Eli Lilly’s Strattera wins approval from FDA for ADHD
INDIANAPOLIS The Food and Drug Administration has approved Eli Lilly’s Strattera for the maintenance treatment of attention deficit hyperactivity disorder in children and adults. It is the first non-stimulant to treat ADHD in children, adolescents and adults.
“In the past, our understanding of ADHD treatment was limited to clinical data on short-term use, meaning a few weeks or a couple of months,” said A.J. Allen, Strattera global medical director for Eli Lilly. “For the first time, clinicians have guidance that Strattera is effective for up to a year in patients who respond well to initial treatment.”
The drug was approved after Lilly submitted 18 months worth of clinical trial data which showed that the drug was significantly greater than the placebo in measuring response rates. Also, it had a much bigger impact on reducing relapse rates as compared to the placebo: 2.5 percent for Strattera users compares to 12.2 percent for placebo users.
According to the FDA, Strattera had sales of over $535 million last year.
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.