SILVER SPRING, Md. — The Food and Drug Administrtion on Thursday announced that it had approved Merrimack Pharmaceuticals’ Onivyde (irinotecan liposome) injection. The drug is a treatment for metastatic pancreatic cancer in combination with fluoracil and leucovorin.
“Many FDA staff who review drug applications are clinicians as well, so it’s especially rewarding when we are able to expedite access to new treatments for patients with unmet needs,” said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “By using the Priority Review designation for the application for Onivyde, patients will have earlier access to a drug that helps extend survival.”
Onivyde includes a boxed warning about potential risks of sever neutropenia and diarrhea among patients being treated with it.
PISCATAWAY, N.J. — Camber Pharmaceuticals announced Thursday that it had launched its generic version of Singulair (montelukast sodium) chewable tablets. The drug is indicated for chronic asthma treatment in adults and children ages 1 year and older.
Camber will sell 4- and 5-mg tablets in bottles of 30 and 90, and will sell 10-mg tablets in 30-, 90- and 1000-count bottles.
The workshops, sponsored by McKesson, have been offered by the Alexandria, Va.-based organization for more than 20 years and are slated to take place June 8-10 in Denver, Colo., and Oct. 4-6 in Boston. Read more