October 10, 2002
`
`BANNER
`PHARMACAPS
`9';
`"um
`
`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.
`
`m flea/7a
`
`-
`
`gfl
`
`@BAANLR Piiumacws is:
`CA.iroRMA
`
`PO Box 2210
`4l25 PREMim DRiVE
`Hicu Porw. NC 272filA22ll)
`Noni‘H CARoLWA
`CANADA
`MExIco
`
`PHONk
`336 El? H700
`NETHERLANDS
`
`Fax
`lNuiA
`
`116 Hi“) 571/
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1021, Pg. 1 of16
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1021, Pg. 1 of 16
`
`

`

`At this time, the undersigned is also requesting a waiver of the requirement to
`conduct pediatric studies in accordance with 21 CFR §314.55(c)(2). The basis
`for this request is 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 allow:; 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 ANDA suitability
`petitions ofthis 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 who have difficulty swallowing tablets or simply prefer the alternative.
`
`in support of this 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 same route of administration as that of
`the RLD, Aleve® (Naproxen Sodium, 220 mg) tablets. A copy of the most
`recent Orange Book listing of “Approved Drug Products with Therapeutic
`Equivalence Evaluations" is provided. (Attachment 1)
`
`(2) The proposed drug product will 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)
`
`<®BAVNER PIMRMACAPS INC
`CAUFORNSA
`
`4l25 PREMIER Dmvt
`P O Box 22l0
`Noam CAROLlN/t
`CANADA
`
`HIGH POINT, NC Z726l-22|0
`MExico
`
`336 8l2 8700
`PHONE
`NETHFRLANDS
`
`336 Bi: 5777
`FAX
`INDlA
`
`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 which the petition
`relies, and that
`it
`includes representative data and information known to the
`petitioner, which are unfavorable to the petition.
`
`Respectfully submitted by:
`
`Wit»!
`
`Donna Lee, R.Ph.
`Director of Regulatory Affairs and Project Management
`Phone: (800) 447—1140 ext. 3312
`
`(3) Attachments
`
`3;:
`
`@BANNER pHARMACAFS im:
`CALiFDKNiA
`
`“25 PREMIER DMVE Hicu Pomr. NC 2726I~2210
`P O Box 22|0
`NomH CAROLINA
`CANADA
`MExaco
`
`336 812 5700
`PHONE
`NETHERXANDS
`
`FAX
`‘NDEA
`
`33¢ BIZ 5777
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1021, Pg. 3 of 16
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1021, Pg. 3 of 16
`
`

`

`ATTACHMENT 1
`
`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 ofl
`
`Active Ingredient Search Results from "OTC" table for query on "naproxen."
`
`
`
`Appl
`
`075168
`M
`
`074646
`”“—
`
`Active
`
`Ingredient
`
`Proprietary
`Name
`
`
`
`BAYER
`
`NAPROXEN SODIUM
`
`NAPROXEN
`EQ 200MG
`Tablet; Ora;
`
`BASE
`SODIUM
`
`DR REDDYS
`LABS lNC
`
`NAPROXEN SODIUM
`
`Tablet; Oral
`
`EQ 200MG
`BASE
`
`NAPROXEN
`SODIUM
`
`INVAMED
`
`NAPROXEN
`SODIUM
`NAPROXEN
`SODIUM
`NAPROXEN
`SODIUM
`
`LEINER
`
`PERRIGO
`PVT FORM
`,
`
` I
`
`
`
`Strength
`{ELI—D
`
`
` Applicant
`
`“BASE
`IM” H
`N
`Tablet; Oral EQ ZOOMG
`020204 Yes NAPROXEN SODIUM
`][ALEVE
`I III
`II?
`A
`
`NAPROXEN SODIUM
`
`074635
`“ ‘ "
`074551 No NAPROXEN SODIUM
`_._..___
`074739
`NAPROXEN SODIUM
`‘_ “
`
`021075 Yes NAPROXEN SODIUM;
`PSEUDOEPHEDRINE
`HYDROCHLORIDE
`
`Tablet; Oral
`
`AITablet; Oral
`Tablet; Oral
`
`EQ ZOOMG
`BASE
`EQ ZOOMG
`BASE
`EQ 200MG
`BASE
`
`Tablet,
`Extended
`Release;
`Oral
`
`ALEVE COLD
`EQ ZOOMG
`BASE;120MG AND SINUS
`
`BAYER
`
`Thank you for searching the Electronic Orange Book
`
`Return to Electronic Oragge 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!
`
`Eotumfifilectronio QraflgLBooLklomc Bag;
`
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/tempaidet.ofm?Appl_No—~=O20204&TABL.. 10/8/02
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1021, Pg. 6 of 16
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1021, Pg. 6 of 16
`
`

