FDA approves three Amneal generics
PETERSON, N.J. Amneal Pharmaceuticals recently received approval from the Food and Drug Administration to manufacture three generic drugs: Primidone 50 mg and 250 mg, Cyclobenzaprine 10 mg, and Demeclocycline 150 mg and 300 mg.
Demeclocycline is the generic of Stonebridge Pharma’s Declomycin, which is used to treat infections caused by susceptible strains in conditions like Rocky Mountain spotted fever and respiratory tract infections. Primidone is the generic of Valeant Pharmaceuticals Mysoline, used to treat epileptic seizures. Cyclobenzaprine is the generic of the muscle spasm relief medication Flexeril by McNeil Consumer Healthcare.
These three products are the company’s 15th, 16th and 17th application approvals.
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.