CENTER FOR DRUG EVALUATION AND RESEARCH
`
`Approval Package for:
`
`APPLICA TION NUMBER:
`
`NDA 18-701/S-046
`
`Name:
`
`Haldol Injection (IM)
`
`Generic Name: haloperidol decanoate
`
`Sponsor:
`
`A Ortho-McNeil Pharmaceutical, Inc.
`
`Approval Date: 04/17/2002
`
`Vanda Exhibit 2040 - Page 1
`
`Vanda Exhibit 2040 - Page 1
`
`

`
`CENTER FOR DRUG EVALUATION AND RESEARCH
`
`APPLICATION NUMBER:
`
`NDA 18-701/S-046
`
`CONTENTS '
`
`L A Reviews / Information Included in thiigeview
`
`
`%n rovable Letter
`
`Re _I resentative Labelin
`Medical Review s
`
`
`
`A roval Letter
`
`
`
`Chemismi Reviewgg
`EA/FONSI
`
`
`Pharmacolo Review s
`Statistical Review s
`
`
`
`
`
`
`
`Microbiolo Review s
`Clinical Pharmacolo 3 /Bio harmaceutics Revievis)
`Administrative and Corres ondenee Document(s)
`
`
`
`Vanda Exhibit 2040 - Page 2
`
`Vanda Exhibit 2040 - Page 2
`
`

`
`CENTER FOR DRUG EVALUATION AND RESEARCH
`
`A APPLICA TION NUMBER:
`
`NDA 18-701/S-046
`
`APPROVAL LETTER
`
`Vanda Exhibit 2040 - Page 3
`
`Vanda Exhibit 2040 - Page 3
`
`

`
`C
`
`DEPARTMENT OF HEALTH & HUMAN SERVICES
`I
`
`I
`
`Public Health Service
`Food and Drug Administration
`Rockville MD 20857
`
`NDA 15-921 /S-076
`
`_ NDA 15-922 / S-066
`NDA 15-923 / S-072
`
`NDA 18-701 / S-046
`
`The R.W. Johnson Pharmaceutical Research Institute
`Attention: Susie Merchant
`
`920 Route 202
`
`POB 300
`
`Raritan, NJ 08869-0602
`
`Dear Ms. Merchant:
`
`Please refer to your supplemental new drug applications dated December 6, 2001, received December
`10, 2001, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Haldol
`(haloperidol) Tablets, Concentrate, Injection, and Haldol (haloperidol) Decanoate Injection
`
`These "Changes Being Effected" supplemental new drug applications provide for labeling changes as
`requested in our letter of September 25, 2000, specifically modification of labeling text to more clearly
`state that these agents are indicated for the treatment of schizophrenia.
`
`Wehave completed the review of these supplemental applications and have concluded that adequate
`information has been presented to demonstrate that the drug product is safe and effective for use as
`recommended in the submitted final printed labeling (package insert submitted December 6, 2001).
`Accordingly, these supplemental applications are approved effective on the date of this letter.
`
`If a letter communicating important information about this drug product (i.e., a "Dear Health Care
`Professional" letter) is issued to physicians and others responsible for patient care, we request that you
`submit a copy of the letter to this NDA and a copy to the following address:
`
`‘ MEDWATCH, HF-2
`FDA
`
`5600 Fishers Lane
`
`Rockville, MD 20857
`
`We remind you that you must comply with the requirements for an approved NDA set forth under
`21 CFR 314.80 and 314.81.
`’
`
`Vanda Exhibit 2040 - Page 4
`
`Vanda Exhibit 2040 - Page 4
`
`

`
`NDA 15-921 /S-O76
`
`NDA 15-922 / S-066
`
`NDA 15-923 / S-O72
`NDA 18-701 /S-046
`
`Page 2
`
`If you have any questions, call Steven D. Hardeman, R.Ph., Senior Regulatory Project Manager, at
`(301) 594-5525.
`
`Sincerely,
`
`;’Sc—*c appended L1/e"c.'I/'<)/2/"C 5'ig/min/‘c /Jugc,’
`
`Russell Katz,
`Director
`
`Division ofNeuropha1macologica1 Drug Products
`Office of Drug Evaluation 1
`Center for Drug Evaluation and Research
`
`Vanda Exhibit 2040 - Page 5
`
`Vanda Exhibit 2040 - Page 5
`
`

`
`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`
`Russell Katz
`
`4/17/02 08:23:15 AM
`
`VandaExmbH2040-Page6
`
`Vanda Exhibit 2040 - Page 6
`
`

`
`CENTER FOR DRUG EVALUATION AND RESEARCH
`
`APPLICA TION NUMBER:
`
`NDA 18-701/S-046
`
`REPRESENTATIVE LABELING
`
`Vanda Exhibit 2040 - Page 7
`
`Vanda Exhibit 2040 - Page 7
`
`

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`Vanda Exhi
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`it 2040 - Page 9
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`Vanda Exhibit 2040 - Page 9
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`CENTER FOR DRUG EVALUATIONAND RESEARCH
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`APPLICA TION NUMBER:
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`NDAR 18-701/S-