`DEPARTMENT OF HEALTH AND HUMAN SERVICES 1. Date Submitted
`3. NDA/ANDA/AADA or BLAIPMA
`Type: DA
`Number: 202236
`Food and Drug Administration
`06/ 17/2015
`~ Single product 0 Multiple products
`TRANSMITTAL OF ADVERTISEMENTS
`For multiple products, submit completed form and
`AND PROMOTIONAL LABELING FOR
`specimen of advertising/promotional materials to
`DRUGS AND BIOLOGICS
`one application of choice, and attach separate
`sheet addressing items 3-5 for remainder of
`FOR HUMAN USE
`products. Refer to No. 3 on instruction sheet.
`
`2. Label Review Number
`(Biologics)
`
`NOTE: Fonn FDA 2253 is required by law. Reports are required for approved NDAs and ANDAs (21 CFR 314.81).
`4. Proprietary Name
`5. Established Name
`azelastine hydrochloride and fluticasone propionate
`
`DYMISTA
`
`6. Package Insert Date and ID Number
`(Latest final printed labeling)
`
`IN-023A6-05
`
`02/2015
`
`Product Code No.:
`7. Manufacturer Name
`MEDA Pharmaceuticals Inc.
`
`Ucense No. (Biologics):
`
`8.
`Advertisement I Promotional Labeling Materials
`a. Please check only one: 0 Professional
`I8J Consumer
`Dissemination/
`Material Type
`Publication
`(use FDA codes)
`Date
`c.
`0612212015
`
`b.
`www-banner
`
`d.
`USIOYM/0515/0073
`
`e.
`Competitive' Flonasc Banner: 300 x 250
`
`MateriaiiD Code
`
`Material Description
`
`Delete
`Row
`
`f. Comments
`
`To delete a row, cllcl< the 'Delete Row· bvtton for that row (or press the enter key
`
`if yov 've tabbed into the bvtton). You cannot delete the last remaining row. I Add New Row I
`
`COPY
`
`10. Responsible Official's (or Agent's)
`a. Telephone Number (lnclvde area code)
`
`732-564-2284
`
`b. FAX Number (Include area code)
`
`732-564-23 77
`
`c. Email Address
`
`lorna-jane.breme a1meda.us
`
`9. Applicanfs (or Agenfs) Return Address
`Address 1 (Street address, P. 0 . box. company name c/o)
`Meda Pharmaceuticals Inc.
`
`Address 2 (Apartment, suite, unit, buildmg, ffoor. etc.)
`265 Davidson venue
`
`City
`omerset
`
`Country
`USA
`
`I Stale/Province/Region
`ew Jersey
`
`l ZIP or Postal Code
`
`08873-4120
`
`11 . Typed Name and Tille of Responsible Official or Agent 12. Signature of Responsible Official or Agent
`
`13. Date
`
`Lorna-Jane Bremer. enior Director Regulatory
`Affairs
`
`14. For CBER Products Only (Check one)
`
`0 Draft
`FORM FDA 2253 (12114) PREVIOUS EDITION IS OBSOLETE
`
`v
`
`J~_I) z,~gn I 06/ 17/2015
`0 Flnal
`Page 1 of 2
`~-------
`PLAINTIFFS'
`TRIAL EXHIBIT
`
`HIGHLY CONFIDENTIAL
`-SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`PTX0914
`
`MEDA_APTX0347 4265
`
`PTX0914-0000 1
`
`1
`
`CIP2083
`Argentum Pharmaceuticals LLC v. Cipla Ltd.
`IPR2017-00807
`
`
`
`This section applies only to requirements of the Paperwork Reduction Act of 1995.
