October 10, 2002
`
`BANNER
`PHARMACAPS
`
`>
`
`PTF
`
`Dockets Management Branch (HFA-305)
`Food and Drug Administration
`Department of Health and Human Services
`5630 Fishers Lane
`Room 1061
`Rockville, MD 20852
`
`CITIZEN PETITION
`
`Dear Sir or Madam: |
`
`This Citizen’s Petition is submitted by the undersigned on behalf of Banner
`Pharmacaps, Inc. under the authority of 21 CFR §10.30, 21 CFR §314.93, and
`Section 505(j(2)(C) of the Federal Food, Drug, and Cosmetic Act. The petitioner
`is requesting that the Food and Drug Administration permit the filing of an
`Abbreviated New Drug Application for a proposed drug product that has the
`same active ingredient,
`is of the same strength, and is expected to have the
`same therapeutic effect as that of a Reference Listed Drug in the FDA's
`“Approved Drug Products with Therapeutic Equivalence Evaluations” publication,
`but differs in dosage form.
`
`A. Action Requested
`
`By this petition, the Commissioner of the Food and Drug Administration is being
`requested to declare that:
`
`(1) A new drug application for Naproxen Sodium, 220 mg (equivalent to 200 mg
`Naproxen) soft gelatin capsules is suitable for submission as an Abbreviated
`New Drug Application (ANDA), pursuant to 21 CFR §314.94;
`
`(2) The Reference Listed Drug (RLD) on which the contents of this petition is
`based is Bayer Corporation’s Aleve® (Naproxen Sodium, 220 mg) tablets;
`
`(3) Therefore, a request is being made to change the dosage form from tablet to
`soft gelatin capsule.
`
`AG P.0¥73
`
`-
`
`OL
`
`GB Bannee PHARMACAS INC
`CALTFORNIA
`
`High Poivt, NC 27261-2210
`4}25 Premier Drive
`PQ Bax 2210
`NortH CaROLina
`CANADA
`MeExica
`
`336 812 A700
`Prone
`NETHERLANDS
`
`Fax
`INubaA
`
`776 Rid S777
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1021, Pg. 1 of 16
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1021, Pg. 1 of 16
`
`

`

`At this time, the undersigned is also requesting a waiver of the requirementto
`conduct pediatric studies in accordance with 21 CFR §314.55(c)(2). The basis
`for this requestis that:
`
`(1) The effectiveness of the proposed drug product can be extrapolated from
`adequate and well-controlled studies in adult and pediatric populations;
`
`(2) The dosing and safety data for relevant age groups is well-defined;
`
`(3) The innovator product has a long history of use in ages 12-17 as an OTC
`drug (first approved as an oral tablet January 11, 1994);
`
`(4) The drug product is not labeled with dosage recommendations in children
`less than 12 years old.
`
`B. Statement of Grounds
`
`Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act allows for the
`submission of an Abbreviated New Drug Application for a proposed new drug
`product that differs in dosage form from that of the Reference Listed Drug on
`which it
`is based, provided that the Commissioner of Food and Drugs has
`approved a petition,
`filed by or on behalf of the applicant,
`requesting a
`declaration that an application to market a drug product with such change is
`suitable for an ANDA submission.
`
`The Commissioner of Food and Drugs has previously approved ANDAsuitability
`petitions of this nature, in particular, those in which the petitioners have sought to
`change the dosage form in order to make an alternate dosage form available for
`those whohavedifficulty swallowing tablets or simply prefer the alternative.
`
`In support ofthis petition, the following information is being provided:
`
`(1) The proposed drug product is a soft gelatin capsule with the same active
`ingredient, the same strength, and the sameroute of administration as that of
`the RLD, Aleve® (Naproxen Sodium, 220 mg) tablets. A copy of the most
`recent Orange Booklisting of “Approved Drug Products with Therapeutic
`Equivalence Evaluations”is provided. (Attachment 1)
`
`(2) The proposed drug productwill be labeled with the same conditions of use as
`the RLD for consumers 12 years of age and older, and is expected to have
`the same therapeutic effect when used as indicated in the labeling. A copy
`of the RLD labeling is provided. (Attachment 2)
`
`fP Baywen ParMacaps Inc
`CALIFORNIA
`
`4625 Premier Drive Hich Point, NC 27261-2210
`PO Box 2210
`NorrhH CAgOLina
`CANADA
`MEXICO
`
`336 812 8700
`PuHone
`NETHFRLANDS
`
`436 812 8777
`Fax
`INDIA
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1021, Pg. 2 of 16
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1021, Pg. 2 of 16
`
`