`

`ATTACHMENT 2
`
`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
`
`PDR for Nonprescription Drugs® and Dietary SupplementsTM 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) ................. Pain reliever/Fever reducer
`
`Uses: Temporarily relieves minor aches and pains due to:
`
`common cold
`headache
`toothache
`muscular aches
`backache
`
`menstrual cramps
`minor pain of arthritis
`
`temporarily reduces fever
`
`Warnings: Allergy Alert: Naproxen sodium may cause a severe allergic reaction which may include:
`
`- hives
`
`facial swelling
`.
`. asthma (wheezing)
`. shock
`
`If you consume 3 or more alcoholic drinks every day, ask your doctor whether you s
`Alcohol warning:
`take naproxen sodium or other pain relievers/fever reducers. Naproxen sodium may cause stomach bleed
`
`Do not use ifyou 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
`
`taking any other product that contains naproxen sodium or any other pain reliever/fever reducer
`0
`taking other drugs on a regular basis
`-
`- under a doctor's care for any continuing condition
`
`Stop use and ask a doctor if:
`
`http://www.thomsonhc.com/pdrel/librarian/CommandSync/O32D08CO—CD29-131A—FD4B-Bf... 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 symptoms occur
`symptoms continue or worsen
`you have difficulty swallowing or it feels like the pill is stuck in your throat
`you develop heartburn
`stomach pain occurs with use of this product or if even mild symptoms persist
`pain worsens or lasts 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 professional before use. It is especially important not to use
`naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor be
`it may cause problems in 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
`
`. do not take more than directed
`
`. drink a full glass of water with each dose
`
`ALEVE® Caplets
`
`
`
`Over age 65 l caplet every 12 hours. Do not exceed 1 caplet
`
`in 12 hours, unless directed by a doctor.
`
`1265 years
`take 1 caplet every 8 to 12 hours. For the first
`dose you may take 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.
`
`
`
`- ask a doctor
`
`
`under 12
`years
`
`.
`
`ALEVE® Gelcaps
`
`
`Over age 65 1 gelcap every 12 hours. Do not exceed 1 gelcap
`
`in 12 hours, unless directed by a doctor.
`
`,
`
`12—65 years
`
`
`
`
`take 1 gelcap every 8 to 12 hours. For the first
`dose you may take 2 gelcaps within the first
`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.
`
`
`
`
`' ask a doctor
`under 12
`years
`
`
`
`ALEVE® Tablets
`
`http://www.thomsonhc.com/pdrel/librarian/CommandSync/032DO8CO-CD29'131A-FD4B—B5... 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
`take 1 tablet every 8 to 12 hours. For the first
`
`. dose 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
`- ask a doctor
`
`years
`
`Other Information:
`
`. store at 20~25°C (68~77°F)
`- avoid high humidity and excessive heat 40°C (104°F)
`
`ALEVE® Caplets
`
`- each caplet contains: sodium 20 mg
`
`ALEVE® Gelcaps
`
`. each gelcap contains: sodium 20 mg
`
`ALEVE® Tablets
`
`o 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-l—4215, povidone, talc.
`
`* capsule-shaped tablet(s)
`** gelatin coated capsule~shaped tablet(s)
`
`How Supplied:
`
`ALEVE® Caplets in boxes of 8, 24, 50, 100, 150, 200.
`
`ALEVE® Gelcaps in boxes of20, 40, 80.
`
`ALEVE® Tablets in boxes of 24, 50, 100, 150.
`
`http ://www.thomsonhc.com/pdrel/librarian/CommandSync/03 2D08C0-CD29- l 3 lA—FD4B -Bf... 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
`
`Do not use ifcarton is open or if foil seal imprinted with "Safety SQUEASE ®" on bottle opening is miss
`or broken.
`
`Distributed by
`
`Bayer Corporation.
`
`PO Box 1910
`
`Morristown, NJ 07962—1 910 USA
`
`B-R LLC
`
`Rea’a' 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 made to assure accurate reproduction:
`please remember that any visual identification should be considered preliminary. In cases of poisoning 01
`suspected overdosage, the drug's identity should be verified by chemical analysis.
`
`F—m‘fl
`
`
`
`
`
`
`http://www.thornsonhc.com/pdrel/librarian/CommandSync/032D08CO—CD29—l31A~FD4B~B5... 10/9/02
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1021, Pg. 11 of 16
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1021, Pg. 11 of 16
`
`

