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`Public Health Service
`
`Food and Drug Administration
`Rockville MD 20857
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`NDA 19-386/S-024
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`Baxter Healthcare Corporation, Anesthesia & Critical Care
`Attention: Lidia D. Mostovy
`Associate Director, Regulatory Affairs
`95 Spring Street
`New Providence, NJ 07974
`
`Dear Ms. Mostovy :
`
`Please refer to your supplemental new drug application dated April 25, 2003, received April 29, 2003,
`submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Brevibloc
`Concentrate (esmolol hydrochloride) 250 mg/mL in 10 mL ampuls.
`
`We also acknowledge receipt of your submission dated July 28, 2003.
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`This supplemental new drug application provides for reformulation of Brevibloc Concentrate with a
`reduced overage of the active ingredient (reduced from 10% to 2%).
`
`We have completed the review of this supplemental application as amended, and it is approved.
`
`We remind you that you must comply with the requirements for an approved NDA set forth under
`21 CFR 314.80 and 314.81.
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`If you have any questions, call Ms. Melissa Robb, Regulatory Health Project Manager, at (301)
`594-5313.
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`Sincerely,
`
`{See appended electronic signature page}
`
`Kasturi Srinivasachar, Ph.D.
`Chemistry Team Leader, DNDC I for the
`Division of Cardio-Renal Drug Products, (HFD-110)
`DNDC I, Office of New Drug Chemistry
`Center for Drug Evaluation and Research
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`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`---------------------------------------------------------------------------------------------------------------------
` /s/
`---------------------
`Kasturi Srinivasachar
`8/18/03 02:17:05 PM
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