The FDA has approved ticagrelor (Brilinta – AstraZeneca), an oral antiplatelet drug, for use with low-dose aspirin to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS). It will compete with clopidogrel (Plavix) and prasugrel (Effient) for such use. Clopidogrel is expected to become available generically in the US within the next few months.

The FDA has approved ingenol mebutate (Picato – Leo) for topical treatment of actinic keratoses (AKs). The new drug is derived from the sap of the Euphorbia peplus plant, a traditional folk remedy for warts and other skin lesions.

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 vedolizumab (Entyvio - Takeda), an intravenous integrin receptor antagonist, for treatment of moderate to severe ulcerative colitis or Crohn's disease in adults who have not responded to, lost response to, or cannot tolerate standard treatment. Natalizumab (Tysabri), another integrin receptor antagonist, has been available for several years for treatment of Crohn's disease and multiple sclerosis.

The FDA has approved pembrolizumab (Keytruda – Merck), a human programmed death receptor-1 (PD-1) blocking antibody, for treatment of unresectable or metastatic melanoma that has progressed following treatment with ipilimumab (Yervoy) and, if the patient is BRAF V600 mutation positive, a BRAF inhibitor. It is the fi rst PD-1 inhibitor to be marketed in the US. Nivolumab, another PD-1 inhibitor, is available in Japan. Pembrolizumab was previously known as lambrolizumab.

The FDA has approved two new long-acting injectable formulations of second-generation antipsychotics for treatment of schizophrenia: aripiprazole lauroxil (Aristada – Alkermes), which is given once every 4-6 weeks, and paliperidone palmitate (Invega Trinza – Janssen), which is given once every 3 months. Once-monthly injectable formulations of aripiprazole (Abilify Maintena) and paliperidone palmitate (Invega Sustenna) were approved earlier.

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 Otovel (Arbor), a combination of the fluoroquinolone antibiotic ciprofloxacin 0.3% and the corticosteroid fluocinolone acetonide 0.025%, for otic treatment of acute otitis media with tympanostomy tubes (AOMT) in children ≥6 months old. It is the second fluoroquinolone/corticosteroid combination to be approved for this indication; ciprofloxacin 0.3%/dexamethasone 0.1% (Ciprodex) has been available for many years. In December 2015, a suspension of ciprofloxacin 6% (Otiprio) was approved for otic treatment of bilateral otitis media with effusion in children...

The FDA has approved the fully human monoclonal antibody bezlotoxumab (Zinplava – Merck) for use with antibacterial drug treatment to reduce recurrence of Clostridium difficile infection (CDI) in adults with CDI at high risk for recurrence. It is the first drug to be approved for this indication.