The FDA has removed the requirement that mifepristone (Mifeprex, and generics), a progestin receptor antagonist approved for use in a regimen with the prostaglandin E1 analog misoprostol (Cytotec, and generics) for medical termination of pregnancy, must be dispensed in person to the patient.

Sevoflurane (Ultane - Abbott), a volatile liquid fluorocarbon anesthetic delivered as an inhaled vapor, has been approved by the US Food and Drug Administration for induction and maintenance of general anesthesia. It is being marketed as a rapidly eliminated anesthetic suitable for inpatient and outpatient surgery.

Dehydroepiandrosterone (DHEA) is an adrenal androgen now being marketed as a "food supplement"in health food stores. DHEA is not approved for any indication by the US Food and Drug Administration (FDA).

The FDA has approved ipilimumab (Yervoy – Bristol-Myers Squibb), a recombinant human monoclonal antibody, for treatment of unresectable or metastatic melanoma.

Pancreatic enzyme replacement products have been used for years to improve digestion in patients with exocrine pancreatic insufficiency (EPI). These products were initially marketed before formal FDA approval was required; in 1991, however, the FDA told all manufacturers of pancreatic enzyme replacement products that they would have to submit a new drug application by April 2010 in order to keep their products on the market.EPI is a chronic disorder characterized by a deficiency of exocrine pancreatic enzymes, which results in malabsorption, steatorrhea, and weight loss. Irreversible EPI is...

The oral cyclin-dependent kinase (CDK) 4/6 inhibitor abemaciclib (Verzenio – Lilly) has been approved by the FDA for use in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence.1It was previously approved for the same indication, but patients were also required to have a Ki-67 score ≥20%. About 70% of all breast cancers are HR-positive and HER2-negative. Ki-67 is a...

Octreotide acetate (Sandostatin - Sandoz), a synthetic octapeptide that mimics the actions of somatostatin, was recently approved by the US Food and Drug Administration for symptomatic treatment of patients with metastatic carcinoid or VIPomas (vasoactive intestinal peptide-secreting tumors).

Three nicotine-releasing adhesive patches for the skin (Habitrol - Ciba-Geigy; Nicoderm - Marion Merrell Dow; and PROSTEP - Lederle) have been approved by the US Food and Drug Administration to aid withdrawal from smoking. Nicotrol (Parke-Davis) may also be approved soon. All the manufacturers recommend using the patches in conjunction with a behavioral modification program.

Desogen (Organon) and Ortho-Cept (Ortho), two oral contraceptives each containing a low dose (30 mcg) of the estrogen ethinyl estradiol plus 150 mcg of the progestin desogestrel, were recently approved by the US Food and Drug Administration for marketing in the USA. They are the first US oral contraceptives to contain desogestrel, which is widely used in oral contraceptive combination products in other countries. Desogestrel is one of three new progestins (norgestimate and gestodene are the others) considered less androgenic than previously available progestins (L Speroff et al, Obstet...

Enoxaparin (Lovenox - Rh ne-Poulenc Rorer), the first low-molecular-weight heparin to become commercially available in the USA, was recently approved by the US Food and Drug Administration for prevention of deep vein thrombosis following hip replacement. Five other products have been marketed in Europe.