Teva’s Jinteli now available
NORTH WALES, Pa. — Generic drug maker Teva Pharmaceutical Industries has launched a generic drug for treating symptoms of menopause.
Teva announced Thursday the availability of Jinteli (norethindrone acetate and ethinyl estradiol) tablets.
The drug is a generic version of Warner Chilcott’s FemHRT and is available in the 1-mg/5-mcg strength.
Auralgan otic solution seized by government officials
SILVER SPRING, Md. — The Food and Drug Administration has seized supplies of a drug used to treat ear infections, under a program the agency started to remove unapproved drugs from the market.
The FDA announced the seizure of about $16.5 million worth of Auralgan otic solution made by Brooks, Ky.-based Integrated Commercialization Solutions. Chapel Hill, N.C.-based Deston Therapeutics manufactures the drug, while ICS warehouses it.
The FDA said Deston’s sale of the drug violates federal law because it does not have approval from the FDA, which issued a warning letter to the company in February 2010.
The FDA started the Unapproved Drugs Initiative in 2006 to target companies selling drugs that have not gone through the agency’s approval process. In most cases, the drugs are in a sort of regulatory limbo, having entered the market before the FDA adopted its current drug-safety standards in 1938, with some of them existing since the 1800s.
Sean Whelan named Diplomat’s new CFO
FLINT, Mich. — Diplomat Specialty Pharmacy has hired a new CFO, the company said.
Diplomat announced the appointment of Sean Whelan, citing his experience as a CFO in the healthcare industry. Whelan will report directly to president and CEO Phil Hagerman.
“Sean’s comprehensive financial background is exactly what we need as we continue to create new products and services for the specialty pharmacy industry,” Hagerman said. “His experience in all areas of finance and managing a publicly held healthcare company brings the needed financial platform to support our growth.”
Before Diplomat hired him, Whelan worked for InfuSystem Holdings, a company that supplies infusion pumps for cancer patients. Before that, he worked in financial positions for Ford Motor from 1996 to 2007.