Glenmark Pharmaceuticals' calcipotriene cream, a generic version of Leo Pharma's Donovex Cream, has received tentative approval from the FDA as a treatment for plaque psoriasis. Glenmark will be authorized to commercialize the treatment when the FDA grants final approval to the abbreviated new drug application.
The number of cases of invasive methicillin-resistant Staphylococcus aureus infections in the U.S. decreased by 30,800 from 2005 to 2011. Data published in JAMA Internal Medicine showed that of the estimated 80,461 cases in 2011, 48,353 were health care-associated community-onset cases and 16,560 were community-onset. There was a 31.2% decline in all infection categories: 54.2% in hospital-onset infections, 27.7% in HACO infections and 5% in community-onset infections.
The FDA granted marketing approval of Glenmark Generics' clotrimazole cream USP 1%, an anti-fungal treatment for candidiasis and tinea versicolor. The drug is a copy of Taro Pharmaceutical Industries' Clotrimazole Cream USP.
Cepheid said it has received FDA clearance to market a test designed to identify drug-resistant staph infections. The test can help physicians detect skin infections more accurately within one hour and decide on the best treatment option.