At a joint meeting of the FDA's Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, panelists agreed that the risk of venous thromboembolic events (VTEs) associated with the Ortho Evra patch was greater than the VTE risk associated with combination oral contraceptives (COCs) that contain 35 mcg or less of ethinyl
An OC approved in May 2006 both extends combination active therapy to 84 days and adds low-dose estrogen to the usual 7-day HFI (ethinyl
estradiol 30 mcg/levonorgestrel 150 mcg for 84 days plus ethinyl
estradiol 10 meg for 7 days; Seasonique, Barr Laboratories).
Indication Quartette(TM) (levonorgestrel/ethinyl
estradiol and ethinyl
estradiol) tablets are indicated for use by women to prevent pregnancy.
Major Finding: The relative risk of confirmed VTE in users of OCs containing 30-40 mcg of ethinyl
estradiol with levonorgestrel was 2.
Insulin resistance improved significantly in the metformin group, but insulin resistance and arterial stiffness worsened in the ethinyl
estradiol/cyproterone acetate group (Diabetes Care 2007;30:471-8).
Mylan CEO Heather Bresch commented: "The approval and immediate launch of our Levonorgestrel and Ethinyl
Estradiol Tablets USP, 0.
Jensen's coinvestigators in 798 healthy women seeking contraception, reported significantly fewer bleeding/spotting days among women given E2V/DNG than those given ethinyl
estradiol 20 mcg/levonorgestrel 100 mcg (EE/LNG): 17.
The type of estrogen treatment was unknown for 25 women, but in all other cases the treated women had been prescribed either diethylstilbestrol (DES) or ethinyl
estradiol; DES was in use before 1971.
to tone down its advertising for Yaz (drospirenone and ethinyl
Dogterom and his associates conducted two crossover studies to determine whether treatment with amoxicillin and doxycycline can affect the pharmacokinetics of the ethinyl
estradiol and etonogestrel that are released from the NuvaRing.
Both regimens include 84 days of 30 meg ethinyl
estradiol and 150 mcg of levonorgestrel, but Seasonique substitutes 7 days of 10 mcg ethinyl
estradiol monotherapy for the 7 days of placebo in the Seasonale regimen.
4 mg of norethindrone and 35 [micro] g of ethinyl