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5/26/2016

Phentolamine Mesylate for Injection

Products Affected - Description

    • Phentolamine Mesylate injection, West-Ward, 5 mg, vial, NDC 55390-0113-01

Reason for the Shortage

    • West-Ward received FDA approval for phentolamine injection in Fall 2015. http://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Phentolamine%20Mesylate%20Injection&st=c&tab=tabs-1.
    • West-Ward Pharmaceuticals' parent company, Hikma Pharmaceuticals, acquired phentolamine injection from Bedford in July 2014. West-Ward discontinued the Bedford phentolamine product in early-January 2015.
    • Novartis discontinued marketing the brand name product Regitine in the US in 2000.
    • Sandoz Canada temporarily provided phentolamine mesylate to the US market (NDC 00781-3028-95) from May 2012 to early 2013.

Available Products

    • Phentolamine Mesylate injection, West-Ward, 5 mg, vial, NDC 00143-9564-10

Estimated Resupply Dates

    • West-Ward launched phentolamine injection in early-November 2015 and product is available.

Updated

Updated May 26, 2016 by Leslie Jensen, PharmD, Drug Information Specialist. Created October 2, 2014 by Jane Chandramouli, PharmD, Drug Information Specialist. Copyright 2017, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized distributor. ASHP and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this Bulletin. Neither ASHP nor the University of Utah endorses or recommends the use of any particular drug. Any application of this information for any purpose shall be limited to personal, non-commercial use.

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