`

`(3) Labeling for the proposed drug product and the RLD will differ with respect to
`dosage form, inactive ingredients, and manufacturer/distributor identification
`and contact information. A draft of the proposed drug product labeling is
`provided. (Attachment 3)
`
`C. Environmental Impact
`
`The applicant claims a categorical exclusion under 21 CFR §25.31.
`
`D. Economic Impact
`
`Information will be provided upon request of the Commissioner.
`
`E. Certification
`
`the
`to the best knowledge and belief of
`The undersigned certifies that,
`undersigned, this petition includes all information and views on whichthe petition
`relies, and that
`it
`includes representative data and information known to the
`petitioner, which are unfavorable to the petition.
`
`Respectfully submitted by:
`
`Dew)
`
`Donna Lee, R.Ph.
`Director of Regulatory Affairs and Project Management
`Phone: (800) 447-1140 ext. 3312
`
`(3) Attachments
`
`ie
`
`ef Banner PharMacaps INC
`CALIFORNIA
`
`4125 Premier Drive Hicn Point, NC 27261-2210
`PO Box 2210
`NortH CAROLINA
`CANADA
`Mexico
`
`336812 8700
`PuHone
`NETHERLANDS
`
`336 B12 8777
`Fax
`India
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1021, Pg. 3 of 16
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1021, Pg. 3 of 16
`
`

`

`ATTACHMENT1
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1021, Pg. 4 of 16
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1021, Pg. 4 of 16
`
`

`

`Active Ingredient Search
`
`Page 1 of L
`
`Active Ingredient Search Results from "OTC"table for query on “naproxen.”
`
`
`
`Appl
`
`Active
`
`Ingredient
`
`Name
`
`
`
`
`
`RLD
`[. No
`Strength
` Proprietary
`
`
` Applicant
`020204 [ves] NAPROXEN SODIUM
`[EQ 200MG AEE | BAYER
`Tablet; Oral
`
` He
` ELL
`_
`
`
`
`BASE
`020204
`NAPROXEN
`[EQ 200MG
`075168
`SODIUM
`BASE
`——
`NAPROXEN
`[EQ 200MG
`074646
`SODIUM
`BASE
`ne
`
`
`074635 NAPROXEN_|ILEINERNAPROXEN SODIUM Tablet; Oral [EQ 200MG
`—
`BASE
`SODIUM
`
`NAPROXEN SODIUM
`
`NAPROXEN SODIUM
`
`
`
`Tablet; Oral
`
`Tablet; Oral
`
`
`
`|[pR REDDYS
`LABS INC
`__|lINVAMED
`
`O74661)INo NAPROXEN SODIUM
`
`——
`
`‘[ratiet: Oral
`
`jJEQ 200MG
`
`BASE
`
`NAPROXEN
`
`SODIUM
`
`PERRIGO
`
`074789 NAPROXEN_|[PvT FORMNAPROXEN SODIUM Tablet; Oral [EQ 200MG
`
`
`PS
`BASE
`SODIUM
`:
`
`
`
`
`
`021076)lYes ||INAPROXEN SODIUM;
`PSEUDOEPHEDRINE
`HYDROCHLORIDE
`
`Tablet,
`Extended
`Release;
`Oral
`
`ALEVE COLD
`EQ 200MG
`BASE;120MG |JJAND SINUS
`
`|/BAYER
`
`Thank you for searching the-Electronic Orange Book
`
`Return to Electronic Orange Book Home Page
`
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/tempai.cfm
`
`10/9/02
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1021, Pg. 5 of 16
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1021, Pg. 5 of 16
`
`

`

`Active Ingredient Detail Record Search
`
`Page 1 of 1
`
`Search results from the "OTC"table for query on "020204."
`
`.
`
`Active Ingredient:
`Dosage Form;Route:
`Proprietary Name:
`Applicant:
`Strength:
`Application Number:
`Product Number:
`
`Approval Date:
`Reference Listed Drug
`RX/OTC/DISCN:
`
`NAPROXEN SODIUM
`Tablet; Oral
`ALEVE
`BAYER
`EQ 200MG BASE
`020204
`002
`
`JAN 11, 1994
`Yes
`OTC
`
`Patent and Exclusivity Info for this product: Click Here
`
`
`
`
`Thank you for searching the Electronic Orange Book!
`
`Returnto Electronic. OrangeBookHome Page
`
`http:/Awww.accessdata. fda.gov/scripts/cder/ob/docs/tempaidet.cfm?ApplNo=020204&TABL... 10/8/02
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1021, Pg. 6 of 16
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1021, Pg. 6 of 16
`
`

