Fenoldopam mesylte (Corlopam - Neurex), a peripheral dopamine-1 (DA₁) agonist, has been approved by the FDA for parenteral use in lowering blood pressure. The manufacturer claims that, unlike other parenteral antihypertensive agents, fenoldopam not only lowers blood pressure but also maintains or improves renal function.

The FDA has approved a nebulized suspension of the corticosteroid budesonide for maintenance treatment of persistent asthma in children one to eight years old.

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 rivaroxaban (Xarelto – Janssen), an oral direct factor Xa inhibitor, for prevention of deep vein thrombosis (DVT) in patients undergoing knee or hip replacement surgery.

The FDA has approved pomalidomide (Pomalyst – Celgene), an oral thalidomide analog, for treatment of patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide (Revlimid) and bortezomib (Velcade) and whose disease had progressed on or within 60 days of completion of the last therapy.

Belbuca (Endo), a buccal formulation of the partial opioid agonist buprenorphine, has been approved by the FDA for management of pain severe enough to require daily, around-the-clock, long-term opioid treatment. Buprenorphine is also available as a transdermal patch (Butrans) and in a parenteral formulation (Buprenex, and generics) for treatment of pain. A sublingual formulation of buprenorphine and buccal and sublingual formulations containing buprenorphine and the opioid antagonist naloxone are approved for use as alternatives to methadone for treatment of opioid...

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.

The FDA has approved evinacumab-dgnb (Evkeeza – Regeneron), an angiopoietin-like 3 (ANGPTL3) inhibitor, for adjunctive IV treatment of homozygous familial hypercholesterolemia (HoFH) in patients ≥12 years old. Evinacumab is the first ANGPTL3 inhibitor to be approved in the US.

The FDA has approved the complement C3 inhibitor pegcetacoplan (Syfovre – Apellis) for treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Given as a series of monthly or every-other-month (EOM) intravitreal injections, it is the first drug to become available for use in patients with atrophic dry AMD. Subcutaneous pegcetacoplan was approved earlier as Empaveli for treatment of paroxysmal nocturnal hemoglobinuria.

The FDA has approved the complement C5 inhibitor avacincaptad pegol (Izervay – Iveric) for intravitreal treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Avacincaptad pegol is the second complement inhibitor to be approved in the US for this indication; pegcetacoplan (Syfovre), a complement C3 and C3b inhibitor, was approved earlier.