Myfembree (Myovant/Pfizer), an oral fixed-dose combination of the gonadotropin-releasing hormone (GnRH) receptor antagonist relugolix, the estrogen estradiol, and the progestin norethindrone acetate, has been approved by the FDA for management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. It is the second product to be approved in the US for this indication; Oriahnn, which contains the GnRH receptor antagonist elagolix in combination with estradiol and norethindrone acetate, was approved earlier. Relugolix was approved for...

The FDA has approved Lybalvi (Alkermes), a fixed-dose combination of the second-generation antipsychotic olanzapine (Zyprexa, and generics) and samidorphan, a new opioid antagonist, for treatment of adults with schizophrenia or with manic or mixed episodes of bipolar I disorder. The addition of samidorphan is intended to mitigate the weight gain that occurs with olanzapine. This is the first FDA approval for samidorphan.

The FDA has approved Emblaveo (Abbvie), an intravenously administered fixed-dose combination of the monobactam antibacterial drug aztreonam and the beta-lactamase inhibitor avibactam, for use with metronidazole to treat complicated intra-abdominal infections (cIAIs) in adults.

The third sentence in the adverse effects section (Med Lett Drugs Ther 2015; 57:159) was incorrect. Cobicistat inhibits tubular secretion of creatinine, not reabsorption.

The recent "PROVE IT" trial in patients with coronary heart disease showed clinical benefits associated with reducing LDL cholesterol concentrations lower than the 100 mg/dL (2.59 mmol/L) or less that had been considered optimal.

Anticoagulants are the drugs of choice for treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), collectively referred to as venous thromboembolism (VTE).

The FDA has approved Entresto (Novartis), an oral fixed-dose combination of the neprilysin inhibitor sacubitril and the angiotensin receptor blocker (ARB) valsartan, to reduce the risk of cardiovascular death and heart failure hospitalization in patients with heart failure with reduced ejection fraction. Sacubitril is the first neprilysin inhibitor to become available in the US.

The FDA has approved Winlevi (Sun), a 1% cream formulation of the androgen receptor inhibitor clascoterone, for treatment of acne vulgaris in patients ≥12 years old. It is the first topical androgen receptor inhibitor to be approved by the FDA.

Proton pump inhibitors (PPIs), which are used for treatment of gastroesophageal reflux disease (GERD) and for prevention of upper gastrointestinal adverse effects caused by NSAIDs and aspirin, are one of the most commonly prescribed classes of drugs in the US. All PPIs are similarly effective and generally well tolerated, but their long-term use has been associated with a number of safety concerns. Recommendations addressing these concerns have recently been published.

Nexplanon (Merck), a modified version of the contraceptive implant Implanon (Merck), is now available in the US. Nexplanon contains 68 mg of the progestin etonogestrel and is bioequivalent to Implanon. Both products are single-rod subdermal contraceptives implanted into the inside of the upper arm; both provide reversible effective contraception for up to 3 years.1 Nexplanon has a redesigned preloaded applicator intended to make insertion easier and reduce the risk of improperly placed devices. Proper placement is necessary to ensure adequate contraceptive efficacy and to facilitate future...