Insulin aspart (Novolog - Novo Nordisk) is the second rapid-acting insulin analog to be approved by the FDA. The first was insulin lispro (Humalog). Insulin aspart differs from human insulin by substitution of aspartic acid for proline in position 28 on the beta-chain.

The FDA has approved a fixed-dose extended-release formulation of oxycodone and acetaminophen (Xartemis XR – Mallinckrodt) for oral treatment of acute pain severe enough to require an opioid. Oxycodone is available in the US as a single entity in oral immediate-release (Oxecta, and others) and extendedrelease (OxyContin) formulations. Immediate-release oxycodone is also available in combination with aspirin (Percodan, and others), acetaminophen (Percocet, and others), or ibuprofen (see Table 1).

The FDA has approved a new 2.5-mg formulation of the direct factor Xa inhibitor rivaroxaban (Xarelto – Janssen) for use in combination with low-dose aspirin to reduce the risk of major cardiovascular events in patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD). Rivaroxaban is the first direct oral anticoagulant to be approved for this indication. It was approved earlier for prevention and treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE) and for prevention of stroke and systemic embolism in patients with nonvalvular atrial...

The FDA has approved the GABA_A receptor modulator brexanolone (Zulresso – Sage Therapeutics) for IV treatment of postpartum depression (PPD). Brexanolone is the first drug to be approved by the FDA for this indication.

The FDA has approved the intravenously administered beta₁-adrenergic blocker landiolol (Rapiblyk – AOP) for short-term reduction of ventricular rate in adults with supraventricular tachycardia including atrial fibrillation and atrial flutter. Esmolol (Brevibloc, and generics), another IV beta blocker, was approved earlier for the same indication.

The progestin levonorgestrel is available over the counter for emergency contraception as two 0.75-mg tablets taken 12 hours apart (generic formulations of Plan B) and as a single 1.5-mg tablet taken once (Plan B One-Step, and generics). A third emergency contraceptive, ulipristal (Ella – Watson), is available with a prescription.1 It appears that, pursuant to a court order, Plan B One-Step (but not the generic products), which was previously available over the counter from a pharmacist only for women 17 years and older, will now be available directly from pharmacy shelves with no age...

A liposomal formulation of irinotecan (Onivyde – Merrimack) has been approved by the FDA for use in combination with fluorouracil and leucovorin for treatment of metastatic pancreatic cancer that has progressed after gemcitabine-based therapy. A non-liposomal formulation of irinotecan (Camptosar, and generics) has been available in the US for many years. The liposomal carrier prolongs exposure to irinotecan and improves the cellular uptake and cytotoxic effect of the drug.1FDA approval of liposomal irinotecan was based on the results of an open-label trial (NAPOLI-1) in 417 patients with...

The FDA has approved Lonsurf (Taiho Oncology), a combination of the thymidine-based nucleoside analog trifluridine and the thymidine phosphorylase inhibitor tipiracil, for oral treatment of metastatic colorectal cancer. Trifluridine is incorporated into DNA, interfering with DNA synthesis and inhibiting cell proliferation. Tipiracil inhibits the metabolism of trifluridine. The combination is only approved for use in patients who were previously treated with a fluoropyrimidine (fluorouracil or capecitabine), oxaliplatin, irinotecan, an anti-VEGF biological such as bevacizumab, and, if the tumor...

The FDA has approved adjunctive treatment with Dartisla ODT (Edenbridge), a new orally disintegrating tablet (ODT) formulation of the anticholinergic drug glycopyrrolate, to reduce symptoms of a peptic ulcer. Glycopyrrolate oral tablets (Robinul, Robinul Forte, and generics) were approved for the same indication in 1961.

The FDA is requiring a boxed warning in the label of denosumab (Prolia – Amgen), a monoclonal antibody that inhibits osteoclasts, about an increased risk of severe hypocalcemia in patients with advanced chronic kidney disease (CKD; eGFR <30 mL/min/1.73 m²), particularly those on dialysis. FDA-approved indications for Prolia are listed in Table 1.