Mylan gets regulatory approval for generic Zyban
PITTSBURGH The Food and Drug Administration has approved Mylan’s generic version of a smoking-cessation drug, Mylan said Tuesday.
The FDA approved bupropion hydrochloride extended-release tablets in the 150-mg strength. The drug is a generic version of GlaxoSmithKline’s Zyban.
Various versions of the drug had sales of $9.7 million in 2009, according to IMS Health.
NACDS names Guckian state affairs chief
ALEXANDRIA, Va. The National Association of Chain Drug Stores has named Sandra Kay Guckian, a pharmacy and policy veteran of the organization, as VP state government affairs.
Guckian, nee Sandra Jung, will oversee the work of five state government affairs directors based in regions throughout the U.S., as well as an administrative assistant based at NACDS headquarters. She reports directly to Carol Kelly, NACDS’ SVP government affairs and public policy.
In addition to leading the state government affairs team, Guckian manages state-level legislative and regulatory advocacy in Delaware, Maryland, Pennsylvania, Virginia and the District of Columbia.
Guckian replaces Gary Wirth, who has left the association to pursue other interests, according to NACDS spokesperson Chrissy Kopple. The appointment is effective immediately.
Guckian is one of the longest-serving members of NACDS’ management team, and last served as VP and deputy director of state government affairs. NACDS president and CEO Steve Anderson called her promotion “the latest step in the transformation of NACDS to maximize its strategic focus and effectiveness.
“In her 13 years at NACDS, Sandra has established a reputation as a member-focused, highly substantive and strategically oriented leader who is absolutely passionate about pharmacy,” said Anderson. “Sandra is well equipped to work collaboratively with NACDS member company representatives, with state association partners, and with her dedicated colleagues on the state government affairs team and throughout NACDS to help advance pharmacy at all levels of government for the ultimate benefit of patient care.”
Guckian earned her B.S. in Pharmacy and M.S. in Pharmacy from The University of Texas at Austin College of Pharmacy, and completed an accredited residency at Parkland Memorial Hospital. She has practiced as a pharmacist in a variety of settings including community retail pharmacy, hospital pharmacy and home health care practice.
FDA: Certain prostate cancer drugs may cause other health problems
SILVER SPRING, Md. The Food and Drug Administration is investigating a possible link between drugs commonly used to treat prostate cancer and a risk of serious health problems, the agency said Monday.
The FDA said it was conducting a safety review of gonadotropin-releasing hormone agonists, saying they have been associated with a “small increased risk” for diabetes, heart attack, stroke and sudden death. The agency is suggesting that healthcare professionals monitor men using the drugs, but that patients should not stop using them unless directed to do so. It also cautioned that it had not made any conclusions about whether the drugs cause an increase in the risk of developing heart disease and diabetes.
GnRH agonists include such branded drugs as Abbott’s Lupron (leuprolide acetate), Watson’s Trelstar (triptorelin pamoate) and several generic drugs.