Reports: FDA generic drug chief resigns
NEW YORK — The director of the Food and Drug Administration’s Office of Generic Drugs is stepping down, according to published reports.
Pharmalot, a blog run by journalist Ed Silverman, reported that Greg Geba is leaving the office over differences resulting from a recent reorganization, effective Friday.
In his resignation letter, Geba wrote that the OGD has issued almost 600 complete response letters and approved nearly 200 generic drug applications since the Oct. 1 implementation of the Generic Drug User Fee Amendments.
The Generic Pharmaceutical Association, an industry trade group, expressed concerns that Geba’s departure could lead to "further disruption" at the OGD in the wake of the office having no leader from 2010 to 2012.
"GPhA was disappointed to learn of Dr. Gregory Geba’s departure from the FDA’s Office of Generic Drugs," GPhA president and CEO Ralph Neas said. "Today, 80% of prescriptions dispensed in America are generics. GPhA and its member companies rely on the strength and continuity of the OGD on critical matters such as regulations governing the entry to market of new, cost-saving generic versions of critical medicines, and the implementation of the GDUFA process."
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Alberta pharmacist group ‘shocked’ at planned generic drug price reductions
EDMONTON, Alberta — A plan to significantly reduce generic drug prices in Alberta has drawn criticism from pharmacists in the Canadian province.
The Alberta Pharmacists’ Association said it was "shocked" in response to the provincial government’s 2013 budget, which reduces generic drug prices from 35% to 18% of branded drug prices, effective May 1. Over the past two years, prices have been reduced from 75% to 35%, but the RxA said it supported the government in those cases.
"The cuts are so deep and so fast, it will be impossible for me to react quickly enough to ensure the sustainability of my pharmacy," Rimby, Alberta, pharmacist Patrick Rurka said on behalf of the group. "My patients and community will be the real losers as the health services my pharmacy offers will be compromised. The patients’ needs will either be off-loaded to physicians or will be left untreated."
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Mylan can launch generic diabetes drug in August
PITTSBURGH — Mylan has settled a patent-infringement lawsuit filed by Shionogi over its generic version of a drug for diabetes, Mylan said.
The generic drug maker said that under the agreement, it can launch a generic version of Shionogi’s Fortamet (metformin hydrochloride) extended-release tablets in the 500-mg and 1,000-mg strengths on Aug. 1.
Metformin hydrochloride extended-release tablets in those two strengths had sales of about $125 million during the 12-month period that ended in September, according to IMS Health.
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