`
`Public Health Service
`
`
`
`Food and Drug Administration
`Rockville, MD 20857
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`
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`NDA 21-450
`
`Judy W. Firor
`US Regulatory Affairs
`AstraZeneca Pharmaceuticals LP
`1800 Concord Pike
`PO Box 8355
`Wilmington, DE 19850-8355
`
`Dear Ms. Firor:
`
`Please refer to your new drug application (NDA) dated March 27, 2003, received March 28, 2003,
`submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Zomig (zolmitriptan)
`Nasal Spray.
`
`We acknowledge receipt of your submissions dated April 17, April 25, August 29, and September 30,
`2003 .
`
`The March 27, 2003 submission constituted a complete response to our December 19, 2002 action
`letter.
`
`This new drug application provides for the use of Zomig (zolmitriptan) Nasal Spray for the acute
`treatment of migraine.
`
`We completed our review of this application, as amended. It is approved, effective on the date of this
`letter, for use as recommended in the agreed-upon labeling text.
`
`The final printed labeling (FPL) must be identical to the enclosed labeling (text for the package insert,
`text for the patient package insert, immediate container and carton labels). 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 an electronic version of the FPL according to the guidance for industry titled Providing
`Regulatory Submissions in Electronic Format - NDA. 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. Individually mount 15
`of the copies on heavy-weight paper or similar material. For administrative purposes, designate this
`submission “FPL for approved NDA 21-450.” Approval of this submission by FDA is not required
`before the labeling is used.
`
`We acknowledge your phase 4 commitment, as discussed in a teleconference held on August 28, 2003
`and in your letter dated August 29, 2003, to provide the following information to support approval of
`(b)(4)----------------------- --- ------------ spray devices.
`-
`
`
`
`NDA 21-450
`Page 2
`
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`1. The results of an open-label, randomized, two-period crossover bioequivalence study
`comparing two single 5 mg doses of zolmitriptan (ZOMIG(cid:210) ) administered to healthy
`volunteers in the two nasal spray devices used in the clinical development program. The study
`will assess the bioequivalence of the two devices after single dose administration of
`zolmitriptan to healthy volunteers with particular regard to AUC, Cmax, and tmax. You commit
`to submit the results of this trial within 6 months of the date of this letter.
`
`
`
`2. Additional data in support of the(b)(4)-------------------------(details to be subsequently agreed to
`with the FDA) and to submit the-------------------------------he submission of the 5 mg
`bioequivalence study.
`
`
`In addition, submit three copies of the introductory promotional materials that you propose to use for
`this product. Submit all proposed materials in draft or mock-up form, not final print. Send one copy to
`this division and two copies of both the promotional materials and the package insert(s) directly to:
`
`
`
`
`
`Division of Drug Marketing, Advertising,
`and Communications, HFD-42
`Food and Drug Administration
`5600 Fishers Lane
`Rockville, MD 20857
`
`
`
`
`
`
`Please submit one market package of the drug product when it is available.
`
`We remind you that you must comply with reporting requirements for an approved NDA (21 CFR
`314.80 and 314.81).
`
`The MedWatch-to-Manufacturer Program provides manufacturers with copies of serious adverse event
`reports that are received directly by the FDA. New molecular entities and important new biologics
`qualify for inclusion for three years after approval. Your firm is eligible to receive copies of reports for
`this product. To participate in the program, please see the enrollment instructions and program
`description details at www.fda.gov/medwatch/report/mmp.htm.
`
`If you have any questions, call Lana Chen, Regulatory Project Manager, at (301) 594-5529.
`
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`Sincerely,
`
`{See appended electronic signature page}
`
`Russell Katz, M.D.
`Director
`Division of Neuropharmacological Drug Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
`
`
`
`Enclosure
`
`
`
`---------------------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`---------------------------------------------------------------------------------------------------------------------
` /s/
`---------------------
`Russell Katz
`9/30/03 12:40:35 PM
`
`