Bedaquiline (bed ak' wi leen; Sirturo – Janssen), a diarylquinoline antimycobacterial, has been given accelerated approval by the FDA as an orphan drug for use in addition to other drugs for treatment of adults with multidrug-resistant pulmonary tuberculosis (MDR-TB). It is the first drug approved specifically to treat MDR-TB.

The FDA has approved levomilnacipran (lee" voe mil na' si pran; Fetzima – Forest), a serotonin and norepinephrine reuptake inhibitor (SNRI), for treatment of major depressive disorder. Levomilnacipran is the more active enantiomer of milnacipran (Savella), which was approved in 2009 for management of fibromyalgia. Fetzima has not been studied in fibromyalgia.

The FDA has approved an inhaled fixed-dose combination of the long-acting anticholinergic umeclidinium (ue mek" li din' ee um) and the long-acting beta₂-adrenergic agonist (LABA) vilanterol (Anoro Ellipta – GSK/Theravance) for once-daily maintenance treatment of chronic obstructive pulmonary disease (COPD). Anoro Ellipta is the first product available in the US that combines two long-acting bronchodilators in a single delivery device.

The FDA has approved luliconazole (Luzu Cream, 1% – Valeant) for treatment of tinea pedis, tinea cruris, and tinea corporis infections.

The FDA has approved a subcutaneously injected formulation of recombinant human parathyroid hormone (Natpara – NPS) as an adjunct to calcium and vitamin D to control hypocalcemia in adults with hypoparathyroidism. Natpara is an 84-amino acid single-chain polypeptide identical to native parathyroid hormone. It is the first parathyroid hormone formulation to be approved for this indication.

Lifileucel (Amtagvi – Iovance), a tumor-derived autologous T-cell immunotherapy, has received accelerated approval from the FDA for one-time treatment of adults with unresectable or metastatic melanoma previously treated with a programmed death receptor-1 (PD-1) inhibitor, and if BRAF V600 mutation-positive, a BRAF inhibitor with or without a mitogen-activated kinase (MEK) inhibitor. It is the first cellular therapy to be approved for use in solid tumors. Accelerated approval of lifileucel was based on objective response rates.

The FDA has approved baloxavir marboxil (Xofluza – Shionogi/Genentech), the first polymerase acidic (PA) endonuclease inhibitor, for single-dose, oral treatment of acute uncomplicated influenza in patients ≥12 years old. Baloxavir is the first drug with a new mechanism of action to be approved for treatment of influenza in almost 20 years.

The oral retinoid isotretinoin (Accutane, and others) is the most effective drug available for treatment of acne.1 The FDA has recently approved a new oral isotretinoin product (Absorica – Cipher/Ranbaxy) for treatment of severe, recalcitrant nodular acne.Isotretinoin can completely clear severe nodulocystic lesions, in some cases leading to remission that can persist for years after treatment is stopped. Mucocutaneous adverse effects include dry skin, dry eye, epistaxis, nasopharyngitis, cheilitis, alopecia, eczema, skin fragility and photosensitivity. Musculoskeletal symptoms,...

The FDA has approved an oral tablet formulation of deferasirox (Jadenu [ jade' new] – Novartis) for once-daily treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients ≥2 years old or chronic iron overload in patients ≥10 years old with non-transfusion-dependent thalassemia syndromes. A once-daily, oral tablet for suspension formulation of deferasirox (Exjade) was approved in 2005 for the same indications.1 Jadenu and Exjade are the only once-daily oral formulations for iron chelation available in the US.No new clinical trials were required...

An oral extended-release formulation of the corticosteroid budesonide (Ortikos – Ferring) is now available for once-daily treatment of mild to moderate active Crohn's disease of the ileum and/or ascending colon in patients ≥8 years old and for maintenance of remission for up to 3 months in adults. Ortikos is the second oral formulation of budesonide to be approved for this indication; Entocort EC, an ileal-release formulation, was the first. A third oral formulation of budesonide (Uceris) is approved for induction of remission in patients with mild to moderate active ulcerative...