The FDA has approved Yosprala (Aralez), a fixed-dose combination of delayed-release aspirin and immediate-release omeprazole, for secondary prevention of cardiovascular and cerebrovascular events in patients who are at risk of developing aspirin-associated gastric ulcers (≥55 years old or history of gastric ulcers). Yosprala is the first product to become available in the US that combines aspirin and a proton pump inhibitor (PPI).

Cosibelimab (Unloxcyt – Checkpoint Therapeutics), a programmed death ligand-1 (PD-L1) blocking antibody, has been approved by the FDA for treatment of locally advanced or metastatic cutaneous squamous cell carcinoma in adults who are not candidates for curative surgery or radiation. It is the first PD-L1 inhibitor to be approved in the US for this indication. The PD-1 inhibitors pembrolizumab (Keytruda) and cemiplimab (Libtayo) are also approved for treatment of cutaneous squamous cell carcinoma.

Remestemcel-L (Ryoncil – Mesoblast), an allogeneic bone marrow-derived mesenchymal stromal cell therapy, has been approved by the FDA for treatment of steroid-refractory acute graft-versus-host disease (GVHD) in patients ≥2 months old. Steroid-refractory GVHD is associated with a poor prognosis, organ damage, and death, particularly in pediatric patients. Remestemcel-L is the first cellular therapy to be approved in the US for this indication and the only treatment of any kind to be approved for GVHD in children <12 years old.

Misoprostol (Cytotec - Searle), a synthetic methyl analog of prostaglandin E1, was recently approved by the US Food and Drug Administration for prevention of gastric ulcers in high-risk patients taking nonsteroidal anti-inflammatory drugs (NSAIDs). In other countries, the drug is also marketed for treatment of idiopathic peptic ulcers unrelated to NSAIDs.

Succimer (meso 2,3-dimercaptosuccinic acid; DMSA; CHEMET - McNeil), a heavy metal chelator, was recently marketed in the USA for oral treatment of lead poisoning in children.

FK 506 (Fujisawa), an immunosuppressant similar in activity to cyclosporine (Sandimmune - Medical Letter 25:77, 1983), is currently under investigation in the USA, Europe, and Japan for prevention of organ transplant rejection.

The enzyme alpha-galactosidase (Beano - AkPharma), derived from a mold and classified as a food, is sold without presecription in pharmacies and food stores. The manufacturer recommends taking the anzyme to decrease intestinal gas producted by eating the high-fiber diets now widely recommended in the USA.

In 1989, Photoplex (Allergan Herbert), a combination of the dibenzoyl methane avobenzone (Parsol 1789) and the aminobenzoic acid (PABA) ester padimate O, was the first 'broad spectrum' sunscreen to become available in the USA (Medical Letter, 31:59, 1989). Now, Shade UVAGuard (Schering-Plough), a similar product, has been approved by the US Food and Drug Administration; it also contains avobenzone, plus the benzophenone oxybenzone and octyl methoxycinnamate.

Strontium-89 chloride was recently approved for marketing by the US Food and Drug Administration. It is offered for relief of pain caused by metastatic bone lesions

Abciximab (ab sik si mab; ReoPro - Centocor), the Fab (fragment antigen binding) fragment of the chimeric human-murine monoclonal antibody 7E3 (c7E3 Fab), has been approved by the US Food and Drug Administration as an adjunct to percutaneous transluminal coronary angioplasty or atherectomy (PTCA) to prevent abrupt closure of the treated coronary vessel.