`

`ATTACHMENT2
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1021, Pg. 7 of 16
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1021, Pg. 7 of 16
`
`

`

`PDR®Electronic Library(TM)- Print-Ready Document
`
`Page 1 of 5
`
`PDRfor Nonprescription Drugs® and Dietary Supplements™entry for
`
`ALEVE®(Bayer Consumer)
`
`All Day Strong
`naproxen sodium tablets, 220 mg
`Pain reliever/fever reducer
`
`ALEVE® Caplets * , Gelcaps ** , or Tablets
`Naproxen Sodium Tablets, USP
`
`Active Ingredient:
`(in each tablet/caplet/gelcap)
`
`Purpose:
`
`Naproxen sodium 220 mg (naproxen 200 mg)...........0.04 Pain reliever/Fever reducer
`
`Uses: Temporarily relieves minor aches and pains dueto:
`
`common cold
`headache
`toothache
`muscular aches
`backache
`menstrual cramps
`minorpain ofarthritis
`
`temporarily reduces fever
`
`Warnings: Allergy Alert: Naproxen sodium maycausea severeallergic reaction which may include:
`
`e hives
`e
`facial swelling
`e asthma (wheezing)
`e shock
`
`If you consume3 or more alcoholic drinks every day, ask your doctor whether yous
`Alcohol warning:
`take naproxen sodiumorother pain relievers/fever reducers. Naproxen sodium may cause stomach bleed
`
`Do not use if you have ever had anallergic reaction to any other pain reliever/fever reducer
`
`Ask a doctor before use if you have had serious side effects from any pain reliever/fever reducer
`
`Ask a doctor or pharmacist before use if you are
`
`taking any other productthat contains naproxen sodium or any otherpain reliever/fever reducer
`e
`taking other drugs on a regular basis
`e
`« under a doctor's care for any continuing condition
`
`Stop use and ask a doctorif:
`
`http://www.thomsonhe.com/pdrel/librarian/CommandSyne/032D08C0-CD29-131A-FD4B-Bé... 10/9/02
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1021, Pg. 8 of 16
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1021, Pg. 8 of 16
`
`

`

`PDR® Electronic Library(TM)- Print-Ready Document
`
`.
`
`Page 2 of 5
`
`an allergic reaction occurs. Seek medical help right away.
`any new or unexpected symptomsoccur
`symptoms continue or worsen
`you have difficulty swallowing orit feels like the pill is stuck in your throat
`you develop heartbum
`stomach pain occurs with use of this product or if even mild symptomspersist
`pain worsensorlasts for more than 10 days
`fever lasts for more than 3 days
`painful area is red or swollen
`
`If pregnant or breast-feeding, ask a health professionalbefore use.It is especially important notto use
`naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor be
`it may cause problemsin the unborn child or complications during delivery.
`
`Keep out of reach of children.
`right away.
`
`Directions:
`
`In case of overdose, get medical help or contact a Poison Control Cente
`
`e do not take more than directed
`e drink a full glass of water with each dose
`
`ALEVE® Caplets
`
`
`Over age 65 ||] caplet every 12 hours. Do not exceed 1 caplet
`in 12 hours, unless directed by a doctor.
`
`12-65 years
`|take 1 caplet every 8 to 12 hours. For the first
`
`dose you maytake 2 caplets within the first hour.
`Do not take more than 2 caplets in any 8 to 12
`
`hours, or 3 caplets in a 24 hour period, The
`
`
`smallest effective dose should be used.
`
`
`under 12
`years
`
`* ask a doctor
`
`.
`
`ALEVE® Gelcaps
`
`Over age 65 |/1 gelcap every 12 hours. Do not exceed 1 gelcap
`in 12 hours, unless directed by a doctor.
`
`||take 1 gelcap every 8 to 12 hours. Forthefirst
`dose you may take 2 gelcaps within thefirst
`hour. Do not take more than 2 gelcaps in any 8
`to 12 hours, or 3 gelcaps in a 24 hour period.
`The smallest effective dose should be used.
`
`12-65 years
`
`
`
`
`
`
`
`¢ ask a doctor
`under 12
`years
`
`
`
`ALEVE® Tablets
`
`http://www .thomsonhc.com/pdrel/librarian/CommandSyne/032D08C0-CD29-131A-FD4B-Bé., 10/9/02
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1021, Pg. 9 of 16
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1021, Pg. 9 of 16
`
`

