FDA panel to review GSK blood-clotting drug
WASHINGTON A Food and Drug Administration panel will meet at the end of the month to review a drug by GlaxoSmithKline that is designed to treat chronic immune thrombocytopenic purpura, according to Reuters.
The disease is a disorder in which the blood does not clot properly, which leads to a low number of platelets in the blood which blocks clotting.
The advisory committee will meet on May 30 in Chicago during the annual meeting of the American Society for Clinical Oncology.
GSK is in a race right now with Amgen to get approval for their ITP drug. Last month, the FDA delayed Amgen’s drug romiplastin decision for approval, so the agency could review more information about the drug.
Mylan, Teva to begin shipping generic Requip
PITTSBURGH Mylan Pharmaceuticals has received approval from the Food and Drug Administration for its application for Ropinirole hydrochloride tablets and has announced it will begin shipping the drug immediately. Teva also announced the availability of its version of the tablets.
The drug is the generic form of GlaxoSmithKline’s Requip, which is used to treat moderate-to-severe primary restless leg syndrome. The generic will be available in 0.35 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg strengths.
According to IMS Health, the drug had sales of about $518 million in 2007.
Teva’s Q1 results show more than 25 percent sales increase
JERUSALEM Teva has released the results of its first quarter 2008, according to published reports.
Profits for the company fell by 57 percent to $147 million, but that was in large part to a $382 million acquisition charge the company suffered for buying the biotech company CoGenesys.
Teva did have a net income of $529 million, which beat the analysts’ forecast. Sales in North America increased by 27.3 percent for the quarter to $1.4 billion.
“The year is off to a strong start for Teva across all of our major businesses. It was a particularly outstanding quarter for Copaxone, which crossed the $500 million mark in in-market quarterly sales and became, for the first time, the number one global multiple sclerosis therapy,” said Shlomo Yanai, Teva’s chief executive officer.