Olopatadine 0.6% nasal spray (Patanase - Alcon) has been approved by the FDA for treatment of seasonal allergic rhinitis in patients ≥ 12 years old. An H1-antihistamine with mast-cell stabilizing activity, olopatadine is already marketed for treatment of allergic conjunctivitis in a 0.1% solution as Patanol and in a 0.2% solution as Pataday. Azelastine (Astelin), another H1-antihistamine with mast-cell stabilizing activity, has been available for intranasal treatment of allergic rhinitis since 1997.

The FDA has approved an intravenous (IV) formulation of acetaminophen (Ofirmev – Cadence) for use in patients ≥2 years old for management of pain either as monotherapy (mild to moderate pain) or with an opioid (moderate to severe pain) and for reduction of fever.

A reader has asked us to review the choice of drugs for heparin-induced thrombocytopenia (HIT), a prothrombotic state with high morbidity and mortality. Three recent publications have made somewhat different recommendations on its treatment.

The FDA has approved aclidinium bromide (Tudorza Pressair – Forest), an orally-inhaled long-acting anticholinergic, for long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD).

The FDA has recently approved intradetrusor injection of onabotulinumtoxinA (Botox – Allergan) for treatment of overactive bladder in patients who cannot tolerate or have an inadequate response to anticholinergic therapy. Botox is also approved by the FDA for use in detrusor overactivity associated with a neurologic condition such as multiple sclerosis or spinal cord injury, and for chronic migraine, upper limb spasticity, axillary hyperhidrosis, cervical dystonia, blepharospasm, strabismus, and cosmetic reduction of wrinkles.

The FDA has approved testosterone undecanoate (Aveed – Endo), an injectable depot formulation, for use in men with hypogonadism who require testosterone replacement therapy.

The FDA has approved sugammadex (Bridion – Merck), a selective relaxant binding agent, for reversal of rocuronium- or vecuronium-induced neuromuscular blockade in adult surgical patients. It is the first selective relaxant binding agent to be approved in the US. Sugammadex has been available in the European Union, Japan, and elsewhere for several years. Previous FDA reviews of sugammadex did not result in approval because of concerns about a risk of anaphylaxis and other hypersensitivity reactions with its use.

The FDA has approved the immune checkpoint inhibitor pembrolizumab (Keytruda – Merck), a programmed death receptor-1 (PD-1) inhibitor, for first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) that highly expresses programmed death-ligand 1 (PD-L1) and has no epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) translocations. About 25% of patients with advanced NSCLC have tumors with high levels of PD-L1 expression (PD-L1 expressed on ≥50% of tumor cells). Pembrolizumab was approved earlier for treatment...

The FDA has approved the selective alpha_1A-adrenergic receptor agonist oxymetazoline as a 1% cream (Rhofade – Allergan) for topical treatment of persistent facial erythema of rosacea in adults. Brimonidine, a selective alpha₂-adrenergic receptor agonist, was approved in 2013 as a 0.33% gel (Mirvaso) for the same indication. Like Mirvaso, Rhofade is not indicated for treatment of inflammatory lesions of rosacea. Oxymetazoline has been available over the counter for many years as a nasal decongestant spray (Afrin, and others).

The FDA has approved the interleukin (IL)-23 blocker guselkumab (Tremfya – Janssen) for treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Guselkumab is the first selective IL-23 blocker to become available in the US.