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Actualizaciones regulatorias

Novedades regulatorias de FDA, EMA, TGA y organismos globales

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UPDATED
Actualizaciones regulatorias
25 sept 2026•1 min de lectura
FDA Approves ANDA077947 for Fluconazole Injectable Products (Discontinued)
The FDA has approved ANDA077947 submitted by Baxter Healthcare Corp for two discontinued Fluconazole injectable products in 0.9% sodium chloride, strengths 200 mg/100 mL and 400 mg/200 mL.
UPDATED
Actualizaciones regulatorias
25 sept 2026•1 min de lectura
FDA Approves ANDA 088371 for Baxter Cyclophosphamide Injection
The FDA has approved ANDA 088371 for a cyclophosphamide injectable product (100 mg/vial) marketed by Baxter Healthcare, with multiple manufacturing and labeling submissions approved.
UPDATED
Actualizaciones regulatorias
24 sept 2026•1 min de lectura
Baxter Issues Urgent Correction for Likorall™ Ceiling-Mounted Patient Lift
Baxter Corp. has issued an urgent correction for its Likorall™ ceiling‑mounted patient lift due to potential motor shaft breakage and reduced safety system performance, which may cause the lift strap to descend faster than expected.
UPDATED
Actualizaciones regulatorias
24 sept 2026•1 min de lectura
Baxter Issues Urgent Correction for Likorall™ Ceiling-Mounted Patient Lift
Baxter Corp. alerts users of a potential motor shaft breakage and reduced safety system performance in Likorall™ ceiling lifts, which may cause straps to lower faster.
UPDATED
Actualizaciones regulatorias
19 sept 2026•1 min de lectura
FDA Approves Baxter Potassium Chloride in Dextrose & Sodium Chloride Injection (NDA018008)
The FDA has approved Baxter Healthcare's intravenous potassium chloride, dextrose and sodium chloride injection (NDA018008) across several dosage strengths.