`
`Approval Package for:
`
`APPLICA TI0N NUMBER:
`
`19-386/8012
`
`Trade Name: .
`
`BreVibloc 100 mg/ 10 ml Vial
`
`Generic Name: Esmolol Hydrochloride
`
`Sponsor:
`
`A
`
`Ohmeda Inc.
`
`Approval Date:
`
`January 13, 1994
`
`Indications:
`
`Short-Term control of heart rate in patients
`with abnormally fast heart rhythms such as
`artrial fibrillation, atrial flutter or sinus
`
`tachycardia.
`
`
`
`CENTER FOR DRUG EVALUATION AND
`
`RESEARCH
`
`APPLICA TIONNUMBER:
`
`19-386 Supplement 12
`
`CONTENTS
`
`Reviews / Information Included in this NDA Review.
`
`
`
`
`
`_-
`
`»_-
`
`___
`
`-.'."-I—_
`
`
`
`
`
`
`
`
`
`--——_
`
`
`
`
`
`CENTER FOR DRUG EVALUATION AND RESEARCH
`
`APPROVAL PACKAGE FOR:
`
`APPLICATION NUMBER
`
`' NDA 19-386/5-012
`
`Approval Letter(s)
`
`
`
`if -/C‘
`
`
`
`DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
`
`Food and Drug Administration
`.Rockville MD 20857
`
`INDA 19-386/8—012
`
`.
`
`'
`
`JAN l3 IQQA _
`
`Ohmeda lnc.
`
`Attention: Mr. Robert lT Outwater
`110 Allentown Road
`PO. Box 804
`
`Liberty Corner. NJ 0793840804
`
`Dear Mr. Outwater:
`
`We acknowledge receipt on December 13,' 1993 ol your December .,10’ 1993 supplemental new -
`drug application submitted under seCIion 505(b)(1) ol the Federal Food, Drug. and Cosmetic
`Act for Brevibloc (esmolol hydrochloride) injection.
`
`in
`The supplemental application provides for reinstating the originally. approved amber vial.
`addition to the clear -—.———-— so that" this product may be exported to other countries.
`where the clear————-——-— is not approved.
`(Supplement 11 provided for the clear —-*
`——--—«. as a "substitute" for the amber vial when it should have been and “alternative" to the
`amber vial.)
`
`‘
`
`' We have completed the review of this supplemental application and itis 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.
`
`Sincerely yours,
`W i/ (
`
`( ,
`
`Rob rt J. Wolters; PhD.
`_
`Supervisory Chemisit»
`Division olCardio-Renal Drug Products
`Olfice of Drug Eval-Uation l
`Center tor Drug Evaluation and Research
`
`
`
`Page 2'
`
`- NDA 19-386/8-012’
`
`Original NDA
`
`HFD-110
`HFD-110/CSO-
`HFD-BO/D-DIR
`HFD-1oo
`
`HFD-232 (with labeling)
`HFD‘730
`_
`,
`HFD~11o/ZMcDonald/1/12/94;1/1_2/94 3M ./,;, MT
`sb/1/12/94;1/13/94
`-«
`R/D: DC'unnlngham/1/13/94
`RWolters/1/13/Q'4
`
`Approval-Date: December 31. 1986
`
`APPROVAL
`
`
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