Amneal Pharma Receives Approvals for Generic Drug Applications
03 Julho 2023 - 4:09PM
Dow Jones News
By Denny Jacob
Amneal Pharmaceuticals on Monday said it received abbreviated
new drug application approvals from the U.S. Food and Drug
Administration for some complex generic products.
The drug company said the approvals pertain to
Medroxyprogesterone acetate injectable suspension, a generic
version of Depo-Provera, and Dexmedetomidine Hydrochloride, a
generic version of Precedex injection. Others include Nelarabine
injection, Dapsone and Mometasone furoate nasal spray, generic
versions of Arranon Injection, Aczone, and Nasonex,
respectively.
The news came in tandem with Amneal's launch of an authorized
generic of Xyrem oral solution CIII in the United States. The
sodium oxybate oral solution is a central nervous system depressant
indicated for the treatment of cataplexy or excessive daytime
sleepiness in patients seven years and older with narcolepsy.
"By adding these new medicines to our portfolio, Amneal is on
track to launch more than 30 new generics products this year," said
Chirag and Chintu Patel, co-chief executive officers.
Write to Denny Jacob at denny.jacob@wsj.com
(END) Dow Jones Newswires
July 03, 2023 14:54 ET (18:54 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.
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