`•Do NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.•
`The burden time for this collection of information is estimated to average 2 hours per response, including
`the time to review instructions, search existing data sources, gather and maintain the data needed and
`complete and review the collection of information. Send comments regarding this burden estimate or any
`other aspect of this information collection, including suggestions for reducing this burden, to:
`Department of Health and Human Services
`Food and Drug Administration
`Office of Chief Information Officer
`Paperwork Reduction Act (PRA) Staff
`PRAStaff@fda.hhs.gov
`"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
`information unless it displays a currently valid OMB number. "
`
`FORM FDA 2253 (12114) PREVIOUS EDITION IS OBSOLETE
`
`Page 2 of 2
`
`HIGHLY CONFIDENTIAL
`-SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`MEDA_APTX0347 4266
`
`PTX0914-00002
`
`2
`
`
`
`US/DYM/0515/0073- Final2.0- 2.44 MB- Competiti e
`
`Flonase Banner: 300x250
`
`Page 1 of 16
`
`ATTENTION FLONASE USERS
`
`CUCKHERE
`
`IF YOUR NOSE NEEDS
`
`MORE HELP THAN IT'S GETTING
`
`1
`
`https://www.zincmapsmedapharma.com/Re iew/ Artwork.Re iewOnline.aspx?ViewOnly=t.. . 6/ 16/2015
`
`HIGHLY CONFIDENTIAL
`-SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`MEDA_APTX03474267
`
`PTX0914-00003
`
`3
`
`
`
`US/DYM/0515/0073- Final2.0- 2.44 MB- Competitive
`
`Flonase Banner: 300x250
`
`Page 2 of 16
`
`https://www.zincmapsmedapharma.com/Review/ ArtworkReviewOnline.aspx?ViewOnly=t... 6116/201 5
`
`HIGHLY CONFIDENTIAL
`-SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`MEDA_APTX03474268
`
`PTX0914-00004
`
`4
`
`
`
`U /DYM/0515/0073- Final 2.0- 2.44 MB- Competiti e s Flonase Banner: 300x250
`
`Page 3 of 16
`
`ASK YOUR DOCTOR FOR
`
`DYMISTA
`
`DYMISTA HAS
`
`THE SA E ACTIVE INGREDIENT
`
`https://www.zincmapsmedapharma.com/Review/ Artwork.Re iewOnl ine.aspx?ViewOnly=t... 6116/2015
`
`HIGHLY CONFIDENTIAL
`-SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`MEDA_APTX03474269
`
`PTX0914-00005
`
`5
`
`
`
`U /DYM/0515/0073- Final2.0- 2.44 MB- Competitive vs Flona e Banner: 300x250
`
`Page 4 of 16
`
`https://www.zincmapsmedapharma.com!Review/ Artwork:ReviewOnJ ine.aspx?ViewOnly=t... 6/16/2015
`
`HIGHLY CONFIDENTIAL
`-SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`MEDA APTX03474270
`-
`
`PTX0914-00006
`
`6
`
`
`
`U /DYM/0515/0073- Final2.0- 2.44 MB- Competiti e vs Flonase Banner: 300x250
`
`Page 5 of 16
`
`ASFLONASE
`(FLVTICASONE PROPIONATE)
`
`PLUS AN ANTIHISTAMINE
`
`FOR RELIEF AS FAST AS
`
`JO MINUTES FOR MOST PEOPLE
`
`https://www.zincmapsmedapharma.com/Re iew/ ArtworkRe iewOn line.aspx?ViewOnl =t... 6116/2015
`
`HIGHLY CONFIDENTIAL
`-SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`MEDA_APTX0347 4271
`
`PTX0914-00007
`
`7
`
`
`
`US/DYM/0515/0073- Final2.0- 2.44 MB- Competitive s Flonase Banner: 300x250
`
`Page 6 of 16
`
`https://www.zincmapsmedapharma.com/Review/ ArtworkRe iewOnline.a px?ViewOnly=t... 6/ 16/2015
`
`HIGHLY CONFIDENTIAL
`-SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`MEDA_APTX03474272
`
`PTX0914-00008
`
`8
`
`
`
`US/DYM/0515/0073 -Final 2.0- 2.44 MB - Competitive vs Flonase Banner: 300x250
`
`Page 7 of 16
`
`GET MORE •.•
`
`AND PAY LESS AT THE STORE.
`
`WHY WAIT?
`
`https://www.zincmapsmedapharma.com/Review/ ArtworkRe iewOnline.aspx?ViewOnl =t... 6/16/2015
`
`HIGHLY CONFIDENTIAL
`-SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`MEDA_APTX03474273
`
`PTX0914-00009
`
`9
`
`
`
`U /DYM/05 1 5/0073 - Final 2.0 - 2.44 MB - Competitive vs Flona e Banner: 300x250
`
`. .
`
`Page 8 of 16
`
`https://www.zincmapsmedapharma.com/Review/ ArtworkReviewOnline.aspx?ViewOnly=t... 6116/2015
`
`HIGHLY CONFIDENTIAL
`-SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`MEDA_APTX03474274
`
`PTX0914-0001 0
`
`10
`
`
`
`US/DYM/0515/0073-
`
`..
`
`inal2.0- 2.44 MB- Comp titi e vs Flonase Banner: 300x250
`
`Page 9 of 16
`
`ASK YOUR DOCTOR ABOUT
`
`DYMISTA
`
`I
`
`AND GET MORE.
`
`DYMISTA
`
`DYMISTA
`
`BY PRESCRIPTION ONLY
`
`DYMISTA
`I
`
`BY PRESCRIPTION ONLY
`
`https://www.zincmapsmedapharma.com/Re
`
`iew/ Artwork.ReviewOnline.aspx?ViewOnly=t... 6/16/2015
`
`HIGHLY CONFIDENTIAL
`-SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`MEDA_APTX0347 4275
`
`PTX0914-00011
`
`11
`
`
`
`US/DYM/0515/0073 - Final 2.0 - 2.44 MB - Competitive s Fiona e Banner: 300x250
`
`Page 10 of 16
`
`, ......,.. ..... _ . ._ : . . - . . ...
