The FDA has approved the use of tranexamic acid (Lysteda – Ferring), an oral antifibrinolytic, for treatment of menorrhagia. Tranexamic acid has been used for this purpose in Europe for decades, and is available without a prescription in some countries. It has been available in the US since 1987 for use with coagulation factors in patients with hemophilia undergoing dental extractions.

The FDA has approved dolutegravir (doll-you-TEG-rah-veer; Tivicay – Viiv Healthcare), an integrase strand transfer inhibitor (INSTI), for treatment of HIV-1 infection in adults and in children ≥12 years old who weigh at least 40 kg. It is the third INSTI to be approved by the FDA; raltegravir and elvitegravir were approved earlier.

The FDA has approved avanafil (Stendra – Vivus), an oral phosphodiesterase type-5 (PDE5) inhibitor, for treatment of erectile dysfunction. It is the fifth PDE5 inhibitor to be approved for this indication. Advertisements on Stendra’s website imply that it has a faster onset of action than other PDE5 inhibitors.

The FDA has approved flibanserin (Addyi – Sprout) for treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) not caused by another medical or psychiatric condition, the effects of another drug, or relationship difficulties. Flibanserin is the first drug to be approved for treatment of HSDD. It is not approved for use in men or postmenopausal women. Previous FDA reviews of flibanserin in 2010 and 2013 did not result in approval.

The FDA has approved cangrelor (Kengreal – The Medicines Company), an IV P2Y12 platelet inhibitor, as an adjunct to percutaneous coronary intervention (PCI) in patients who have not been pretreated with a P2Y12 inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor.

The FDA has approved elvitegravir (Vitekta – Gilead), an integrase strand transfer inhibitor (INSTI), for use with a protease inhibitor (PI) plus ritonavir and other antiretroviral drugs for treatment of HIV-1 infection in treatment-experienced adults. Elvitegravir is also available in a fixed-dose combination (Stribild) with the pharmacokinetic enhancer cobicistat and the nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) emtricitabine and tenofovir disoproxil fumarate (DF). A similar combination (Genvoya) that includes tenofovir alafenamide instead of tenofovir...

The FDA has approved the Maestro Rechargeable System (EnteroMedics), a subcutaneously implanted device, for use in adults who have not been able to lose weight with a weight loss program within the past 5 years and who have a body mass index (BMI) of 40 to 45, or a BMI ≥35 and at least one obesity-related comorbidity.

The antiplatelet drug clopidogrel (Plavix, and others) reduces major cardiovascular events, but can cause bleeding. Proton pump inhibitors (PPIs) are often used with clopidogrel to prevent gastrointestinal bleeding, however, some evidence suggests that PPIs may interfere with the activation of clopidogrel and diminish its antiplatelet effect. FDA-approved labeling recommends avoiding concurrent use of the PPIs omeprazole and esomeprazole with clopidogrel.

The FDA has approved prabotulinumtoxinA-xvfs (Jeuveau – Evolus) for temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity. Jeuveau is the fourth botulinum toxin product to be approved in the US for this indication (see Table 1). It has been available in South Korea as Nabota since 2014.

An oral formulation of testosterone undecanoate (Jatenzo – Clarus) has been approved by the FDA for treatment of adult men with conditions associated with a deficiency of endogenous testosterone, such as Klinefelter syndrome, orchiectomy, toxic damage from chemotherapy or alcohol, or pituitary-hypothalamic injury from tumors, trauma, or radiation. Jatenzo is not approved for treatment of low testosterone levels solely due to aging. It is the first oral testosterone formulation to be approved in the US.