Amneal receives FDA approval for generic painkiller
HAUPPAUGE, N.Y. Amneal Pharmaceuticals has received approval from the Food and Drug Administration to manufacture a generic version of a painkiller made by Johnson & Johnson, the generic drug maker announced Monday.
Amneal said the FDA had approves its generic tramadol/acetaminophen tablets in the 37.5-mg/325-mg strength. The drug is a generic version of Ultracet, made by J&J subsidiary Ortho-McNeil Janssen. Ultracet had sales of $61 million, according to IMS Health data from June 2009.
The drug is used for short-term treatment of moderately severe acute pain and is a controlled substance in some states. The company began shipping the tablets, made at its Hauppauge, N.Y., plant, on Jan. 25.
“Tramadol/APAP is a logical extension of our well-established tramadol line, which enjoys a solid market share in the industry,” Amneal EVP sales and marketing Jim Luce said. “Our total commitment to rapidly expanding our product portfolio, manufacturing the highest-quality products and delivering outstanding customer service combined to power Amneal’s prescription growth of 114% from 2008 to 2009, the highest in the generics industry, according to IMS Health.”
Artificial pancreas may benefit young Type 1 diabetes patients
LONDON Sleeping overnight with an artificial pancreas system benefits children and teenagers with Type 1 diabetes, according to a study published in the Feb. 5 issue of The Lancet.
The study, funded by the Juvenile Diabetes Research Foundation and conducted by researchers at the University of Cambridge in England, had participants aged 5 to 18 spend the night in a hospital using a combination of commercially available blood glucose sensors and insulin pumps controlled by a computer program that determined insulin dosage based on blood glucose levels.
The study found that the patients had targeted blood glucose levels for twice as long when they used the artificial pancreas system than when they used conventional therapy.
“These studies show that automated systems not only can help people manage diabetes by maintaining good control, they will also improve quality of life for the people with Type 1 diabetes and their families by lowering the risk of hypoglycemia,” University of Cambridge Institute of Metabolic Science researcher and lead study author Roman Hovorka said. “These results suggest that closed-loop devices may be able to significantly lower the patient’s risk of developing complications later in life by reducing or even overcoming the burden of hypoglycemia.”
FDA issues warning over safety of Tysabri use
ROCKVILLE, Md. Patients using a drug for treating multiple sclerosis may be at increased risk of developing a deadly brain infection, the Food and Drug Administration said Friday in a warning to healthcare professionals and patients.
The FDA said that 31 patients using the drug Tysabri (natalizumab), marketed by Elan Corp. and Biogen Idec, had developed progressive multifocal leukoencephalopathy, or PML, as of Jan. 21. The drug’s safety labeling has been updated to reflect the risk. Still, the agency said the benefits of the drug outweigh the potential risks.
PML is caused by the JC virus, a virus that occurs naturally in most adults but is kept in check by the body’s immune system. When the immune system becomes compromised due to diseases such as AIDS or the use of immune-suppressing drugs, the risk that the virus will multiply and cause irreversible and fatal damage to the brain increases.