`

`PDR® Electronic Library(TM)- Print-Ready Document
`
`Page 3 of 5
`
`
`
`
`Over age 65 |/1 tablet every 12 hours. Do not exceed 1 tablet in
`
`
`12 hours, unless directed by a doctor.
`12-65 years
`|jtake 1 tablet every 8 to 12 hours. Forthe first
`
`-|ldose you may take 2 tablets within the first hour.
`Do not take more than 2 tablets in any 8 to 12
`
`hours, or 3 tablets in a 24 hour period. The
`smallest effective dose should be used.
`
`
`
`
`under 12
`years
`
`* ask a doctor
`
`Other Information:
`
`e store at 20-25°C (68-77°F)
`e avoid high humidity and excessive heat 40°C (104°F)
`
`ALEVE® Caplets
`
`« each caplet contains: sodium 20 mg
`
`ALEVE®Gelcaps
`
`e each gelcap contains: sodium 20 mg
`
`ALEVE® Tablets
`
`e each tablet contains: sodium 20 mg
`
`Inactive Ingredients:
`
`ALEVE® Caplets: Magnesium stearate, microcrystalline cellulose, opadry YS-1-4215, povidone,talc.
`
`ALEVE® Gelcaps: D&C yellow #10 lake, disodium EDTA,edible ink, FD&C blue #1, FD&C yellow#
`lake, gelatin, glycerin, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose,
`polyethylene glycol, povidone,stearic acid, talc, titanium dioxide, triacetin.
`
`ALEVE® Tablets Magnesium stearate, microcrystalline cellulose, opadry YS-1-4215, povidone,talc.
`
`* capsule-shaped tablet(s)
`** gelatin coated capsule-shapedtablet(s)
`
`How Supplied:
`
`ALEVE® Caplets in boxes of 8, 24, 50, 100, 150, 200.
`
`ALEVE® Gelcapsin boxes of 20, 40, 80.
`
`ALEVE® Tablets in boxes of 24, 50, 100, 150.
`
`http:/Awww.thomsonhe.com/pdrel/librarian/CommandSync/032D08C0-CD29-131A-FD4B-Bé.. 10/9/02
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1021, Pg. 10 of 16 ©
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1021, Pg. 10 of 16
`
`

`

`PDR®Electronic Library(TM)- Print-Ready Document
`
`Page 4 of 5
`
`Questions or comments? call 1-800-395-0689 or www.aleve.com
`
`Donotuse if carton is open orif foil seal imprinted with "Safety SOQUEASE ®"on bottle opening is miss
`or broken.
`
`Distributed by
`
`Bayer Corporation
`
`PO Box 1910
`
`Morristown, NJ 07962-1910 USA
`
`B-R LLC
`Read Consumer
`
`Leaflet Before Use
`
`PRODUCT PHOTO(S):
`
`NOTE:These photos can be used only for identification by shape, color, and imprint. They do not depict
`actual or relative size.
`
`The product samples shown here have been supplied by the manufacturer and reproduced in full color by
`as a quick-reference identification aid. While every effort has been madeto assure accurate reproduction,
`please rememberthat any visual identification should be considered preliminary. In cases ofpoisoning o1
`suspected overdosage,the drug's identity should be verified by chemical analysis.
`
`PT
`
`
`
`http://www.thomsonhc.com/pdrel/librarian/CommandSync/032D08C0-CD29-131A-FD4B-B<«.. 10/9/02
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1021, Pg. 11 of 16
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1021, Pg. 11 of 16
`
`

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`PDR® Electronic Library(TM)- Print-Ready Document
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`Page 5 of 5
`
`Consumer.Care Division Te
`
`PotesPOT|
`eeties
`mein lemeui) ee
`crscectauneviar-aenpary
`
`B
`
` Bayer.Corporation.” ae
`
`
`
`
`Copyright © 2002 Thomson - Medical Economics at Montvale, NJ 07645. All rights reserved.
`
`http://www.thomsonhc.com/pdrel/librarian/CommandSync/032D08C0-CD29-131A-FD4B-Bé.,. 10/9/02
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1021, Pg. 12 of 16
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1021, Pg. 12 of 16
`
`

