November 7, 2025
Drug Approvals
Kygevvi® (doxecitine/doxribtimine) – New orphan drug approval
November 3, 2025 - UCB announced the FDA approval of Kygevvi (doxecitine/doxribtimine), for the treatment of thymidine kinase 2 deficiency (TK2d) in adults and pediatric patients with an age of symptom onset on or before 12 years.
Drug Recalls - Availability
Grifols – Withdrawal of Gamunex®-C (immune globulin [human]) 10% injection
October 28, 2025 - Grifols Therapeutics announced a voluntary, consumer level withdrawal of four lots of Gamunex-C (immune globulin [human]) 10% injection because of an increased rate of allergic/hypersensitivity type reactions.
Drug Recalls - Availability
Otsuka ICU Medical – Recall of potassium chloride injection
October 29, 2025 - Otsuka ICU Medical announced a voluntary, consumer-level recall of one lot of potassium chloride injection 20 mEq because the OVERWRAP label incorrectly identifies the product as potassium chloride injection 10 mEq.
New Generics
Dalvance® (dalbavancin) – First-time generic
October 29, 2025 - Teva launched an AP-rated generic version of AbbVie’s Dalvance (dalbavancin) injection.