`
`, __ ...._,..~,
`
`https://www.zincmapsmedapharma.com/Re iew/ArtworkReviewOnline.aspx?ViewOnly=t... 6/ 16/2015
`
`HIGHLY CONFIDENTIAL
`-SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`MEDA_APTX03474276
`
`PTX0914-00012
`
`12
`
`
`
`US/DYM/0515/0073- Final 2.0- 2.44 MB- Competiti e
`
`Flonase Banner: 300x250
`
`Page 11 of 16
`
`DYMISTA
`
`d
`
`BY PRESCRIPTION ONLY
`
`DYMISTA
`
`II
`
`BY PRESCRIPTTON ONLY
`
`DYMISTA
`
`BY PRESCRIPTION ONLY
`
`DYMISTA
`
`II
`
`BY PRESCRIPTION ONLY
`
`https://www.zincmapsmedapharma.com/Review/ Art
`
`orkRe iewOnline.aspx?ViewOnly=t... 6/16/2015
`
`HIGHLY CONFIDENTIAL
`-SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`MEDA_APTX0347 4277
`
`PTX0914-00013
`
`13
`
`
`
`U /DYM/0515/0073 - Final 2.0 - 2.44 MB - Competitive vs Flonase Banner: 300x250
`
`...
`
`Page 12ofl6
`
`-
`
`https://www .zincrnapsmedapharma.com/Revie I ArtworkRe iewOnline.aspx?ViewOnly=t... 6/16/2015
`
`HIGHLY CONFIDENTIAL
`-SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`MEDA_APTX03474278
`
`PTX0914-00014
`
`14
`
`
`
`US/DYM/0515/0073- Final 2.0- 2.44 MB- Competitive s Flonase Banner: 300x250
`
`~ . ' .
`
`Page 13 of 16
`
`DYMISTA
`
`BY PRESCRIPTION ONLY
`
`c.. .... -~ vo<-l-.lpnghl_
`• __ . , ._ ..... ., .......... _
`..,.. .. 10<1
`
`-.......... """""" -
`
`DYMISTA
`
`BY PRE CRIPT/ON ONLY
`
`.,.IIIIEr:WDDt"'e'lyO..cr
`• .. .,)Q.I"OI::IcO'i)OI.,....
`ra:oo.l'\:ll;c~ r,.... .. -.::tatd ~
`oltvritta- ~ Fa...,...-...... -""
`w,.,..-..--.. ..... - (cid:173)
`~"'..-
`...... ..-.., ,_...,.,., .... 0 0...,.,.., modo
`nr.oo .
`
`DYMISTA
`
`BY PRESCRIPTION ONLY
`
`DYMISTA
`
`BY PRESCRIPTION ONLY
`
`https://www.zincmapsmedapharma.com/Review/ Artv orkReviewOnline.aspx?ViewOnly=t... 6/16/2015
`HIGHLY CONFIDENTIAL
`MEDA_APTX03474279
`-SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`PTX0914-00015
`
`7
`
`15
`
`
`
`•
`
`Flonase Banner: 300x250
`
`Page 14 of 16
`
`US/DYM/0515/0073 -Final 2.0 - 2.44 MB - Competiti e
`,, .. .__
`
`II
`
`•
`
`I
`
`https:/ /www.zincmapsmedapharma.com/Re iew/ ArtworkReviewOnJ ine.aspx?ViewOnly=t... 6116/2015
`
`HIGHLY CONFIDENTIAL
`-SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`MEDA_APTX0347 4280
`
`PTX0914-00016
`
`16
`
`
`
`U /DYM/0515/0073 - Final 2.0 - 2.44 MB - Competitive s Flonase Bann r: 300x250
`
`Page 15 of16
`
`•
`
`fl
`
`I
`
`..
`
`DYMISTA
`
`li
`
`BY PRESCRIPTION ONLY
`
`DYMISTA
`
`I
`
`BY PRESCRIPTION ONLY
`
`https://www.zincmapsmedapharma.com/Re iew/ ArtworkReviewOnline.aspx?ViewOnl =t. .. 6/16/2015
`
`HIGHLY CONFIDENTIAL
`-SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`MEDA_APTX03474281
`
`PTX0914-00017
`
`17
`
`
`
`US/DYM/0515/0073- Final2.0- 2.44 MB- Competitive s Flonase Banner: 300x250
`
`, . . .
`
`Page 16 of 16
`
`http ://www.zincmapsmedapbarma.com/Re iew/ArtworkRe iewOnline.aspx?ViewOnly=t... 6/16/2015
`
`HIGHLY CONFIDENTIAL
`-SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`MEDA_APTX03474282
`
`PTX0914-00018
`
`18
`
`