The FDA has approved Duavee (Pfizer), a fixed-dose combination of conjugated estrogens and the new selective estrogen receptor modulator (SERM) bazedoxifene, for treatment of moderate to severe vasomotor symptoms and for prevention of osteoporosis in postmenopausal women with an intact uterus. Bazedoxifene is an estrogen agonist/antagonist with estrogen-like effects on bone and antiestrogen effects on the uterus. It is the second SERM to be approved for prevention of osteoporosis; raloxifene (Evista, and generics) has been available as a single agent for this indication since...

The FDA has approved ceftazidime/avibactam (Avycaz – Actavis) for IV treatment of complicated urinary tract and intra-abdominal infections in adults who have limited or no other treatment options. Ceftolozane/tazobactam (Zerbaxa – Cubist), another cephalosporin/beta-lactamase inhibitor combination, was approved in 2014.

A patient-controlled fentanyl iontophoretic transdermal system (Ionsys – The Medicines Company) is now available for short-term management of acute postoperative pain in adults requiring opioid analgesia in the hospital. Before using Ionsys, patients must be titrated to a comfortable level of analgesia with another opioid formulation.

The FDA has approved a 10% nanoemulsion gel formulation of the porphyrin-based photosensitizer aminolevulinic acid hydrochloride (ALA; Ameluz – Biofrontera) for use in combination with a narrowband red light photodynamic therapy (PDT) lamp (BF-RhodoLED) for treatment of actinic keratoses (AKs) of mild to moderate severity on the face and scalp. A 20% ALA solution (Levulan Kerastick) approved for use in combination with blue light PDT (BLU-U) has been available in the US since 2002.

The FDA has approved the interleukin (IL)-6 inhibitor sarilumab (Kevzara – Sanofi/Regeneron) for treatment of polymyalgia rheumatica (PMR) in adults who had an inadequate response to corticosteroids or cannot tolerate a corticosteroid taper. Sarilumab is the first biologic drug to be approved for treatment of PMR; it was previously approved for treatment of rheumatoid arthritis.

Several currently available antiemetic drugs can prevent vomiting caused by cancer chemotherapy. Anticancer drugs that cause vomiting are listed in the table below.

Cholinesterase inhibitors are now used routinely in patients with dementia. Rivastigmine transdermal system (Exelon Patch - Novartis), a patch formulation of the cholinesterase inhibitor rivastigmine tartrate, has been approved by the FDA for treatment of mild to moderate dementia associated with Alzheimer's or Parkinson's disease. An oral formulation of rivastigmine tartrate has been available in the US since 2000,2 but gastrointestinal adverse effects possibly related to rapidly rising serum concentrations have limited its use.

Natalizumab (Tysabri - Elan and Biogen) is a monoclonal antibody approved for induction and maintenance treatment of moderate to severe Crohn's disease (CD) refractory to conventional therapies and inhibitors of tumor necrosis factor (TNF). Initially approved in 2004 for the treatment of multiple sclerosis (MS), natalizumab was temporarily withdrawn from the market after 3 patients developed progressive multifocal leukoencephalopathy (PML). It is now available for treatment of both MS and CD through a restricted distribution program.

Rufinamide (Banzel - Eisai), a triazole derivative structurally unrelated to other marketed antiepileptic drugs (AEDs), has been approved by the FDA for treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients ≥4 years old.

Milnacipran (Savella - Forest), an oral selective serotonin and norepinephrine reuptake inhibitor (SNRI), is the third drug approved by the FDA for management of fibromyalgia. The 2 others are pregabalin, a gammaaminobutyric acid (GABA) analog also approved for treatment of diabetic neuropathy, post-herpetic neuralgia and epilepsy, and duloxetine, an SNRI also approved for treatment of depression, diabetic neuropathy and generalized anxiety disorder.