FDA has eye on companies that sell oral colchicine
SILVER SPRING, Md. The Food and Drug Administration is cracking down on companies that sell an unapproved treatment for gout, the agency said Thursday.
The FDA announced that it had taken action against companies that manufacture, distribute and market single-ingredient oral colchicine, a drug that has existed since the early 1800s. Only one single-ingredient colchicine drug, Mutual Pharmaceutical’s and URL Pharma’s Colcrys, is approved for treating gout.
The FDA said a number of single-ingredient oral colchicine drugs have been used for decades, but they have not received approval from the modern FDA.
Teva receives complete response letter for Neutroval
JERUSALEM The Food and Drug Administration declined to approve a Teva biosimilar, the generic drug maker said Thursday.
Teva said it received a complete response letter from the FDA concerning Neutroval (filgrastim), for neutropenia in patients receiving chemotherapy for cancer. The FDA issues complete response letters when it needs additional information before it can approve a drug.
Neutroval is a biosimilar of Amgen’s Neupogen and is marketed in Europe under the name TevaGrastim.
GSK halts Simplirix trial
LONDON British drug maker GlaxoSmithKline has stopped a late-stage trial of a vaccine for genital herpes, citing disappointing results, GSK said Thursday.
The company said that while the vaccine Simplirix (herpes simplex vaccine) proved to be safe when administered to women as a prevention for genital herpes disease, it did not prevent infection. GSK had been conducting the phase 3 trial in 8,323 women ages 18 to 30 years in the United States and Canada under a partnership with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.
“We would like to express our gratitude toward our partner, [the National Institute of Allergy and Infectious Diseases], for [its] proactive collaboration and substantial contribution in the program, and the volunteers for their participation in the study,” GSK VP and director for late clinical development Gary Dubin said.