A new once-daily, low-dose oral formulation of doxycycline monohydrate (Oracea - CollaGenex) has been approved by the FDA for treatment of inflammatory papules and pustules associated with rosacea in adults.

A combination tablet containing estradiol and drospirenone (Angeliq - Berlex) recently became available for treatment of moderate to severe menopausal symptoms in women with an intact uterus. Since the last Medical Letter issue reviewing such devices,1 more continuous glucose monitoring (CGM) systems have become available. Five devices available now, and two expected to be marketed soon, are listed in the table on page 14. The FDA has approved continuous glucose devices only for the observation of glucose trends.

Ixabepilone (ix ab ep' i lone; Ixempra - Bristol-Myers Squibb), a semisynthetic epothilone analog, has been approved by the FDA for treatment of advanced breast cancer. It is indicated for use in combination with capecitabine (Xeloda - Roche) for treatment of locally advanced or metastatic breast cancer after failure of an anthracycline such as doxorubicin (Adriamycin) and a taxane such as paclitaxel (Taxol, and others). It is also approved as monotherapy for treatment of metastatic or locally advanced breast cancer after an anthracycline, a taxane and capecitabine have...

Bevacizumab (Avastin - Genentech) is a recombinant humanized monoclonal antibody that binds to vascular endothelial growth factor and prevents it from binding to receptors on endothelial cells, inhibiting formation of new blood vessels. Previously approved by the FDA for use in combination regimens for first-line treatment of metastatic colon cancer and metastatic non-small cell lung cancer, and used off-label for treatment of agerelated macular degeneration, it has now also been approved by the FDA for use in combination with paclitaxel (Taxol, and others) for first-line treatment of...

The FDA has approved use of tadalafil (Adcirca - Lilly/United Therapeutics) for treatment of pulmonary arterial hypertension (PAH).

The FDA has approved a recombinant human papillomavirus (HPV) vaccine (Cervarix – GlaxoSmithKline) for use in girls and women 10-25 years old to prevent infection with HPV types 16 and 18, which have been associated with cervical cancer. A recombinant quadrivalent HPV vaccine (Gardasil – Merck) already on the market in the US prevents infection with HPV types 6, 11, 16 and 18.

Chemotherapy can result in premature menopause and infertility in young women. Pretreatment fertility counseling followed by appropriate action may prevent some of these undesirable consequences.

The FDA has approved isavuconazonium sulfate (Cresemba – Astellas) for intravenous and oral treatment of invasive aspergillosis and invasive mucormycosis in adults. Isavuconazonium sulfate is a prodrug of isavuconazole, a broad-spectrum triazole antifungal.

The FDA has approved two new inhalers for long-term maintenance treatment of chronic obstructive pulmonary disease (COPD). Seebri Neohaler (Novartis) contains the long-acting anticholinergic glycopyrrolate. Utibron Neohaler (Novartis) contains both glycopyrrolate and the long-acting beta2-adrenergic agonist (LABA) indacaterol. Glycopyrrolate/indacaterol is the third fixed-dose combination of a long-acting anticholinergic and a LABA to become available in the US; umeclidinium/vilanterol (Anoro Ellipta) and tiotropium/olodaterol (Stiolto Respimat) were approved...

The FDA has approved voretigene neparvovec-rzyl intraocular suspension (Luxturna – Spark), an adeno-associated virus vector-based gene therapy, for treatment of confirmed biallelic RPE65 mutation-associated retinal dystrophy in patients who have viable retinal cells. It is the first gene replacement therapy approved in the US that targets a disease caused by mutations in a specific gene and the first pharmacologic treatment to be approved for this disorder.