The FDA has approved Quartette (Teva), an extended-cycle combination oral contraceptive containing increasing doses of the estrogen ethinyl estradiol (EE) combined with the progestin levonorgestrel (LNG). The rationale is that a gradual increase in the EE dose may reduce unscheduled bleeding or spotting, a common adverse effect of extended-cycle oral contraceptives.

The androgen receptor inhibitor darolutamide (Nubeqa – Bayer) has been approved by the FDA for use in combination with docetaxel for treatment of metastatic hormone-sensitive prostate cancer (mHSPC). The drug was previously approved for treatment of nonmetastatic castration-resistant prostate cancer (nmCRPC).

Sarecycline (Seysara — Allergan), a new oral tetracycline antibiotic, has been approved by the FDA for once-daily treatment of inflammatory lesions of non-nodular moderate to severe acne in patients ≥9 years old.

Annovera (TherapeuticsMD), a contraceptive vaginal ring that releases segesterone acetate, a synthetic progestin, and ethinyl estradiol, was approved by the FDA in 2018 and is now available. It is the first product to contain segesterone and the second vaginal ring to become available in the US; NuvaRing, which delivers etonogestrel and ethinyl estradiol, was the first. Unlike NuvaRing, which requires use of a new ring each month, the Annovera ring can be used for an entire year, but it must be removed for one week each month.

In 2013 the FDA approved one new drug and a new combination of 2 old drugs as adjuncts to lifestyle changes for chronic weight management. Lorcaserin (lor-ca-SER-in; Belviq – Arena/Esai) is a selective serotonin 2C receptor agonist. Qsymia (Vivus) is a fixed-dose combination of the weight-loss drug phentermine and an extended-release (ER) formulation of topiramate. The new products are approved for use in obese patients (body mass index [BMI] of ≥30 kg/m2) and for patients who are overweight (BMI ≥27 kg/m2) and have one weight-related risk factor such as hypertension, dyslipidemia or...

The FDA has approved suvorexant (Belsomra – Merck), the first orexin receptor antagonist to become available in the US, for treatment of sleep-onset and/or sleep-maintenance insomnia.

Adults with a body mass index (BMI) between 25 and 29.9 kg/m2 are considered overweight. Those with a BMI ≥30 are considered obese. The initial recommendation for any weight loss effort is to achieve a 5-10% reduction in weight, which has been associated with a reduction in the risk of developing type 2 diabetes, hypertension, and dyslipidemia. Diet, exercise, and behavior modification are the preferred methods for losing weight, but long-term weight maintenance can be difficult. Several drugs and devices are FDA-approved for weight reduction and maintenance of weight...

Minoxidil 2% topical solution (Rogaine - Upjohn) has been available in the USA since 1988 for treatment of androgenetic alopecia (Medical Letter, 29:87, 1987). Although available only by prescription, it is advertised on television to the general public.

The FDA has announced that it will lower the age for over-the-counter access to the emergency contraceptive Plan B1 from 18 to 17 years old. In a randomized, controlled trial, the two 0.75-mg levonorgestrel tablets in Plan B, taken 12 hours apart beginning within 72 hours after unprotected intercourse, decreased the overall pregnancy rate to 1.1% (11/976) of women who requested emergency contraception.2 The sooner the drug is taken after coitus, the more effective it is. Nausea and vomiting can occur with Plan B. Fetal malformations have not been associated with pregnancies that occurred...

Gabapentin enacarbil (Horizant – GlaxoSmithKline), a new extended-release (ER) tablet formulation of gabapentin, has been approved by the FDA for treatment of moderate-to-severe restless legs syndrome (RLS). The immediate-release (IR) formulation of gabapentin (Neurontin,and others), which is approved for treatment of epilepsy and postherpetic neuralgia, has been used for many years to treat RLS. Another ER tablet formulation of gabapentin (Gralise) has been approved by the FDA for treatment of postherpetic neuralgia.