The FDA has approved the recombinant chimeric anti-CD20 antibody ublituximab-xiiy (Briumvi – TG Therapeutics) for IV treatment of adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome (initial neurological episode), relapsing-remitting disease, and active secondary progressive MS (SPMS). Two other anti-CD20 antibodies, IV ocrelizumab (Ocrevus) and SC ofatumumab (Kesimpta), are also FDA-approved for these indications.

Seladelpar (Livdelzi – Gilead), a peroxisome proliferator-activated receptor (PPAR)-delta agonist, has received accelerated approval from the FDA for use in combination with ursodeoxycholic acid (ursodiol, UDCA; Urso Forte, and generics) for treatment of primary biliary cholangitis (PBC) in adults who had an inadequate response to UDCA and as monotherapy in those unable to tolerate UDCA. Accelerated approval was based on a reduction in alkaline phosphatase (ALP) levels. Seladelpar is the second PPAR agonist to be approved in the US for this indication; elafibranor (Iqirvo)...

Antiplatelet drugs are the drugs of choice for prevention and treatment of arterial thrombosis. Anticoagulants are the drugs of choice for prevention and treatment of venous thromboembolism and for prevention of cardioembolic events in patients with atrial fibrillation.

Gastroesophageal reflux disease (GERD) is the most common GI condition encountered in the outpatient setting; it affects about 20% of people in the US.

Irritable bowel syndrome (IBS) is a common disorder characterized by recurrent abdominal pain and altered bowel habits, often accompanied by bloating. IBS is classified by its predominant bowel symptom: constipation (IBS-C), diarrhea (IBS-D), mixed type (IBS-M), or unclassified (IBS-U). Since the exact cause of IBS is unknown, the goal of treatment is symptom control. Some over-the-counter (OTC) products and prescription drugs for IBS are listed in Tables 1-4. The safety of these drugs during pregnancy and lactation is described in Table 5 (online only).

The FDA has approved pegvisomant (Somavert Pfizer), a growth hormone receptor antagonist, for parenteral treatment of acromegaly in patients who are not candidates for or have had an inadequate response to surgery or other treatment. This review describes the disease of acromegaly and its standard treatment options. Also included are sections on the mechanism of action, pharmacokinetics, adverse effects, drug interactions, and the dosage and cost of pegvisomant. Results of clinical studies are discussed. The conclusion provides an overall assessment of the prospects for this new drug.

The FDA has approved pegaptanib sodium (Macugen - Pfizer/Eyetech) as an intravitreous injection for treatment of all subtypes of neovascular (wet) age-related macular degeneration (AMD). The only other approved treatment for this condition is photodynamic therapy with intravenous verteporfin (Visudyne), which is recommended only for patients with one subtype (predominantly classic) of neovascular AMD.

Several injectable products are available for soft tissue augmentation of wrinkles and folds. These fillers are often used in conjunction with botulinum toxin type A (Botox) injections.

The most effective drugs available for treatment of tobacco dependence are bupropion (Zyban, and others and varenicline (Chantix). The FDA recently ordered the manufacturers of both to add boxed warnings about the risk of psychiatric symptoms and suicide to their prescribing information (FDA Alert, 7/1/2009).

The FDA has approved indacaterol (in´´ da ka´ ter ol; Arcapta Neohaler – Novartis), an inhaled long-acting beta₂-agonist, for once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). Indacaterol is not approved for treatment of exacerbations of COPD or for treatment of asthma. It has been available in Europe as Onbrez Breezhaler since 2009.