Postmarket Safety

Zohydro Picks Up More Opponents in Congress, States

The surge of opposition to Zogenix’s controversial painkiller Zohydro ER shows no signs of abating, with state officials joining congressional critics in calling for a reversal of the single-entity hydrocodone product’s approval. Read More

Sagent Latest Drugmaker to Recall Leaky Injectables

Sagent Pharmaceuticals is the latest drugmaker to recall products with leaky containers, notifying healthcare providers that two lots of its Zoledronic Acid Injection product may not be sterile after finding that four premix bags had been compromised. Read More

EMA Launches RMP Transparency Pilot

The European Medicines Agency (EMA) on Tuesday launched its latest transparency effort, publishing the first of many summaries of drugmakers’ risk management plans (RMP) that it plans to make available throughout 2014. Read More