`

`PDR® Electronic Library(TM) — Print~Ready Document
`
`Page 5 of 5
`
`.,
`Bayer:Corporatlon
`ConsumerGare Division ’
`
`,.
`
`.
`
`‘
`
`AM. my STRONG '
`
`lEVE
`
`
`
`
`
`V urn-WM Ian!
`‘ Mat-am] hummu-
`
`' “Eamsr ”M .7 =.
`mm:2»:an mlmn‘n)
`
`
`
`Copyright © 2002 Thomson - Medical Economics at Montvale, NJ 07645. AH rights reserved.
`
`http://www.th0rnsonhc.c0m/pdrel/librarian/CommandSync/O32D08C0—CD29—131A-FD4B-Bf... 10/9/02
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1021, Pg. 12 of 16
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1021, Pg. 12 of 16
`
`

`

`ATTACHMENT 3
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1021, Pg. 13 of 16
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1021, Pg. 13 of 16
`
`

`

`NAPROXEN SODIUM Soft Gelatin Capsules
`
`Active ingredient (in each softgel)
`Naproxen Sodium 220 mg (Naproxen 200 mg)
`
`Purpose
`Pain reliever/Fever Reducer
`
`Uses
`
`I Temporarily relieves minor aches and pains due to:
`
`I common cold
`I
`toothache
`
`I headache
`I muscular aches
`
`I menstrual cramps
`backache
`I
`I minor pain of arthritis
`
`I Temporarily reduces fever
`
`Warnings
`
`Allergy alert: Naproxen sodium may cause a severe allergic reaction which may include: I hives
`I facial swelling I
`asthma (wheezing) I shock
`
`if 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 stomach bleeding.
`
`Do not use 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:
`I taking any other product that contains naproxen sodium or any other pain reliever/fever reducer
`I taking other drugs on a regular basis
`I
`under a doctor‘s care for any continuing condition
`
`Stop use and ask a doctor if:
`any allergic reaction occurs. Seek medical help right away
`any new or unexpected symptoms occur
`symptoms continue or worsen
`you have difficulty swallowing or it feels like the softgel is stuck in your throat
`you develop heartburn
`stomach pain occurs with use of this product or if even mild symptoms persist
`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
`
`I Drink a full glass of water with each dose
`I Do not take more than directed
`I Age 65 and oider:
`1 sottgei every 12 hours. Do not exceed 1 softgei in 12 hours, unless
`directed by a doctor.
`
`I
`
`1 sottgel every 8 to 12 hours. For the first dose you may take 2 softgeis
`12 —65 years of age:
`within the first hour. Do not take more than 2 softgels in a 8 to 12 hour, or 3 softgeis in a 24
`hour period.
`I Under 12 years of age: Ask a doctor.
`
`Other information
`
`I Each softgei contains: sodium 20 mg
`I
`Store between 20-25°C (GB-77°F)
`Avoid high humidity and excessive heat [40°C (104°F)]
`See side panel for lot number and expiration date.
`Do not use 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
`
`

`

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`Petitioner - Catalent Pharma Solutions
`Ex. 1021, Pg. 16 of16
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1021, Pg. 16 of 16
`
`
`