For Endo's testosterone therapy Aveed, the third time wasn't the charm with the FDA--but the fourth time was. After a trio of rejections, the FDA has given the thumbs up to the Low-T drug, and the Malvern, PA-based company expects to launch it this month. But amid the safety questions surrounding testosterone drugs, doing so may not be so easy.
Is Pfizer and Bristol-Myers Squibb's Eliquis really safer than its competitors? A recent analysis of FDA adverse events reports suggested that it is.
What's the safest anticoagulant? According to AdverseEvents, which analyzes and distills data filed with the FDA, that would be Eliquis, the latest entrant into the warfarin alternative market.
Studies are popping up that highlight safety risks associated with testosterone drug use, and the FDA said last month it would reassess the issue after two years of monitoring. But so far, the agency hasn't drawn any conclusions on whether testosterone treatments increase the risk of stroke, heart attack or death--and so a public advocacy group is taking matters into its own hands.
In its second trip through the FDA, Chelsea Therapeutics' antidizziness drug came out a winner, securing approval to fight faintness in patients with a rare disorder, but not without a daunting label and some strings attached.
Durect suffered a regulatory setback with the FDA rejection of its Posidur treatment for postoperative pain.
Looks like the FDA has taken an advisory committee's Xarelto concerns to heart. Following up on an overwhelming "no" vote from last month, the agency Friday issued Johnson & Johnson's Janssen unit complete response letters regarding use of the anticoagulant in ACS patients.
Pradaxa has become a bigger legal headache for Boehringer Ingelheim. The German drugmaker says it's facing more than 2,000 lawsuits in the U.S., filed by patients claiming the anticoagulant drug caused severe or fatal bleeding.
The FDA has rejected Durect's pain therapy Posidur, telling the biotech that investigators didn't provide sufficient data to prove that it could be safely administered. And regulators sent Durect back to the drawing board, instructing the company to do additional safety studies if it still wants to seek an approval for the drug, intended to ease postsurgical pain.
Five days after the FDA announced it would investigate the heart and stroke dangers of testosterone-enhancing drugs, 5 lawsuits were filed against Abbott Laboratories and its spinoff AbbVie by men who claimed they suffered heart attacks or strokes after using one of those products, AndroGel.