Report: FDA may consider strengthening generic drug regulations
BETHESDA, Md. The Food and Drug Administration could decide that some generic drugs are not equivalent to their branded counterparts, according to published reports.
Bloomberg reported FDA Center for Drug Evaluation and Research director Janet Woodcock as saying in an interview that the agency was considering strengthening regulations on some generic drugs because some did not appear to work as well as the branded versions, based on statements from some patients and generic drug company employees. Woodcock had just given a speech at a technical conference organized by the FDA and the Generic Pharmaceutical Association.
In 2008, controversy arose amid anecdotal reports that patients taking generic drugs for epilepsy had experienced breakthrough seizures that they had not experienced while taking the branded versions of the drugs. That gave rise to the introduction of generic “carve-out” legislation in 35 states that would have placed restrictions on when a generic drug can be used, though only three of them passed.
Cardiovascular, diabetes risk associated with prostate cancer drug class
SILVER SPRING, Md. Patients taking a certain class of drugs mostly used for prostate cancer may be at higher risk of heart disease and diabetes, the Food and Drug Administration warned on Wednesday.
The FDA said it would require manufacturers to add new warnings to gonadotropin-releasing hormone agonists. GnRH agonists suppress the production of testosterone and are used in androgen-deprivation therapy in men with prostate cancer. Some of the drugs also are used to treat women with endometriosis and children with precocious puberty. GnRH agonists include Abbott’s Lupron (leuprolide acetate), Sanofi-Aventis’ Eligard (leuprolide acetate), Watson Pharmaceuticals’ Trelstar (triptorelin pamoate) and several other branded and generic drugs.
The agency said in May that analyses had found that patients taking GnRH agonists had a small increased risk for diabetes, heart attack, stroke and sudden death.
Nutramax’s joint health supplement featured in book
EDGEWOOD, Md. CosaminASU was named a preferred joint health supplement in a new book, "FrameWork for the Knee."
“In ‘FrameWork for the Knee,’ Dr. Nick DiNubile continues to stress the importance of exercise, nutrition and the mind in maintaining health,” said Troy Henderson, VP corporate operations and professional services at Nutramax Labs. “Physicians repeatedly recommended Cosamin products because of their high-quality ingredients and Nutramax Labs’s strict adherence to [good manufacturing practices].”
Added the book’s author Dr. Nick DiNubile, “Not only do I take CosaminASU myself, I also recommend CosaminASU to my patients who have joint issues and who have had cartilage regeneration type of surgery, such as microfracture or chondrocyte transplantation.”