CENTER FOR DRUG EVALUATION AND RESEARCH
`
`Approval Package for:
`
`APPLICA TION NUMBER:
`
`21-303
`
`Trade Name:
`
`Adderall XR Capsule
`
`Generic Name: mixed salt of a single entity amphetamine product
`
`Sponsor:
`
`Shire Laboratories, Inc.
`
`Approval Date: October 11, 2001
`
`Indications:
`
`Provides for the use of Adderall XR Capsule for the
`treatment of Attention Deficit Hyperactivity Disorder.
`
`Amerigen Ex. 1066, p. 1
`Amerigen Ex. 1066, p.
`1
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`

`
`CENTER FOR DRUG EVALUATION AND
`
`RESEARCH
`
`APPLICA TION NUMBER:
`
`2 1 -3 03
`
`APPROVAL LETTER
`
`Amerigen Ex. 1066, p. 2
`Amerigen Ex. 1066, p. 2
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`

`
`((1
`
`-/(C
`
`‘
`
`NDA 21303
`
`I
`
`DEPARTMENTOFHEALTH &HUMAN SERVICES
`
`Food and Drug Administration
`Rockville, MD 20357
`
`Shire Laboratories, Inc
`Attention: Tami Martin
`
`Vice President, Regulatory Affairs
`1550 East Gude Drive
`
`Rockville, MD 20850
`
`Dear Ms. Martin:
`
`Please refer toyour new drug application (NDA) dated October 3, 2000, received October 3, 2000,
`submitted under section 505(b) of the Federal Food, Drug, and Cosmetic" Act for Adderall XR (mixed
`salt of a single entity amphetamine product) Capsule.
`
`We acknowledge receipt of your submissions dated:
`
`August 13, 2001
`August 29, 2001
`October 3, 2001
`
`August 14, 2001
`September 25, 2001
`
`August 22, 2001
`October 2, 2001
`
`Your submission of August 14, 2001 constituted a complete response to our August 3, 2001 action
`letter.
`
`This new drug application provides for the use of Adderall XR (mixed salt of a single entity '
`amphetamine product) Capsule for the treatment of Attention Deficit Hyperactivity Disorder.
`
`We have completed the review of this application, as amended, and have concluded that adequate
`information has been presented to demonstrate that the dmg product is safe and effective for use as
`recommended in the agreed upon enclosed labeling text. Accordingly, the application is approved
`effective on the date of this letter.
`
`The final printed labeling (FPL) must be identical to the enclosed labeling (text for the package insert).
`Marketing the product with FPL that is not identical to the approved labeling text may render the
`product misbranded and an unapproved new-drug.
`
`Please submit the copies of final printed labeling (FPL) electronically according to the guidance for
`industry titled Providing Regulatory Submissions in Electronic Formot - NDA (January 1999).
`Alternatively, you may submit 20 paper copies of the FPL as soon as it is available but no more than 30
`days after it is printed. Please individually mount ten of the copies on heavy-weight paper or similar
`material. For administrative purposes, this submission should be designated "FPL for approved NDA
`21303." Approval of this submission by FDA is not required before the labeling is used.
`
`Amerigen Ex. 1066, p. 3
`Amerigen Ex. 1066, p. 3
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`

`
`NDA 21-303
`
`Page 2
`
`' Validation of the regulatory methods has not been completed. At the present time, it is the policy of
`the Center not to withhold approval because the methods are being validated. Nevertheless, we expect
`your continued cooperation to resolve any problems that may be identified.
`
`Be advised that, as of April 1, 1999, all applications for new active ingredients, new dosage forms,-new
`indications, new routes of administration, and new dosing regimens are required to contain an
`‘assessment of the safety and effectiveness of the product in pediatric patients unless this requirement is
`waived or deferred (63 FR 66632). We note that you have not fiilfilled the requirements of 21 CFR
`314.55 (or 601.27). We are deferring submission of your pediatric studies for the under six years of
`age group. However, in the interim, please submit your pediatric drug development plans within 120
`days fi'om the date of this letter unless you believe a waiver is appropriate. Within approximately 120
`days of receipt of your pediatric drug development plan, we will review your plan and notify you of its
`- _adequacy.
`
`If you believe that this drug qualifies for a waiver of the pediatric study requirement, you should submit
`a-request for a waiver with supporting information and documentation in accordance with the
`provisions of 21 CFR 314.55 within 60 days from the date of this letter. We will notify you within 120
`days of receipt of your response whether a waiver is granted. If a waiver is not granted, we will ask
`you to submit your pediatric drug development plans within 120 days from the date of denial of the
`- waiver.
`
`Pediatric studies conducted under the terms of section 505A of the Federal Food, Drug, and Cosmetic
`Act may result in additional marketing exclusivity for certain products (pediatric exclusivity). You
`should refer to the Guidancefor Industry on Qualrjyingfor Pediatric Exclusivity (available on our web
`site at. www.fda.gow'cderfpediatric) for details. [fyou wish to qualify for pediatric exclusivity you
`should submit a "Proposed Pediatric Study Request" (PPSR) in addition to your plans for pediatric
`drug development described above. We recommend that you submit a Proposed Pediatric Study
`Request within 120 days from the ‘date of this letter. If you are unable to meet this time frame but are
`interested in pediatric exclusivity, please notify the division in writing. FDA generally will not accept
`studies submitted to an NDA before issuance of a Written Request as responsive to a Written Request.
`Sponsors should obtain a Written Request before submitting pediatric studies to an NDA. Ifyou do
`not submit a PPSR or indicate that you are interested in pediatric exclusivity, we will review your
`pediatric drug development plan and notify you of its adequacy. Please note that satisfaction of the
`requirements in 21 CFR 314.55 alone may not qualify you for pediatric exclusivity. FDA does not
`necessarily ask a sponsor to complete the same scope of studies to qualify for pediatric exclusivity as it
`does to fulfill the requirements of the pediatric rule.
`'
`'
`
`In addition, please submit three copies of the introductory promotional materials that you propose to
`use for this product. All proposed materials should be submitted in draft or mock—up form, not final
`print. Please submit one copy to this Division and two copies of both the promotional materials and
`the package insert directly to:
`
`Division of Drug Marketing, Advertising, and Communications, HFD-42
`Food and Drug Administration
`5600 Fishers Lane '
`
`Rockville, Maryland 20857
`
`Amerigen Ex. 1066, p. 4
`Amerigen Ex. 1066, p. 4
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`

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`NDA 21303
`
`Page 3
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`_ We remind you that you must comply with the requirements for an approved NDA set forth under
`21 GFR 314.80 and 314.81.
`
`As a Phase 4 commitment please submit a patient information package for our review.
`
`If you have any questions, call Ms. Anna Marie Homonnay, R.Ph., Regulatory Project Manager, at
`(301) S945535._
`'
`
`Sincerely,
`
`{See appem.-’cJ aim;-rron:'c s.ignu.'r.+rc» pr.-go}
`
`Russell Katz, MD.
`Director
`- Division of Neuropharmacological Drug Products
`Oflice of Drug Evaluation
`Center for Drug Evaluation and Research
`
`Enclosure
`
`Amerigen Ex. 1066, p. 5
`Amerigen Ex. 1066,
`5