The FDA has approved the marketing of tolvaptan (Samsca - Otsuka), an oral vasopressin receptor antagonist, for treatment of hypervolemic or euvolemic hyponatremia due to congestive heart failure (CHF), cirrhosis or the syndrome of inappropriate antidiuretic hormone secretion (SIADH). A similar drug, conivaptan (Vaprisol) is already available for intravenous (IV) treatment of euvolemic hyponatremia in hospitalized patients. Tolvaptan was approved by the FDA for both inpatient and outpatient use, but it should be started in a hospital.

Among patients with chronic heart failure, those with a left ventricular ejection fraction (LVEF) ≤40% are considered to have heart failure with reduced ejection fraction (HFrEF). Patients with a LVEF ≥50% are considered to have heart failure with preserved ejection fraction (HFpEF). Those with a LVEF of 41-49% are an intermediate group more similar to patients with HFpEF.

The FDA has approved Furoscix (scPharmaceuticals), a subcutaneous formulation of the loop diuretic furosemide administered via a single-use, on-body infusor, for treatment of congestion due to fluid overload in adults with New York Heart Association (NYHA) Class II-III chronic heart failure (HF). Furosemide (Lasix, and generics) has been available for years in oral and IV formulations.

The FDA has approved siponimod (Mayzent – Novartis), a sphingosine 1-phosphate (S1P) receptor modulator, for oral treatment of adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome (initial neurological episode), relapsing-remitting disease, and active secondary progressive MS (SPMS). Siponimod is the second S1P receptor modulator to be approved in the US; fingolimod (Gilenya), which is approved for oral treatment of relapsing forms of MS in patients ≥10 years old, was the first. The purine antimetabolite cladribine (Mavenclad) was also...

The FDA has approved the oral multikinase inhibitor midostaurin (Rydapt – Novartis) for first-line treatment, in addition to standard chemotherapy, of adults with FLT3 (fms-like tyrosine kinase 3) mutation-positive acute myeloid leukemia (AML). About 30% of patients with AML have FLT3 mutations. Midostaurin is also approved as a single agent for treatment of adults with aggressive systemic mastocytosis, systemic mastocytosis with associated hematological neoplasm, or mast-cell leukemia. In mastocytosis, midostaurin targets mutant c-KIT, not FLT3.In a randomized, double-blind trial, 717...

Photopheresis is a new technique recently approved by the US Food and Drug Administration for treatment of cutaneous T-cell lymphoma. It combines oral administration of a photoactivatable cytotoxic drug with leukapheresis and extracorporeal exposure of leukocytes to long-wave ultraviolet light (UVA). This procedure requires use of a 'UVAR Instrument' manufactured by Therakos, a subdivision of Johnson and Johnson.

The FDA has approved an inhalation solution formulation of the long-acting antimuscarinic agent (LAMA) glycopyrrolate (Lonhala Magnair – Sunovion) for maintenance treatment of chronic obstructive pulmonary disease (COPD). The new formulation is delivered using a portable, handheld, electronic nebulizer. Glycopyrrolate is also available as a dry powder inhaler, both alone (Seebri Neohaler) and in combination with indacaterol (Utibron Neohaler), and as a metered-dose inhaler in combination with formoterol (Bevespi Aerosphere). Lonhala Magnair is the first nebulized LAMA to become...

The FDA has approved a new interferon beta-1b product (Extavia – Novartis) for treatment of relapsing forms of multiple sclerosis (MS). Extavia is identical to Betaseron (Bayer); both are produced in the same factory and packaged separately.

The FDA has approved the oral poly (ADP-ribose) polymerase (PARP) inhibitor olaparib (Lynparza – Astra-Zeneca) as monotherapy for treatment of women with advanced ovarian cancer who have BRCA1/2 germline mutations and have received at least 3 prior lines of chemotherapy. Olaparib is the first PARP inhibitor to be approved in the US. It is approved outside the US for maintenance treatment of relapsed BRCA-mutated ovarian cancer.

Dichlorphenamide (Keveyis – Taro), an oral carbonic anhydrase inhibitor, has been approved by the FDA for treatment of primary hypokalemic and hyperkalemic periodic paralysis and related variants. Dichlorphenamide is the first drug to be approved in the US for this indication. It was approved as Daranide in 1958 for treatment of glaucoma, but had not been marketed since 2002.