Mylan’s generic Wellbutrin XL enters market
PITTSBURGH Mylan has launched a generic version of a common antidepressant, the company said Friday.
Mylan announced the launch of bupropion hydrochloride extended-release tablets in the 150-mg and 300-mg strengths, a once-daily treatment for depression.
The drug is a generic version of GlaxoSmithKline’s Wellbutrin XL. Various versions of the drug had sales of around $752 million during the 12-month period ended in June, according to IMS Health.
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.