The FDA has approved osilodrostat (Isturisa – Recordati), a cortisol synthesis inhibitor, for oral treatment of adults with Cushing's disease when surgical resection of the pituitary adenoma is not an option or has not been curative. Osilodrostat is the first cortisol synthesis inhibitor to be approved in the US for this indication. Other oral steroidogenesis inhibitors such as ketoconazole and metyrapone have been used off-label for this indication for many years.

The FDA has approved Lybalvi (Alkermes), a fixed-dose combination of the second-generation antipsychotic olanzapine (Zyprexa, and generics) and samidorphan, a new opioid antagonist, for treatment of adults with schizophrenia or with manic or mixed episodes of bipolar I disorder. The addition of samidorphan is intended to mitigate the weight gain that occurs with olanzapine. This is the first FDA approval for samidorphan.

The FDA has approved Vtama (Dermavant), a 1% cream formulation of the aryl hydrocarbon receptor (AhR) agonist tapinarof, for treatment of adults with plaque psoriasis. It is the first AhR agonist to be approved by the FDA.

Acute toxic reactions to drugs of abuse continue to be important problems. Some patients may have mixed intoxications with complex combinations of signs and symptoms.

Glaucoma is a progressive optic neuropathy associated with increased intraocular pressure (IOP; normal range 8-22 mm Hg), which is the only disease-related factor that can be modified. Topical drugs that lower IOP are the first line of treatment for open-angle glaucoma.

The US Food and Drug Administration recently approved the marketing of goserelin acetate (Zoladex - ICI Pharma), an implant for palliative treatment of advanced prostate cancer. Goserelin acetate is a synthetic decapeptide luteinizing hormone-releasing hormone (LH-RH) analog similar to leuprolide (Lupron; Lupron Depot) (Medical Letter, 27:71, 1985).

Two portable instruments for monitoring prothrombin time have been approved by the US Food and Drug Administration (FDA). The Coumatrak (DuPont Pharma) and CoaguChek (Boehringer Mannheim Diagnostics) are marketed in the USA only for use by healthcare professionals. In Europe, however, the CoaguChek is also marketed for use by patients. A CoaguChek Plus portable system, which measures activated partial thromboplastin time (APTT) as well as prothrombin time, is also available in both Europe and the USA.

Ropivacaine (Naropin - Astra), like bupivacaine (Marcaine, and others), is a member of the mepivacaine (Carbocaine, and others) family of local anesthetics. Bupivacaine has been an effective long-acting local anesthetic, but with overdosage or inadvertent intravascular injection, it can cause severe cardiotoxicity, which may not be reversible. Ropivacaine is claimed to be less cardiotoxic. It has been approved by the FDA for local or regional block for surgery, obstetrical procedures and postoperative pain management.

The FDA has approved crizotinib (Xalkori – Pfizer), an oral tyrosine kinase inhibitor, for treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with the anaplastic lymphoma kinase (ALK) translocation, which is found in about 4-5% of lung cancers. A diagnostic test (Vysis ALK Break Apart FISH Probe Kit – Abbott Molecular) is available to detect translocations of the ALK gene in tumor samples; these translocations occur predominantly in nonsmokers with adenocarcinoma.

Fungal infections of the fingernails or toenails can persist for months or years despite topical and systemic antimicrobial therapy. The FDA has cleared several short-pulse laser systems for treatment of this mainly cosmetic disorder.