CENTER FOR DRUG EVALUATION AND
RESEARCH

APPLICATION NUMBER:

2080190rig15000

SUMMARY REVIEW

 

DIVISION OF CARDIOVASCULAR AND RENAL PRODUCTS
Divisional Memo
NDA:

208019 Potassium chloride powder for oral solution.

Sponsor:

Pharma Research Software Solutions

Review date: 19 August 2015
Reviewer:

N. Stockbridge, M.D., Ph.D., HFD-110

This memo conveys the Division’s decision to approve this application.
This application has been the subject of reviews of CMC (Kambhampati; 25 June 2015),
biopharmaceutics (Zolnik; 24 June2015), microbiology (Pfeiler; 5 March 2015), clinical
pharmacology (Hinderling; 29 June and 3 August 2015), and pharmacology/toxicology
(Yang; 27 April 2015). This memo also serves as the CDTL memo.
(b) (4)
The applicant seeks to market a 20 mEq
orally
to treat hypokalemia. The approval pathway is 505(b)(2), relying for safety and
effectiveness upon literature and the Agency’s findings for other oral dosage forms.

There are no manufacturing issues and manufacturing facilities have been deemed
satisfactory.
There is no microbiology issue.
Potassium chloride is highly soluble and highly bioavailable (BCS Class 1). Because the
body adjusts rapidly to potassium load, the pharmacokinetics is usually assessed by
excretion; about 90% of which is renal. The solution has bioavailability similar to that of
tablets. Kinetics is linear and unaffected by food.
(b) (4)
(b) (4)
The formulation contains the
sucralose
20 mEq of
(b) (4)
potassium, which would result in daily intake of
at the highest
recommended dose. This is about the same as the CFSAN-approved acceptable daily
intake (ADI). Toxicological studies of sucralose demonstrate the first effect being weight
loss because of displacement of calories in the diet. The review team and I agree that
there is no safety concern here.

Labeling has been fully negotiated. There are no remaining approval issues.

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Reference ID: 3808428

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---------------------------------------------------NORMAN L STOCKBRIDGE
08/19/2015

Reference ID: 3808428