`

`ATTACHMENT3
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1021, Pg. 13 of 16
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1021, Pg. 13 of 16
`
`

`

`NAPROXEN SODIUMSoft Gelatin Capsules
`
`Active ingredient (in each softgel)
`Naproxen Sodium 220 mg (Naproxen 200 mg)
`
`Purpose
`Pain reliever/Fever Reducer
`
`Uses
`
`headache
`wm
`™ commoncold
`w Temporarily relieves minor aches and pains due to:
`
`Hm m@=muscular achestoothache
`
`
`m==backache ==menstrual cramps
`
`x
`minor pain ofarthritis
`
`m Temporarily reduces fever
`
`Warnings
`
`Allergy alert: Naproxen sodium may cause a severe allergic reaction which may include: m hives
`m facial swelling m=
`asthma (wheezing) m shock
`
`{f you consume 3 or more alcoholic drinks every day, ask your doctor whether
`Alcohol warning:
`you should take naproxen sodium or other pain relievers/fever reducers. Naproxen sodium may
`cause stomachbleeding.
`
`Do notuse if you have ever had an allergic reaction to any other pain reliever/fever reducer.
`
`Ask a doctor before use if you have had serious side effects from any pain reliever/fever reducer.
`
`Ask a doctor or pharmacist before use if you are:
`m taking any other product that contains naproxen sodium or any otherpain reliever/fever reducer
`Bm
`taking other drugs on a regular basis
`m=
`sounder a doctor's care for any continuing condition
`
`Stop use and ask a doctorif:
`anyallergic reaction occurs, Seek medical help right away
`any newor unexpected symptoms occur
`symptoms continue or worsen
`you have difficulty swallowing orit feels like the softgel is stuck in your throat
`you develop heartburn
`stomach pain occurs with use of this productorif even mild symptomspersist
`pain worsens or lasts for more than 10 days
`fever lasts for more than 3 days
`painful area is red or swollen
`
`It is especially important not to
`If pregnant or breast-feeding, ask a health professional before use.
`use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a
`doctor because it may cause problems in the unborn child or complications during delivery.
`
`Keep out of reach of children.
`Center right away.
`
`In case of overdose, get medical help or contact a Poison Control
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1021, Pg. 14 of 16
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1021, Pg. 14 of 16
`
`

`

`Directions
`
`@ Drink a full glass of water with each dose
`Do not take more than directed
`Age 65 and older:
`1 softgel every 12 hours. Do not exceed 1 softgel in 12 hours, unless
`directed by a doctor.
`1 softgel every 8 to 12 hours. Forthe first dose you may take 2 softgels
`12-65 years of age:
`within the first hour. Do not take more than 2 softgels in a 8 to 12 hour, or 3 softgels ina 24
`hour period.
`,
`Under 12 years of age: Ask a doctor.
`
`Other information
`Each softgel contains: sodium 20 mg
`Store between 20-25°C (68-77°F)
`Avoid high humidity and excessive heat (40°C (104°F)]
`See side panel for Jot number and expiration date.
`Do notuse if carton or blister unit is open or torn.
`
`Inactive ingredients
`To be determined
`
`Questions or comments?
`To be determined
`
`Distributed by
`To be determined
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1021, Pg. 15 of 16
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1021, Pg. 15 of 16
`
`

`

`FROM:
`
`SERV:CE
`
`
`
`TRKH:709934000016324008
`
`10/30/02
`11:46
`
`FDA#OFPCS:|
`
`
`
`TO:HFA~305/RH1061
`
`8303024237647
`
`RM
`
`HFA-305/ RM 1061
`
`ECTANN
`
`DepartmentofHeaithandHumanServices
`
`
`
`
`
`5630FishersLane
`
`Room1061
`
`
`
`
`
`Rockville,Maryland20852
`
`
`
`FoodandDrugAdministration
`
`
`
`DocketsManagementBranch(HFA-305)
`
`
`
`
`
`
`
`HicuPoint,NorTHCAROLINA27261-22104£
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`POBox2210,4125PremierDrivex
`
`
`
`
`
`
`
`HA705353400OO1b32400893
`
`PHARMACAPS
`
`®BANNER
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1021, Pg. 16 of 16
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1021, Pg. 16 of 16
`
`
`