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Amarin has sued the FDA, seeking five years of market exclusivity for its prescription fish oil drug Vascepa, which the agency last week granted only three years of exclusivity. Read More
The FDA and the European Medicines Agency (EMA) have completed their analysis of study data on incretin-based type 2 diabetes drugs and conclude they do not increase the risk for pancreatitis or pancreatic cancer. Read More
Endo Pharmaceuticals has entered into a five-year corporate integrity agreement with HHS to resolve marketing violations surrounding the Lidoderm patch, a popular painkiller. Read More
Generic drug giants Teva and Mylan are just some of the 13 companies tapped by the FDA to participate in its Secure Supply Chain Pilot Program, an initiative five years in the making that will grant the companies’ U.S. product imports expedited treatment. Read More
The China Food and Drug Administration is renewing its push to have all manufacturers of blood products, vaccines and sterile injectables obtain a revised good manufacturing practices (GMP) certificate. Read More
A control laboratory testing facility in Mumbai, India, has come under fire from the FDA after a summer inspection last year raised serious concerns about the quality of drugs tested there. Read More
New authorities granted to the FDA in 2012 that stiffened penalties for drug counterfeiters are failing to curb the problem of fake drugs because they do not apply to distributors of counterfeits. Read More
The FDA says sponsors of antiretroviral drugs should submit clinical trial data sets that include patient data, endpoint data, genotypic data and phenotypic data when reporting data on HIV-1 resistance to the agency in support of an HIV drug. Read More
Drugmakers seeking marketing authorization in Australia will soon be able to make complete submissions in electronic format, allowing for cost savings and potentially swifter reviews. Read More
As calls for revoking the FDA’s approval of Zogenix’s painkiller Zohydro ER continue to grow, lawmakers are now questioning whether a public-private industry partnership tainted the agency approval process. Read More