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The FDA Tuesday ordered drugmakers in the $1.6 billion testosterone-replacement therapy market to update their labels with warnings of the potential for increased heart attack risks when used for aging-related low testosterone. Read More
Advocacy group Public Citizen is urging the FDA to pull oral forms of the antifungal drug ketoconazole from U.S. shelves due to serious health risks. Read More
Quality problems at an India contract manufacturer are prompting Sagent Pharmaceuticals to recall its injectable atracurium besylate and shift manufacturing of the drug to its U.S. facility, leading to a likely shortage of the product. Read More
Postmarket monitoring results on Hospira’s biosimilar of Janssen’s Remicade continue to show comparable patient response to the reference, the generics maker says. Read More
A New Jersey-based drug compounder and two of its top corporate officials have been indicted on fraud charges for repackaging and distributing unsterile drugs to several states. Read More
Generic drugmakers charge a December draft guidance doesn’t go far enough in enabling them to obtain bioequivalence testing batches for drugs protected by REMS product safety protocols. Read More
The FDA warned that counterfeit versions of Eli Lilly’s popular erectile dysfunction drug Cialis were found in mail to a U.S. customer — marking the first major counterfeit incident of 2015. Read More
The European Medicines Agency has published a 100-page technical guide aimed at helping drugmakers comply with a new global standard on the reporting of individual case safety reports. The standard, ISO EN 27953-2, takes effect July 1. Read More
The U.S. Food and Drug Administration warned last month that counterfeit versions of Eli Lilly’s popular erectile dysfunction drug Cialis were found in mail to a U.S. customer — marking the first major counterfeit incident of 2015. Read More
Drugs containing the antihistamine hydroxyzine should be taken at the lowest effective dose for the shortest possible time to minimize heart risks, a drug safety committee in the EU says. Read More