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.
Mylan settles with Sunovion over generic asthma, COPD drug
PITTSBURGH — A unit of generic drug maker Mylan has settled with Sunovion Pharmaceuticals over a drug used to treat chronic obstructive pulmonary disease and asthma.
Mylan announced Tuesday that it had reached a settlement in a patent litigation suit that Sunovion, which used to operate under the name Sepracor, had filed against Dey Pharma, now known as Mylan Specialty, concerning the drug Xopenex (levalbuterol hydrochloride).
Under the agreement, Mylan can continue to sell a concentrate version of the drug in the 1.25-mg/0.5 mL strength and will have a royalty-bearing license to sell the nonconcentrate version in the 0.31 mg/3 mL, 0.63 mg/3 mL and 1.25 mg/3 mL strengths once they receive approval from the Food and Drug Administration. The settlement also releases Mylan from having to pay the $18 million in damages that a grand jury had required it to pay to Sunovion.