Cibacalcin

NDA 18470, held by Novartis. Calcitonin Human.

As of Nov 13, 2026, NDA 18470 (Cibacalcin), held by Novartis, was first approved by FDA on Oct 31, 1986, with 4 approved supplements and 0 published complete response letters.

First approved: Oct 31, 1986
Review: Priority
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Oct 31, 1986	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Cibacalcin0.5MG/VIAL · injectable;injection	Calcitonin Human	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Nov 17, 1997	Supplement 5Labeling	Approved	None posted
Dec 18, 1995	Supplement 8Labeling · Standard review	Approved	None posted
Mar 6, 1989	Supplement 4Labeling	Approved	None posted
Jun 29, 1987	Supplement 1Labeling	Approved	None posted
Oct 31, 1986	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 18470
Drugs@FDA: Overview at FDA
Company: Novartis Pharmaceuticals Corporation

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters