Femlyv (Millicent), an orally disintegrating tablet containing ethinyl estradiol and norethindrone acetate, has been approved by the FDA for prevention of pregnancy in females with a body mass index (BMI) ≤35 kg/m². It is the first hormonal contraceptive to become available in an orally disintegrating tablet formulation. Traditional oral and chewable tablets containing ethinyl estradiol and norethindrone acetate in a wide range of doses, including those found in Femlyv, have been available in the US for years.

The progestin levonorgestrel is available over the counter for emergency contraception as two 0.75-mg tablets taken 12 hours apart (generic formulations of Plan B) and as a single 1.5-mg tablet taken once (Plan B One-Step, and generics). A third emergency contraceptive, ulipristal (Ella – Watson), is available with a prescription.1 It appears that, pursuant to a court order, Plan B One-Step (but not the generic products), which was previously available over the counter from a pharmacist only for women 17 years and older, will now be available directly from pharmacy shelves with no age...

The FDA recently approved Skyla (Bayer), the first new intrauterine device (IUD) in the US in 12 years. It releases levonorgestrel, a synthetic progestin, over a period of 3 years. A table summarizing contraceptive methods available in the US appears on page 22.

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 FDA has approved Twirla (Agile Therapeutics), a transdermal contraceptive patch containing the estrogen ethinyl estradiol and the progestin levonorgestrel, for use in women with a BMI <30 kg/m². It is the second contraceptive patch to become available in the US; Xulane, a patch that delivers ethinyl estradiol and the progestin norelgestromin, has been available since 2014.

An FDA Advisory Committee has recommended over-the-counter (OTC) marketing of Plan B (Barr), an emergency contraceptive "pill pack" that contains two 0.75-mg tablets of levonorgestrel to be taken 12 hours apart (Medical Letter 2000; 42:10). Plan B is one of two FDA-approved products for this indication. The Preven Emergency Contraceptive Kit (Medical Letter, 40:102, 1998) includes four tablets, each containing 0.25 mg of levonorgestrel and 50 ╡g of ethinyl estradiol; these are taken 2 at a time 12 hours apart (the "Yuzpe regimen") and are available only by...

The FDA has approved ospemifene (os pem’ i feen; Osphena – Shionogi), an estrogen agonist/antagonist, for oral treatment of moderate to severe dyspareunia in postmenopausal women. Ospemifene is the fourth estrogen agonist/antagonist to be marketed in the US, but it is the only one that has an estrogen-like effect on vaginal epithelium. The other three, tamoxifen (Nolvadex, and generics), toremifene (Fareston), and raloxifene (Evista), are used for treatment and prevention of breast cancer and osteoporosis.

The FDA has approved Kyleena (Bayer), an intrauterine device (IUD) that releases the synthetic progestin levonorgestrel, for prevention of pregnancy. It is the fourth levonorgestrel-releasing IUD to be approved in the US. Like Mirena, which has been available since 2000, Kyleena is approved for up to 5 years of use.

Raloxifene (Evista - Lilly), a benzothiophene that acts on estrogen receptors, has recently been marketed for prevention of postmenopausal osteoporosis. Only estrogen (alone or in combination with a progestin) and the bisphosphonate alendronate (Fosamax) were previously approved by the FDA for this indication.

An old conjugated estrogens vaginal cream (Premarin Vaginal Cream - Wyeth) has been newly approved by the FDA specifically for treatment of moderate to severe dyspareunia due to vulvar and vaginal atrophy associated with menopause. Synthetic conjugated estrogens A vaginal cream (Barr) has also been approved for this indication, but has not yet been marketed.