FDA to allow dispensing of GSK’s Type 2 diabetes drug Avandia in retail pharmacies again
SILVER SPRINGS, Md. – Federal regulators are lifting some restrictions on a diabetes drug that were placed two years ago after studies linked the drug to increased cardiovascular risk.
The Food and Drug Administration said Monday it would require removal of some restrictions on GlaxoSmithKline’s Type 2 drug Avandia (rosiglitazone), which were placed following findings from a series of studies starting in 2007 of an increased risk in heart attacks in patients taking it. The agency’s decision was based on results of a clinical trial showing no elevated risk of heart attack or deaths in patients taking Avandia compared with those taking standard-of-care diabetes drugs.
"Our actions today reflect the most current scientific knowledge about the risks and benefits of this drug," FDA Center for Drug Evaluation and Research director Janet Woodcock said. "Given these new results, our level of concern is considerably reduced; thus, we are requiring the removal of certain prescribing restrictions."
In May 2011, the FDA announced that as of November of that year, Avandia would no longer be available in retail pharmacies and would only be available through mail order. Once the latest changes are finalized, the FDA said Monday, it will be available in retail pharmacies again.
First wave of Certified Specialty Pharmacist credential recipients includes four from Diplomat
FLINT, Mich. — Four pharmacists from Diplomat are among the 49 across the country who have received certification from the Specialty Pharmacy Certification Board, Diplomat said Monday.
Diplomat said VP clinical services Gary Rice, clinical technology manager Michael Crowe, pharmacy manager Nicole Hubach and clinical manager Ryan Nolan had received the SPCB’s Certified Specialty Pharmacist endorsement. The SPCB announced on Nov. 11 the first 49 pharmacists to become CSPs. The tests for the credential were administered in October.
"I’m very excited to be one of the first Diplomat pharmacists to earn the CSP credential," Crowe said. "Diplomat has provided me with many opportunities to develop my expertise in specialty pharmacy. I encourage pharmacists and pharmacy students to explore the industry, as its growth will continue for the foreseeable future."
FDA approves J&J’s Olysio for hepatitis C
TITUSVILLE, N.J. — The Food and Drug Administration has approved a new treatment made by Johnson & Johnson for hepatitis C, the drug maker said.
J&J subsidiary Janssen Therapeutics announced the approval of Olysio (simeprevir) for treatment of chronic hepatitis C in combination with the drug ribavirin and biotech drugs called pegylated interferons. The drug is meant for adults with HCV genotype 1 with compensated liver disease, including cirrhosis. The company said the drug may benefit patients who have the chronic form of the disease, including those who have not received treatment before or who have failed prior interferon-based therapy.
"Given the complexity of the condition, Olysio was studied in a number of different patient populations, including individuals who have relapsed or failed to respond to previous treatments," Olysio clinical trial investigator and Mount Sinai School of Medicine professor Douglas Dieterich said. "The FDA approval of Olysio is an important milestone for people living with chronic hepatitis C, as it means that patients have a new treatment option with the potential to cure this challenging disease."