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5/12/2023

Valganciclovir Oral Presentations

Products Affected - Description

    • Valcyte oral powder for solution, Genentech, 50 mg/mL, 100 mL glass bottle, NDC 00004-0039-09
    • Valcyte oral tablet, Genentech, 450 mg, bottle, 60 count, NDC 00004-0038-86
    • Valganciclovir hydrochloride oral tablet, Camber, 450 mg, bottle, 60 count, NDC 31722-0832-60
    • Valganciclovir hydrochloride oral tablet, Cipla USA, 450 mg, bottle, 60 count, NDC 69097-0277-03 - discontinued
    • Valganciclovir hydrochloride oral tablet, Major, 450 mg, unit-dose blister pack, 20 count, NDC 00904-6796-10
    • Valganciclovir hydrochloride oral tablet, Major, 450 mg, unit-dose blister pack, 30 count, NDC 00904-6796-04
    • Valganciclovir hydrochloride oral powder for solution, Teva, 50 mg/mL, 100 mL glass bottle, NDC 00591-2579-20

Reason for the Shortage

    • Ajanta was not available to provide information.
    • Camber did not provide a reason for the shortage.
    • Cipla discontinued valganciclovir tablets.
    • Dr. Reddy's was not available to provide information.
    • Genentech is transferring valganciclovir presentations to H2 Pharma.
    • Major has valganciclovir tablets available.
    • Somerset has valganciclovir powder for solution available.
    • Teva did not provide a reason for the shortage.

Available Products

    • Valganciclovir hydrochloride oral powder for solution, Somerset Therapeutics LLC, 50 mg/mL, 100 mL glass bottle, NDC 70069-0810-01

Estimated Resupply Dates

    • Camber has valganciclovir 450 mg tablets in 60 count bottles on back order and the company estimates a release date of mid-May 2023. They will be allocating product upon release.
    • Genentech has valganciclovir 450 mg tablets and 50 mg/mL oral solution available in limited quantities.
    • Major has valganciclovir 450 mg tablets in 20-count unit-dose packs and 30-count unit-dose packs on back order and the company cannot estimate a release date.
    • Teva has valganciclovir 50 mg/mL powder for solution in 100 mL bottles on back order and the company estimates a release date in late-June 2023.

Updated

Updated May 12, 2023 by Elyse MacDonald, PharmD, MS, BCPS. Created February 8, 2023 by Leslie Jensen, PharmD, Drug Information Specialist. © 2023, Drug Information Service, University of Utah, Salt Lake City, UT.

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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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