The Drug Enforcement Administration (DEA) has reclassified all hydrocodone combination products as schedule II controlled substances; they were previously classified as schedule III. Hydrocodone alone (Zohydro ER) is already a schedule II controlled substance.

Metreleptin (Myalept – Amylin), a recombinant leptin analog produced in E. coli, has been approved by the FDA to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy. It has not been approved to date for the treatment of partial lipodystrophies, including those associated with the use of protease inhibitors in patients with HIV. Metreleptin is approved in Japan for the treatment of any lipodystrophy disorder.

Tiotropium bromide, an inhaled long-acting anticholinergic available since 2004 as a dry powder inhaler (Spiriva Handihaler) for once-daily treatment of chronic obstructive pulmonary disease (COPD), has now also been approved in an inhalation spray formulation (Spiriva Respimat – Boehringer Ingelheim). According to the manufacturer, the Respimat device improves delivery of tiotropium to the lungs because, unlike with the Handihaler, it is not dependent on the strength of the patient’s breath intake.

The FDA has approved another fixed combination of the antibiotic clindamycin phosphate and the oxidizing agent benzoyl peroxide (Onexton Gel 1.2%/3.75% – Valeant) for topical treatment of acne in patients ≥12 years old. Topical products containing the same drugs have been available for many years. Onexton Gel contains a new strength of benzoyl peroxide.

The recent report of a reduction in cardiovascular mortality in patients with type 2 diabetes treated with the SGLT2 inhibitor empagliflozin (Jardiance) was published soon after the FDA issued new warnings about an increased risk of fractures with canagliflozin (Invokana).

The FDA has approved a rectal foam formulation of the corticosteroid budesonide (Uceris - Salix/Valeant) for induction of remission in patients with active mild to moderate distal ulcerative colitis (UC) extending up to 40 cm from the anal verge. Budesonide is also available as oral extended-release tablets (also branded as Uceris) for use in patients with UC and as oral enteric-coated tablets (Entocort EC, and generics) for treatment of Crohn's disease.

The FDA has approved filgrastim-sndz (Zarxio – Sandoz), a biosimilar of the recombinant human granulocyte colony-stimulating factor filgrastim (G-CSF; Neupogen), which has been available in the US since 1991. Zarxio is the first biosimilar product to be approved in the US; it has been available in Europe as Zarzio since 2009.

The FDA has approved sebelipase alfa (Kanuma – Alexion), a recombinant form of lysosomal acid lipase (LAL), for enzyme replacement therapy in patients with LAL deficiency. Sebelipase alfa is the first drug to be approved in the US for treatment of LAL deficiency, a rare autosomal recessive storage disease.

The FDA has approved a sublingual powder formulation of nitroglycerin (GoNitro – Espero) for prevention or acute relief of an attack of angina pectoris. It is the first powder formulation of nitroglycerin to become available in the US. Most patients with angina use sublingual nitroglycerin tablets (Nitrostat, and generics). Translingual spray formulations of nitroglycerin (NitroMist, Nitrolingual Pumpspray, and generics) are also available.

The FDA has approved telotristat ethyl (Xermelo – Lexicon), a tryptophan hydroxylase inhibitor, for use in combination with a somatostatin analog (SSA) for treatment of carcinoid syndrome diarrhea inadequately controlled with SSA therapy alone. Telotristat ethyl is the first oral drug to be approved in the US for this indication.