On May 17, the FDA announced that it released a draft guidance that sets out rules for compounding animal drugs from bulk substances. In so doing, the FDA is recognizing that in some situations, treating animals with specially formulated versions of approved drugs would be impossible.
In a report to Congress this week, the Office of Inspector General said that the number of inspections of generic drugmakers, preapproval and so-called surveillance inspections, were up to 243 in 2013 from 149 in 2011, a 63% jump. The vast majority of those were combined inspections for both preapproval applications and to check on general GMP conditions.
A Canadian-based company that sources active pharmaceutical ingredients from China and repackages them in Toronto is recalling hundreds of bulk APIs sold in the past three years because the facility where they were packaged didn't adequately separate penicillin APIs from the rest.
Takeda is preparing to pony up $2.3 billion to settle lawsuits accusing the Japanese pharma of hiding diabetes med Actos' cancer risks. But according to some experts, that's a steal.
3M announced the launch of its Tegarderm CHG intravenous port dressing, saying the device will help oncology patients receive injections comfortably and ward off infection. The new product combines a transparent port-site dressing with a chlorhexidine gluconate gel pad. 3M says the dressing enables continuous, unobstructed observation of the IV insertion site.
Pfizer racked up an important win in the first trial over Zoloft's alleged links to birth defects. A St. Louis jury decided on Friday that the drug giant isn't liable for congenital abnormalities in a boy whose mother took Zoloft during her pregnancy.
Sanofi is suing startup Diagnosia over the publication of information about side effects and drug interactions in its physician decision support software.
Iowa's KemPharm, maker of abuse-resistant versions of painkillers, has set its price range for a possible IPO, seeking up to $56 million at $12 to $14 a share.
Pfizer researchers found evidence last year that pregnant women using its Zoloft antidepressant had a higher risk of giving birth to a child with heart problems and other congenital anomalies, Bloomberg reports. Now, the internal report has surfaced in a lawsuit blaming Zoloft for a young boy's heart defect, the first such case to go to trial.
Just weeks after recalling three lots of 0.9% sodium chloride injection amounting to nearly 600,000 units, Baxter has recalled 8 more lots, adding further to the national shortage of saline. Last time the problem was leaky bags. This time the drugmaker says there is a problem with the chance for particulate in the bags. The FDA also announced the recall in a MedWatch notice.