Sandoz launches Syeda
PRINCETON, N.J. — The Food and Drug Administration has approved a generic oral contraceptive made by Sandoz, the company said Wednesday.
Sandoz, the generics arm of Swiss drug maker Novartis, announced the launch of Syeda (drospirenone and ethinyl estradiol) tablets in the 3-mg/0.03-mg strength.
The drug is a generic version of Bayer HealthCare Pharmaceuticals’ Yasmin. Yasmin and generic versions of the drug had sales of about $365 million during the 12-month period ended in April, according to IMS Health.
Edison’s EPI-743 granted orphan drug designation
MOUNTAIN VIEW, Calif. — The Food and Drug Administration has granted orphan drug designation to an investigational treatment made by Edison Pharmaceuticals for rare diseases, Edison said Wednesday.
The drug maker announced that the FDA had granted the designation to EPI-743, a drug for inherited mitochondrial respiratory chain diseases, which affect an estimated 60,000 people. The agency grants orphan drug designation to drugs for diseases that affect fewer than 200,000 people in the United States, providing accelerated review of approval applications and market exclusivity periods of seven years, compared with the five years given to most drugs.
Inherited mitochondrial diseases cause defects in how cells make and regulate energy and can affect virtually any organ system in the body, causing such symptoms as central nervous system disorders, diabetes, heart failure, liver failure, deafness, blindness and others.
Medco brings SOCRxATES program to New Mexico
ALBUQUERQUE, N.M. — Pharmacy benefit manager Medco Health Solutions is implementing a program in New Mexico designed to close such medication-related gaps in health care as nonadherence among state employees with chronic conditions, the company said Wednesday.
Medco announced that it had brought its SOCRxATES program to the state, under a collaboration with the University of New Mexico College of Pharmacy, the New Mexico Pharmacists Association and several state authorities, including the State of New Mexico General Services Department, Risk Management Division, New Mexico Retiree Health Care Authority, New Mexico Public Schools Insurance Authority and Albuquerque Public Schools. It originally launched the program in Illinois in 2009.
Medco found through research that more than 1,800 state employees, retirees and their dependents with chronic or complex conditions were not taking all the medicines they needed to stay healthy or following their doctors’ instructions.
“The SOCRxATES program addresses several vital aspects of real healthcare reform,” Medco chief medical officer Glen Stettin said. “It transforms traditional competitors into collaborators; creates a partnership across private business, public employers and local colleges of pharmacy; and leverages advanced pharmacy technology to efficiently identify and effectively close gaps in care for patients who are suffering chronic and complex conditions — patients who account for 96% of all drug costs and 75% of all medical spending.”