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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: acetylcysteine effervescent tablets for oral solution
Trade Name: Cetylev
Date Designated: 02/24/2015
Orphan Designation: Preventing hepatic injury from acetaminophin overdose
Orphan Designation Status: Designated/Approved
Arbor Pharmaceuticals, Inc.
6 Concourse Parkway
Suite 1800
Atlanta, Georgia 30328
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: acetylcysteine effervescent tablets for oral solution
Trade Name: Cetylev
Marketing Approval Date: 01/29/2016
Approved Labeled Indication: Indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in patients with acute ingestion or from repeated supratherapeutic ingestion
Exclusivity End Date: N/A  
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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