixed!
`lienlS.
`
`notic Or manic syntptOms: Treatment—
`manic symptoms
`in children and
`or history of paychotic illness or mania
`.nts at usual doses.
`painful erections have been reported
`i both pediatric and adult patients.
`bnormaliy sustained or frequent and
`seek immediate medical attention.
`
`lines may cause suppression oi growth.
`.ored during treatment with stimulants.
`.growing or gaining height or weight as
`ave their treatment interrupted.
`ADHD are associated with peripheral
`
`including Raynaud's phenomenon. Signs and
`vasculooaihy,
`symptoms generally improve after
`reduction in dose or
`discontinuation or drug. Careful Observation for digital changes
`is necessary during treatment with ADHD stimulants.
`- Nervousness and insomnia are the most common adverse
`reactions but are usually controlled by reducing dosage and
`omitting the drug in the afternoon or evening. Other reactions
`include hypersensitivity:anorexia: nausea; dizziness; palpitations:
`headache; dyskinesia; drowsiness; blood pressure and pulse
`changes; tachycardia; angina; cardiac arrhythmia: abdominal
`pain: weight loss during prolonged therapy: libido changes; and
`rhabdomyolysis.
`. Methylphenidate Hydrochloride Chewable Tablets should not
`be used in children under six years. since safely and efficacy In
`this age group have not been established.
`- Adequate studies to establish safe use at Methyiphenidate HCi
`Chewable Tablets during pregnancy have not been conducted.
`Patients should be advised to tell their physicians it they are
`pregnant. planning to become pregnant. or breastfeeding.
`Please see Brief Summary of Full Prescribing information on
`the following page.
`
`" JonntimiiFt Stew-3m. MD MPH
`Amtinrlrfltt‘ll ritlcl Lhdliruttjlcl.
`ll Deliciirl-lvtit-‘iarrrvrlv [ii-spider Clinical
`D. Priin Cu'tlr'.‘Cniilll-Iillfill CNS Disriirl wit-l; l5i2i PCCl2i0l472.
`E. Witt-rm MU, anti Theodore.- A Storm. M
`'i Vl‘l Pit-rim.“ l'.‘lll.ll,.r’ll‘y
`ult- T.i|'ilt'ts1p..rclmrie lll‘:("ll| bplilrrl'rul NJ C
`" Mr>1try|ptierirrlnitr l‘lvtll'OCllifllldF Cliewril
`{LlElrLtlLlV-'slilIIJIHr‘QtItZ-IJI'II,” Dr'r:t.-.'lll|.ll:-i Dillfi.
`- Fnori and Drug Administration \‘JC'l)'«i|iE‘. lilltiriww'rmrtusstlut
`tor Htinmri Us“ tCHMi‘Ji. Eirruperir‘i Merit: inc“. Agenrv Fritz-Hermon l‘tlIJW
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`|)()|?Ll|r]llhll (EMEARCHMPJF'ECi.‘|':MEllt).20053
`[lrlfllilrlilll'
`| Journal in! Asthma (2007.). vol. 3'3. No 5. p 391403.
`
`I!) LU PIN
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