FDA adds generic valganciclovir oral solution - Takeaways - MDSpire
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FDA adds generic valganciclovir oral solution

 The new option is indicated for CMV prophylaxis in pediatric kidney and heart transplant recipients, as well as adult CMV retinitis and transplant prophylaxis.

  • By

  • Mouj Hijazi

  • October 28, 2026

  • 2 min

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  • 1

    The FDA granted final ANDA approval to Alembic Pharmaceuticals for generic valganciclovir oral solution, 50 mg/mL.

  • 2

    The generic is therapeutically equivalent to Valcyte for Oral Solution, the reference-listed product held by CHEPLAPHARM Arzneimittel GmbH.

  • 3

    Valganciclovir is indicated to treat CMV retinitis in adults with AIDS and prevent CMV disease in high-risk kidney, heart, and kidney-pancreas transplant recipients.

  • 4

    The reference product labeling includes CMV prophylaxis for pediatric kidney transplant recipients aged 4 months to 16 years and heart transplant recipients aged 1 month to 16 years.

  • 5

    Valganciclovir carries boxed warnings for hematologic toxicity, impaired fertility, fetal toxicity, mutagenesis, and carcinogenesis; labeling recommends monitoring blood counts and renal function.

Original Source(s)

FDA adds generic valganciclovir oral solution

  • by Mouj Hijazi

  • October 28, 2026

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