`RESEARCH
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`APPLICATION NUMBER:
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`205703Orig1s000
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`SUMMARY REVIEW
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`DIVISION OF CARDIOVASCULAR & RENAL PRODUCTS
`Divisional Memo
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`NDA:
`205703 Esmolol
`Sponsor:
`HQ Specialty Pharma
`Review date: 7 April 2016
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`Reviewer:
`N. Stockbridge, M.D., Ph.D., HFD-110
`Distribution: NDA 205703
`This memo conveys the Division’s recommendation to issue an Approval letter for this
`application.
`This 505(b)(2) application received a tentative Approval on 14 April 2014, pending
`expiration of patent protection by the innovator product.
`Labeling now reflects current practice.
`There was then and are now no post-marketing requirements or commitments.
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`M:\Docs-backup\NDA\N205703 Esmolol\EsmololDivMemo2.doc
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`Last saved
`16:07 Thursday, April 07, 2016
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`Reference ID: 3914173
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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.
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`/s/
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`NORMAN L STOCKBRIDGE
`04/07/2016
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`Reference ID: 3914173
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`DIVISION OF CARDIOVASCULAR & RENAL PRODUCTS
`Divisional Memo
`
`NDA:
`205703 Esmolol
`Sponsor:
`HQ Specialty Pharma
`Review date: 12 April 2014
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`Reviewer:
`N. Stockbridge, M.D., Ph.D., HFD-110
`Distribution: NDA 205703
`This memo conveys the Division’s recommendation to issue a Tentative Approval letter for
`this application.
`This application has been the subject of reviews of CMC (Chu; 26 February 2014),
`microbiology (Miller; 26 February 2014), pharmacology/toxicology (Gatti; 3 September
`2013), and biopharmaceutics (Houda; 20 March 2014)). There is a comprehensive CDTL
`memo (Srinivasachar; 4 April 2014) with which I am in full agreement. I highlight a few
`matters here.
`This is a 505(b)(2) application by virtue of a formulation difference with the reference listed
`drug .
`There are no CMC issues. Facility inspections are complete. The product will have a shelf-
`life of 18 months for the 2500-mg/250-mL formulation and 24 months for the 2000-
`mg/100-mL formulation.
`Because of a pending patent infringement suit, the action will be a tentative approval.
`There are no post-marketing commitments or requirements.
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`D:\DTS\Documentum\CTS\docbases\cdsadap2\config\temp_sessions\7338056876642662934\
`EsmololDivMemo.doc
`Last saved
`10:08 Saturday, April 12, 2014
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`1
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`Reference ID: 3488710
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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/
`----------------------------------------------------
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`NORMAN L STOCKBRIDGE
`04/12/2014
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`Reference ID: 3488710
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