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FDA News Briefs for Monday, November 26, 2018

November 26, 2018

These Food and Drug Administration (FDA) developments came in last week:


FDA Approves Daurismo for Treatment of AML

The FDA has approved Daurismo (glasdegib; Pfizer) to be used in combination with low-dose cytarabine for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults aged 75 years or older, or who have other chronic health conditions or comorbidities that may preclude the use of intensive chemotherapy.  More Information.


FDA Expands Approval for Venclexta

The FDA has approved Venclexta (venetoclax; AbbVie Inc. and Genentech Inc.) in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly-diagnosed AML in adults aged 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.  More Information.


FDA Safety Alert: Beckman Coulter Life Sciences Flow Cytometers

Beckman Coulter Life Sciences has notified FC 500 and EPICS Flow Cytometer customers of a potential intermittent or permanent failure of a component on the circuit amplifier boards. This issue has the potential to impact all assays run on the cytometers for any application, including laboratory-developed tests. This issue has been identified as a Class 1 recall. More Information.


Recall of Mylan Valsartan Products

Mylan has initiated a voluntary nationwide recall of select lots of valsartan-containing products, including 6 lots of amlodipine and valsartan tablets, 7 lots of valsartan tablets, and 2 lots of valsartan and hydrochlorothiazide tablets due to detected trace amounts of an impurity, N-nitrosodiethylamine. More Information.


Recall of Fresenius Kabi Sodium Chloride Injection

Fresenius Kabi USA is voluntarily recalling 163 lots of sodium chloride injection. The product insert states that stoppers for both the 10 mL and the 20 mL vials do not contain natural rubber latex; the tray label for the 2 vial sizes and the vial label for the 20 mL vial also state that the stoppers do not contain latex. The product is being recalled because the stoppers contain natural rubber latex.  More Information.