FDA approves new MS drug
CAMBRIDGE, Mass. — The Food and Drug Administration has approved a new drug for multiple sclerosis.
Sanofi subsidiary Genzyme announced that the FDA had approved Aubagio (teriflunomide) as a once-daily, oral treatment for patients with relapsing MS.
"We are very excited to introduced Aubagio as a new treatment option that can make a difference in the lives of people with multiple sclerosis," Genzyme president and CEO David Meeker said. "The approval of our first MS therapy represents an important milestone for Genzyme and underscores our commitment to long-term leadership and partnership in the MS community."
FDA approves new leukemia drug
SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating a rare type of leukemia, the agency said Thursday.
The FDA approved South San Francisco, Calif.-based Talon Therapeutics’ Marqibo (vincristine sulfate liposome), an injectable drug for Philadelphia chromosome-negative acute lymphoblasic leukemia, or Ph-negative ALL.
The drug, which consists of the widely used anti-cancer drug vincristine encased within a liposome — a drug delivery system made of a material similar to cell membranes — is approved for patients whose leukemia has returned twice or more or has progressed after two or more regimens of therapy.
According to the National Cancer Institute, part of the National Institutes of Health, more than 6,000 people will be diagnosed with ALL this year, and 1,440 will die from it. The disease is a rapidly progressing form of blood and bone marrow cancer more common in children than adults.
FDA approves Lupin contraceptive
BALTIMORE — The Food and Drug Administration has approved a generic contraceptive drug made by Lupin Pharmaceuticals, the company said Tuesday.
Lupin announced the approval of norgestimate and ethinyl estradiol tablets in the 0.18/0.025-mg, 0.215/0.025-mg and 0.25/0.025-mg strengths.
The drug is a generic version of Ortho Tri-Cyclen Lo, made by Johnson & Johnson subsidiary Janssen Pharmaceuticals. The branded version of the drug had sales of about $421 million during the 12-month period ended in March, according to IMS Health.