규제 업데이트

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.

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.

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.

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.

The FDA has approved Baxter Healthcare's intravenous potassium chloride, dextrose and sodium chloride injection (NDA018008) across several dosage strengths.