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FDA News Briefs for Wednesday, August 1, 2018

August 1, 2018

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


FDA Approves First Drug for Rare Adrenal Gland Tumors

On Monday, the FDA approved Azedra (iobenguane I 131; Progenics Pharmaceuticals Inc.), a radioactive therapeutic agent indicated for the treatment of adult and pediatric patients aged 12 years and older with iobenguane scan positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy. More Information.


FDA Approves Drug for Thrombocytopenia in Adults with Chronic Liver Disease

On Tuesday, the FDA approved Mulpleta (lusutrombopag; Shionogi Inc.), an oral thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure. More Information.


FDA Approves Once-Monthly Subcutaneous Risperidone Product

The FDA has approved Perseris (risperidone; Indivior PLC), a once-monthly atypical antipsychotic for the treatment of schizophrenia in adults. Perseris is administered by subcutaneous injection. More Information.


FDA Issues Warning on Vaginal Cosmetic Procedures

On Monday, the FDA warned against device manufacturers marketing energy-based medical devices for cosmetic vaginal procedures, also known as “rejuvenation”. The agency notes that these devices have not been approved or cleared to treat symptoms of menopause, urinary incontinence, or sexual function. More Information.