ANI Pharmaceuticals Gets FDA Approval for ANDA for Rifabutin Capsules
21 December 2021 - 11:40PM
Dow Jones News
By Chris Wack
ANI Pharmaceuticals Inc. said it has received Food and Drug
Administration approval for the abbreviated new-drug application
for rifabutin capsules USP, 150 mg.
The company said its rifabutin capsules are the generic version
of the reference listed drug Mycobutin.
The current annual U.S. market for rifabutin capsules USP, 150
mg is about $16.6 million, according to IQVIA/IMS Health.
ANI Pharma said it plans to launch rifabutin capsules
immediately.
ANI Pharma shares were up 7% to $50 in premarket trading.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
December 21, 2021 07:25 ET (12:25 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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