Mylan launches generic Famvir
PITTSBURGH — Mylan has launched a generic drug for treating herpes, the company said Wednesday.
Mylan announced the launch of famciclovir tablets in the 125-mg, 250-mg and 500-mg strengths. The drug is a generic version of Novartis’ Famvir.
Branded and generic versions of the drug had sales of $196 million in 2010, according to IMS Health.
Rituxan OKed as treatment for two inflammatory diseases
SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Genentech for the treatment of two rare inflammatory disorders, the agency said.
The FDA approved Rituxan (rituximab), in combination with a type of steroid known as glucocorticoids, to treat patients with Wegener’s granulomatosis and microscopic polyangiitis. Both disorders cause inflammation of the blood cells, also known as vasculitis, which can lead to tissue damage. WG mostly affects the respiratory tract, while MPA affects the kidneys, lungs, nerves, skin and joints. Both are considered orphan diseases because they affect fewer than 200,000 people in the United States, but their causes remain unknown.
“This new indication for Rituxan provides the first approved therapy for these two orphan diseases,” FDA Office of Drug Evaluation II director Curtis Rosebraugh said.
GPhA applauds new IMS Institute report
WASHINGTON — The main trade group for the generic drug industry is heralding a new cost analysis by the IMS Institute for Healthcare Informatics showing that generic drugs can reduce co-payments by up to 80%.
According to the analysis, contained in the report “The Use of Medicines in the United States: Review of 2010,” the average co-payment for a generic drug was $6.06 per prescripton last year, compared with $23.65 to $34.77 for preferred and nonpreferred brand drugs.
“As this IMS analysis shows, having access to [a Food and Drug Administration]-approved generic version of a brand drug can cut the average co-pay for that medicine by more than 80%,” GPhA executive director Bob Billings said. “These are big savings for the hundreds of millions of Americans who have prescription drug coverage in their health insurance plans.”
Billings called for increase funding for the FDA’s Office of Generic Drugs to allow generics to get to market faster. Currently, the agency has a backlog of more than 2,000 applications, with as many as 365 of those applications related to new generic versions of branded drugs.