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FDA News Briefs for Friday, May 31, 2019

May 31, 2019

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


FDA Expands Approval of Revlimid

The FDA has granted expanded approval for Revlimid (lenalidomide; Celgene Corporation) to be used in combination with a rituximab product for previously treated follicular lymphoma and previously treated marginal zone lymphoma. Revlimid is a thalidomide analogue and was previously approved for multiple myeloma, relapsed or progressed mantle cell lymphoma, and transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes. More Information.  


FDA Expands Approval for Vraylar

The FDA has granted expanded approval for Vraylar (cariprazine; Allergan) for the treatment of depressive episodes associated with bipolar I disorder in adult patients. Vraylar is an atypical antipsychotic and was previously approved for use in adult patients with schizophrenia and acute manic or mixed episodes associated with bipolar I disorder. More Information.


Amikacin Sulfate and Prochlorperazine Edisylate Injections Recalled

Heritage Pharmaceuticals Inc. issued a voluntary recall of amikacin sulfate injection 1 g/4 mL and prochlorperazine edisylate injection 10 mg/2 mL due to microbial growth detection in 1 unreleased sublot of each medication. Use of these products could potentially result in site-specific or systemic infection. More Information.