FDA News Briefs for Friday, March 9, 2018March 9, 2018
These Food and Drug Administration (FDA) developments came in this week:
FDA Expands Indications for Atypical Antipsychotic Drug
Latuda (lurasidone HCI; Sunovion Pharmaceuticals Inc.) is now indicated to treat pediatric patients 10 to 17 years of age with major depressive episodes associated with bipolar disorder. The FDA previously approved Latuda to treat adults with depressive episodes associated with bipolar depression and for the treatment of schizophrenia in patients ≥ 13 years of age. More Information.
FDA Approves New Tests for Blood Donor Screening
The FDA has granted Oxford Immunotec, Inc. approval for 2 blood donor screening tests: the Imugen Babesia microti Arrayed Fluorescent Immunoassay (AFIA), for the detection of antibodies to Babesia microti (B. microti) in human plasma samples, and the Imugen Babesia microti Nucleic Acid Test (NAT), for the detection of B. microti DNA in human whole blood samples. Both assays are intended to help reduce risk of transfusion-transmitted babesiosis. More Information.
FDA Approves Mechanical Heart Valve Small Enough for Use in Newborns
The FDA has expanded approval for the Masters Series Mechanical Heart Valve with Hemodynamic Plus (HP) Sewing Cuff (St. Jude Medical) to include a 15 mm size, which the agency says is the smallest mechanical heart valve approved in the world. The device may now be used to treat newborn babies with heart defects. The Master Series Heart Valve was first approved by the FDA in larger sizes in 1995. More Information.