The FDA has approved tesamorelin (Egrifta – EMD Serono), an injectable synthetic analog of growth-hormone- releasing factor (GRF), for reduction of excess abdominal fat in patients with lipodystrophy associated with HIV infection. Growth hormone (somatropin – Serostim; EMD Serono) has been available for years for treatment of HIV wasting.

Renal sympathetic denervation is under investigation as a therapeutic option for hypertension that has not responded to ≥3 antihypertensive drugs (resistant hypertension).

The FDA has approved idarucizumab (Praxbind – Boehringer Ingelheim) for urgent reversal of the anticoagulant effect of the direct thrombin inhibitor dabigatran etexilate (Pradaxa). Idarucizumab is the first specific reversal agent to become available for one of the new oral anticoagulants.

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.

The FDA has approved asfotase alfa (Strensiq – Alexion), a recombinant form of tissue-nonspecific alkaline phosphatase, for subcutaneous treatment of perinatal-, infantile-, and juvenile-onset hypophosphatasia. Asfotase alfa is the first treatment to be approved in the US for this rare genetic metabolic disorder.

Apalutamide (Erleada – Janssen) has received accelerated approval from the FDA for treatment of nonmetastatic castration-resistant prostate cancer. It is the first drug to be approved in the US for this indication. Apalutamide is an oral antiandrogen that binds to the ligand-binding domain of the androgen receptor.

Consensi (Coeptis/Burke), a fixed-dose combination of the calcium channel blocker amlodipine (Norvasc, and others) and the COX-2 selective NSAID celecoxib (Celebrex, and generics), has been approved by the FDA for treatment of patients who have hypertension and osteoarthritis.

A transdermal formulation of the second-generation (atypical) antipsychotic asenapine (Secuado – Noven) has been approved by the FDA for once-daily treatment of schizophrenia in adults. Asenapine is the first antipsychotic to become available in a transdermal formulation in the US. A twice-daily sublingual tablet formulation of asenapine (Saphris) has been available since 2009.

The FDA has approved Kimyrsa (Melinta), a new IV formulation of the long-acting lipoglycopeptide antibiotic oritavancin, for treatment of adults with acute bacterial skin and skin structure infections caused by susceptible gram-positive bacteria. Orbactiv (Melinta), another IV formulation of oritavancin, was approved in 2014 for the same indication. Kimyrsa has a smaller infusion volume (250 mL vs 1 L) and a shorter infusion time (1 hour vs 3 hours) compared to Orbactiv (see Table 1).

The oral poly(ADP-ribose) polymerase (PARP) inhibitor olaparib (Lynparza – AstraZeneca) has been approved by the FDA for adjuvant treatment of adults with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative, high-risk early breast cancer who received prior neoadjuvant or adjuvant chemotherapy. The drug was previously approved for treatment of adults with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer who received chemotherapy in the neoadjuvant, adjuvant, or metastatic...