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.

Regorafenib (Stivarga – Bayer), a multikinase inhibitor, has been approved by the FDA for treatment of patients with metastatic colorectal cancer previously treated with multiple other regimens specified in the labeling. It has also been approved for use in treatment-refractory, locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST).

The FDA has approved crofelemer (kroe fel’ e mer; Fulyzaq – Salix), a chloride channel inhibitor derived from the red sap of the South American plant Croton lechleri, for symptomatic relief of noninfectious diarrhea in patients with HIV taking antiretroviral drugs. It is the first drug approved for relief of antiretroviral-induced diarrhea and the first oral botanical drug approved by the FDA.

Bellafill (Suneva), a dermal filler approved earlier for correction of nasolabial folds, has now also been approved by the FDA for correction of moderate to severe, atrophic, distensible facial acne scars on the cheek in adults ≥21 years old. It is the only dermal filler approved in the US for correction of facial acne scars.

The programmed death receptor-1 (PD-1) blocking antibody pembrolizumab (Keytruda – Merck), which has been available in an IV formulation since 2014 for treatment of various malignancies, has now been approved in a subcutaneous formulation as Keytruda Qlex. Keytruda Qlex is the first immune checkpoint inhibitor to become available in the US that can be administered subcutaneously. It has been approved for 38 of the 41 solid tumor indications that Keytruda is approved for. Keytruda's patent exclusivity expires in 2028.

The FDA has approved esketamine (Spravato – Janssen), an N-methyl-D-aspartate (NMDA) receptor antagonist, for intranasal treatment (in conjunction with an oral antidepressant) of adults with treatment-resistant depression (TRD). This is the first FDA approval for esketamine, which is the S-enantiomer of the intravenous anesthetic ketamine (Ketalar, and generics). In recent years, IV ketamine has been increasingly used (off-label) for treatment of TRD.