The FDA warned that a transdermal patch used to treat ADHD in children and adolescents can lead to chemical leukoderma, or permanent skin discoloration, as a result of the skin's repeated exposure to specific chemical compounds.
China's Zhuhai United Laboratories bills itself as the world's largest manufacturer of the API for the antibiotic amoxicillin. But the sterile manufacturing for some of its amoxicillin products has been called into question by inspectors in Europe, which is banning the sterile drugs for now, except in limited cases.
When Akorn bought Hi-Tech Pharmacal a couple of years ago, CEO Raj Rai called the $640 million deal transformative. Most recently, what has transformed for Illinois-based Akorn is recalls tied to manufacturing issues at Hi-Tech.
Drugmakers are hot to trot after diabetes meds, and for good reason--the disease population is large, and growing. But the drugs have raised a few eyebrows lately, with regulators taking aim at safety issues tied to SGLT2 and DPP-4 drugs in particular. And SGLT2 and DPP-4 meds are not the only offenders, as side effect reports continue to mount for GLP-1 drugs.
After warning that casual use of testosterone meds can cause heart attack and stroke, the FDA has finally put its foot down to curb overprescribing of the drugs. But some say the agency needs to go further.
The FDA has already admitted that it made a mistake with its initial approval letter for Vanda Pharmaceuticals' sleep disorder drug early last year, a consumer advocacy group says. And now, that group is demanding the agency do a better job fixing it.
Just weeks after winning the first case to go to trial that accused Pfizer of hiding birth defect risks for the children of women who took the antidepressant Zoloft during pregnancy, the pharma giant has again convinced a jury that there was no credible connection. The results are positive for Pfizer, but the company still faces more than 1,000 lawsuits alleging similar claims.
Proton pump inhibitors, including AstraZeneca's longtime blockbuster Nexium, are some of the most commonly used drugs in the world to treat heartburn. But they may also be increasing the risk of heart attack, a new study shows.
Last month, Merck & Co. said Januvia passed its heart safety test. Now, the much-anticipated TECOS trial has had its airing at the American Diabetes Association meeting, and the study authors say the drug is in the clear.
Dermal fillers are meant to minimize the appearance of wrinkles and give the face a smoother, fuller appearance. But they may also have some nasty consequences if injected incorrectly, and so the FDA is calling for some updated labeling on the products.