FDA accepts application for NSAID painkiller
PHILADELPHIA — The Food and Drug Administration has accepted a regulatory application for a new painkiller from Iroko Pharmaceuticals, the drug maker said Monday.
Iroko is seeking approval for a lower-dose, submicron diclofenac, a non-steroidal anti-inflammatory drug for treating mild to moderate acute pain in adults.
"The FDA’s acceptance of our first [new drug application] filing for lower-dose submicron diclofenac is an important milestone for Iroko," Iroko president and CEO John Vavricka said. "Our goal is to address the significant unmet need in pain management by bringing new options to patients and physicians. We look forward to working closely with the FDA during the review process."
Reports: FDA investigating more than two-dozen compounding pharmacies
NEW YORK — The Food and Drug Administration will inspect about 30 compounding pharmacies that it has deemed "high risk," according to published reports.
Businessweek reported that the FDA started visits to the pharmacies started last month and would continue for the next two months. So far, unsanitary conditions were found at pharmacies in Chicago, Florida, Arkansas and Mississippi.
Regulators have placed greater scrutiny on compounding pharmacies following a nationwide outbreak of fungal meningitis linked to contaminated injectable steroids produced at the New England Compounding Center in Framingham, Mass. So far, the epidemic has sickened 720 people in 20 states, leading to 49 deaths, according to the Centers for Disease Control and Prevention.
CVS Caremark commits $15M to preventive health screenings in multicultural communities
WOONSOCKET, R.I. — CVS/pharmacy will sponsor more than 750 Project Health events in more than 10 cities, offering free health screenings to multicultural communities, the retail pharmacy chain said Monday.
Project Health, or Proyecto Salud in Spanish, will deliver more than $15 million worth of free health screenings in Atlanta, Chicago, Dallas, Detroit, Houston, Los Angeles, Miami, New York, Phiadelphia and Washington, as well as select CVS/pharmacy stores in Puerto Rico.
The tests include body-mass index, blood pressure, cholesterol, glucose and smoking-cessation counseling, as well as dental care screenings in October and bone density screenings in May and November. The company also will offer information and education about issues such as nutrition, stress, breast cancer and others.
"Far too many of the multicultural populations we serve have difficulty accessing preventive care," CVS Caremark chief medical officer and EVP Troyen Brennan said. "Project Health makes it easier for our customers to make their health a priority, offering them health risk assessments free of charge right in their neighborhoods. This program allows us to better reach customers who come from a wide array of ethnic and cultural backgrounds, ensuring that we are able to help all people on their path to better health."
After screenings are complete, staff will help patients through on-site consultations with bilingual nurse practitioners and physician assistants who will analyze results and refer patients who require additional medical attention to no-cost or low-cost medical facilities nearby or to primary care physicians.
Events in 2012, which screened nearly 160,000 people, turned up at least one abnormal screening result in 53% of patients; risk factors for osteoporosis in 51%, overweight and obesity in 51%; at least one abnormal risk factor for heart disease in 47%; and abnormal glucose readings in 32%.