Lubiprostone (Amitiza), which was previously approved for treatment of chronic idiopathic constipation in adults, has now also been approved in a lower dose for use in women with irritable bowel syndrome with constipation (IBS-C). Since tegaserod (Zelnorm) has been withdrawn from the market,2 lubiprostone is the only drug approved by the FDA for treatment of this common condition.

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...

Methicillin-resistant Staphylococcus aureus (MRSA), which was traditionally a nosocomially-acquired organism but now frequently occurs in the absence of healthcare exposure, is the predominant cause of suppurative skin and soft-tissue infections in many parts of the US. Community-associated MRSA usually causes furunculosis, purulent cellulitis, and abscesses, but necrotizing fasciitis, necrotizing pneumonia, and sepsis can also occur.

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 5% ophthalmic solution of lifitegrast (Xiidra – Shire), a lymphocyte function-associated antigen-1 (LFA-1) antagonist, for treatment of the signs and symptoms of dry eye disease. Lifitegrast is the first LFA-1 antagonist to be approved for any indication in the US.

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 an extended-release orally disintegrating tablet formulation of methylphenidate (Cotempla XR-ODT – Neos Therapeutics) for once-daily treatment of attention-defi cit/hyperactivity disorder (ADHD) in children 6-17 years old. Cotempla XR-ODT is the first extended-release orally disintegrating tablet formulation of methylphenidate to become available in the US.

The FDA has approved revefenacin (Yupelri – Mylan/Theravance Biopharma), a long-acting antimuscarinic agent (LAMA) administered once daily by standard jet nebulizer, for maintenance treatment of chronic obstructive pulmonary disease (COPD). Revefenacin is the second nebulized LAMA to be approved for this indication; glycopyrrolate (Lonhala Magnair), which is administered twice daily with a portable handheld nebulizer, was the first.

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Fezolinetant (Veozah – Astellas), a first-in-class neurokinin 3 (NK3) receptor antagonist, has been approved by the FDA for treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. It is the second nonhormonal treatment to be approved in the US for this indication; a low-dose formulation of the selective serotonin reuptake inhibitor (SSRI) paroxetine mesylate (Brisdelle) was approved in 2013.