FDA to reassess asthma drugs
WASHINGTON The Food and Drug Administration has requested more information from some pharmaceutical companies manufacturing asthma drugs to further analyze the safety of the medicines, according to Reuters.
Some of the manufacturers asked to provide information from clinical studies were: GlaxoSmithKline for its drugs Advair and Serevent, Novartis for Foradil, AstraZeneca for Symbicort, Mylan for Perforomist, and Sepracor for Brovana. The agency asked the companies back in January for the studies, “in order to further evaluate the safety” when treating asthma.
The companies said it would take several months to submit the information, the FDA said in a notice on its website. The agency plans to ask a panel of outside advisers to review the drugs’ risks and benefits in adults and children in the fall or winter 2008, the notice said.
The request comes just two months after an FDA advisory panel urged for stronger safety warnings on GSK’s Serevent amid reports of deaths in children who used the drug.
Possible new FDA diabetes drug guidelines could delay approvals
SAN DIEGO A draft of new guidelines proposed by the Food and Drug Administration for developing drugs to treat diabetes may lead to a delay of the approval for a new long-acting diabetes drug from Amylin Pharmaceuticals, according to the Associated Press.
The FDA suggested increased testing for macrovascular complications, or diseases affecting large veins, particularly for drugs that are linked to problems with those veins.
That could delay approval of Amylin’s diabetes drug candidate exenatide LAR, a weekly version of its Byetta treatment and a Type 2 injectable diabetes drug, which it co-manufactures with Eli Lilly, Lazard Capital Markets analyst Matthew Osborne wrote in a note to clients Monday. He said the guidelines could make clinical trials of diabetes drugs more expensive and difficult.
FDA approves Ranbaxy’s generic version of Risperdal
NEW DELHI, India Ranbaxy Laboratories has received approval from the Food and Drug Administration for a generic version of Janssen Pharmaceuticals’ schizophrenia drug, Risperdal, according to published reports.
Risperdal is also used to treat such behavior problems as aggression and self-injury, as well as sudden mood changes in teenagers and autism in children. The company has received approval to launch the generic risperidone in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg strengths.
Risperdal had sales of $924 million in 2007.