Teva files second citizen’s petition with FDA over Copaxone
NEW YORK Teva Pharmaceutical Industries again is asking the Food and Drug Administration not to approve generic versions of its branded multiple sclerosis drug, according to published reports.
According to news reports, the drug maker filed a second citizen’s petition with the FDA asking the agency not to approve generic versions of the drug Copaxone (glatiramer acetate) made by Mylan and Momenta Pharmaceuticals. The company had filed the first citizen’s petition earlier in the year.
Teva has said the drug is “highly complicated” to develop, and given its own inability to fully characterize the drug’s active ingredients, it has “serious doubts” about another drug company’s ability to make a comparable generic version.
The company’s petition follows a suit it filed in the U.S. District Court for the Southern District of New York earlier this year against Momenta and Sandoz to prevent them from making generic versions of the drug.
Hyderabad, India-based drug maker Natco Pharma also announced last week that it had filed an approval application with the FDA for a generic version of Copaxone.
FDA accepts NDA for new Aricept formulation
WOODCLIFF LAKE, N.J. Eisai and Pfizer announced that the Food and Drug Administration has accepted for review Eisai’s new drug application for its Alzheimer’s disease treatment.
Once daily 23-mg Aricept (donepezil HCl extended release) tablets is a new higher dose formulation contains 23-mg of donepezil HCl in an extended release, matrix-type tablet with a delivery system that allows for gradual release of the drug. The NDA is based on a head-to-head clinical study comparing the 23-mg Aricept extended release tablet to the currently marketed once daily 10-mg Aricept (donepezil HCl) immediate release tablet. More than 1,400 patients with moderate to severe Alzheimer’s disease were enrolled in this global study.
Acceptance of the NDA indicates that the FDA has found the company’s submission to be sufficiently complete to review. Eisai and Pfizer believe this new formulation will potentially provide physicians, patients and their families with another option for the management of Alzheimer’s disease, the companies stated.
Study finds spike in morbid obesity rates among Type 2 diabetics
NEW YORK A Loyola University Health System study has found that 1-out-of-5 Type 2 diabetics is morbidly obese — approximately 100 lbs. or more overweight.
“The rate of morbid obesity among people with diabetes is increasing at a very alarming rate, and this has substantial public health implications,” said Dr. Holly Kramer, a kidney specialist and lead author of the study published online in the Journal of Diabetes and its Complications.
Kramer and colleagues examined data from the National Health and Nutrition Examination Surveys completed during the years 1976 to 2006. The surveys, known as NHANES, included interviews and physical examinations of representative samples of the U.S. population.
The study found a 141% increase in the rate of morbid obesity among adults with Type 2 diabetes between 1976 to 1980 and 2005 to 2006. More than 60% of U.S. adults with Type 2 diabetes are obese, and 20.7% are morbidly obese. Further, 1-in-3 African-American adults with Type 2 diabetes is morbidly obese.