Alamast

NDA 21079, held by Santen. Pemirolast Potassium.

As of Nov 14, 2026, NDA 21079 (Alamast), held by Santen, was first approved by FDA on Sep 24, 1999, with 7 approved supplements and 0 published complete response letters.

First approved: Sep 24, 1999
Review: Priority
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Sep 24, 1999	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Alamast0.1% · solution/drops;ophthalmic	Pemirolast Potassium	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Feb 15, 2013	Supplement 14Manufacturing · Priority review	Approved	None posted
May 12, 2005	Supplement 6Labeling · Standard review	Approved	Letter Label
May 12, 2005	Supplement 8Labeling · Standard review	Approved	Letter Label
May 3, 2002	Supplement 5Manufacturing · Priority review	Approved	None posted
Feb 20, 2002	Supplement 4Manufacturing · Priority review	Approved	None posted
Dec 12, 2000	Supplement 2Manufacturing · Priority review	Approved	None posted
May 26, 2000	Supplement 1Manufacturing · Priority review	Approved	None posted
Sep 24, 1999	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Identifiers

Application: NDA 21079
Drugs@FDA: Overview at FDA
Company: Santen, Inc.

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